ElpiscienceBiopharmaceuticalsInc.-B：ApplicationProof(1stsubmission).pdf

《ElpiscienceBiopharmaceuticalsInc.-B：ApplicationProof(1stsubmission).pdf》由會員分享，可在線閱讀，更多相關《ElpiscienceBiopharmaceuticalsInc.-B：ApplicationProof(1stsubmission).pdf（596頁珍藏版）》請在三個皮匠報告上搜索。

1、The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibilityfor the contents of this Application Proof,make no representation as to its accuracy or completeness andexpressly disclaim any liability whatsoever for any loss howsoever arising from or in relian

2、ce upon the wholeor any part of the contents of this Application Proof.Application Proof ofElpiscience Biopharmaceuticals,Inc.科望醫藥集團(the“Company”)(Incorporated under the laws of the Cayman Islands with limited liability)WARNINGThe publication of this Application Proof is required by The Stock Exchan

3、ge of Hong Kong Limited(the“Exchange”)and the Securities and Futures Commission(the“Commission”)solely for the purpose ofproviding information to the public in Hong Kong.This Application Proof is in draft form.The information contained in it is incomplete and is subject to changewhich can be materia

4、l.By viewing this document,you acknowledge,accept and agree with the Company,itssole sponsor,sole sponsor-overall coordinator,advisers or members of the underwriting syndicate that:(a)this document is only for the purpose of providing information about the Company to the public in HongKong and not f

5、or any other purposes.No investment decision should be based on the informationcontained in this document;(b)the publication of this document or supplemental,revised or replacement pages on the Exchangeswebsite does not give rise to any obligation of the Company,its sole sponsor,sole sponsor-overall

6、coordinator,advisers or members of the underwriting syndicate to proceed with an offering in HongKong or any other jurisdiction.There is no assurance that the Company will proceed with the offering;(c)the contents of this document or any supplemental,revised or replacement pages may or may not berep

7、licated in full or in part in the actual final listing document;(d)the Application Proof is not the final listing document and may be updated or revised by the Companyfrom time to time in accordance with the Rules Governing the Listing of Securities on the Exchange;(e)this document does not constitu

8、te a prospectus,offering circular,notice,circular,brochure oradvertisement offering to sell any securities to the public in any jurisdiction,nor is it an invitation to thepublic to make offers to subscribe for or purchase any securities,nor is it calculated to invite offers bythe public to subscribe

9、 for or purchase any securities;(f)this document must not be regarded as an inducement to subscribe for or purchase any securities,andno such inducement is intended;(g)neither the Company nor any of its affiliates,advisers or members of the underwriting syndicate isoffering,or is soliciting offers t

10、o buy,any securities in any jurisdiction through the publication of thisdocument;(h)no application for the securities mentioned in this document should be made by any person nor wouldsuch application be accepted;(i)the Company has not and will not register the securities referred to in this document

11、 under the UnitedStates Securities Act of 1933,as amended,or any state securities laws of the United States;(j)as there may be legal restrictions on the distribution of this document or dissemination of anyinformation contained in this document,you agree to inform yourself about and observe any such

12、restrictions applicable to you;and(k)the application to which this document relates has not been approved for listing and the Exchange andthe Commission may accept,return or reject the application for the subject public offering and/or listing.If an offer or an invitation is made to the public in Ho

13、ng Kong in due course,prospective investors arereminded to make their investment decision solely based on the Companys prospectus registered withthe Registrar of Companies in Hong Kong,copies of which will be made available to the public duringthe offer period.IMPORTANT:If you are in any doubt about

14、 any of the contents of this document,you should obtain independent professional advice.Elpiscience Biopharmaceuticals,Inc.科望醫藥集團(Incorporated under the laws of the Cayman Islands with limited liability)REDACTEDNumber of REDACTED underthe REDACTED:REDACTED SharesNumber of REDACTED:REDACTED Shares(su

15、bject toreallocation)Number of REDACTED:REDACTED Shares(subject toreallocation)Maximum REDACTED:HK$REDACTED per REDACTED,plusbrokerage of 1.0%,SFC transaction levyof 0.0027%,Stock Exchange trading feeof 0.00565%,and AFRC transaction levyof 0.00015%(payable in full onapplication in Hong Kong dollars

16、andsubject to refund)Nominal Value:US$0.0001 per ShareREDACTED:REDACTEDSole Sponsor,REDACTED,REDACTED,REDACTED and REDACTEDHong Kong Exchanges and Clearing Limited,The Stock Exchange of Hong Kong Limited and Hong Kong Securities Clearing Company Limited take no responsibilityfor the contents of this

17、 document,make no representation as to its accuracy or completeness,and expressly disclaim any liability whatsoever for any loss howsoeverarising from or in reliance upon the whole or any part of the contents of this document.A copy of this document,having attached thereto the documents specified in

18、“Appendix V Documents Delivered to the Registrar of Companies and Available onDisplay”to this document,has been registered by the Registrar of Companies in Hong Kong as required by section 342C of the Companies(Winding Up andMiscellaneous Provisions)Ordinance(Chapter 32 of the Laws of Hong Kong).The

19、 Securities and Futures Commission of Hong Kong and the Registrar of Companiesin Hong Kong take no responsibility as to the contents of this document or any other document referred to above.The REDACTED is expected to be determined by agreement between the REDACTED(for itself and on behalf of the RE

20、DACTED)and us on theREDACTED.The REDACTED is expected to be on or about REDACTED and,in any event,not later than 12:00 noon on REDACTED.The REDACTEDwill be not more than HK$REDACTED and is currently expected to be not less than HK$REDACTED.Applicants for REDACTED may be required to pay(subject to ap

21、plication channels),on application,the maximum REDACTED of HK$REDACTED for each REDACTED together with brokerage of 1.0%,SFCtransaction levy of 0.0027%,Stock Exchange trading fee of 0.00565%and AFRC transaction levy of 0.00015%,subject to refund if the REDACTED should belower than HK$REDACTED.If,for

22、 any reason,the REDACTED(for itself and on behalf of the REDACTED)and us are unable to reach an agreement onthe REDACTED,the REDACTED will not proceed and will lapse.The REDACTED(for itself and on behalf of the REDACTED)may,where considered appropriate and with our consent,reduce the number of REDAC

23、TEDand/or the indicative REDACTED range that stated in this document at any time prior to the morning of the last day for lodging applications under theREDACTED.In such a case,notices of the reduction in the number of REDACTED and/or the indicative REDACTED range will be published on the websitesof

24、the Stock Exchange at www.hkexnews.hk and our Company at as soon as practicable following the decision to make such reduction,andin any event not later than the morning of the last day for lodging applications under the REDACTED.For more details,see the sections headed“Structure of theREDACTED”and“H

25、ow to Apply for Hong Kong REDACTED”in this document.Prior to making an REDACTED decision,prospective REDACTED should consider carefully all of the information set out in this document,including but notlimited to the risk factors set out in the section headed“Risk Factors”in this document.The obligat

26、ions of the REDACTED under the REDACTED to REDACTED for,and to procure applicants for the REDACTED for,the REDACTED,are subject to termination by the REDACTED(for itself and on behalf of the REDACTED)if certain grounds arise prior to 8:00 a.m.on theREDACTED.Such grounds are set out in the section he

27、aded“REDACTED REDACTED Arrangements and Expenses REDACTED Groundsfor Termination”in this document.The REDACTED have not been and will not be registered under the U.S.Securities Act or any state securities law in the United States and may not beREDACTED,sold,pledged or transferred within the United S

28、tates,except that REDACTED may be REDACTED,sold or delivered outside the United Statesin offshore transactions in reliance on Regulation S.REDACTEDIMPORTANTREDACTEDTHIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEA

29、DED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDIMPORTANT ii THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDIMPORTANT iii THIS DOCUMENT IS IN DRAFT FORM,INCOMP

30、LETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDIMPORTANT iv THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADE

31、D“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDEXPECTED TIMETABLE(1)v THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDEXPECTED TIMETABLE(1)vi THIS DOCUMENT IS IN

32、 DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDEXPECTED TIMETABLE(1)vii THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJ

33、UNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTEDEXPECTED TIMETABLE(1)viii THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.IMPORTANT NOTICE T

34、O REDACTEDThis document is issued by us solely in connection with the REDACTED and theREDACTED and does not constitute an offer to sell or a solicitation of an offer to buyany security other than the REDACTED offered by this document pursuant to theREDACTED.This document may not be used for the purp

35、ose of,and does notconstitute,an offer or a solicitation of an offer to subscribe for or buy,any security inany other jurisdiction or in any other circumstances.No action has been taken to permita REDACTED of the REDACTED or the distribution in any jurisdiction other thanHong Kong.The distribution o

36、f this document and the REDACTED and sale of theREDACTED in other jurisdictions are subject to restrictions and may not be madeexcept as permitted under the applicable securities laws of such jurisdictions pursuant toregistration with or authorization by the relevant securities regulatory authoritie

37、s or anexemption therefrom.You should rely only on the information contained in this document to make yourREDACTED decision.We have not authorized anyone to provide you with informationthat is different from what is contained in this document.Any information orrepresentation not made in this documen

38、t must not be relied on by you as having beenauthorized by us,the Sole Sponsor,the REDACTED,the REDACTED,theREDACTED,the REDACTED and the REDACTED,any of the REDACTED,any of our or their respective directors,officers or representatives,or any other personor party involved in the REDACTED.EXPECTED TI

39、METABLE.vCONTENTS.ixSUMMARY.1DEFINITIONS.20GLOSSARY OF TECHNICAL TERMS.33FORWARD-LOOKING STATEMENTS.46RISK FACTORS.48WAIVERS AND EXEMPTIONS.115INFORMATION ABOUT THIS DOCUMENT ANDTHE REDACTED.127DIRECTORS AND PARTIES INVOLVED IN THE REDACTED.132CONTENTS ix THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AN

40、D SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.CORPORATE INFORMATION.136INDUSTRY OVERVIEW.138REGULATORY OVERVIEW.163HISTORY AND CORPORATE STRUCTURE.191BUSINESS.247RELATIONSHIP WITH OUR SINGLE LARGEST GROUP OFSHARE

41、HOLDERS.352DIRECTORS AND SENIOR MANAGEMENT.359SUBSTANTIAL SHAREHOLDERS.379SHARE CAPITAL.381FINANCIAL INFORMATION.385FUTURE PLANS AND REDACTED.421REDACTED.425STRUCTURE OF THE REDACTED.435HOW TO APPLY FOR REDACTED.445APPENDIX IACCOUNTANTS REPORT.I-1APPENDIX IIUNAUDITED REDACTED FINANCIALINFORMATION.II

42、-1APPENDIX IIISUMMARY OF THE CONSTITUTION OF OURCOMPANY AND CAYMAN ISLANDSCOMPANY LAW.III-1APPENDIX IVSTATUTORY AND GENERAL INFORMATION.IV-1APPENDIX VDOCUMENTS DELIVERED TO THE REGISTRAROF COMPANIES AND AVAILABLE ON DISPLAY.V-1CONTENTS x THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANG

43、E AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.This summary aims to give you an overview of the information contained in thisdocument.As this is a summary,it does not contain all the information that may beimportant to you.You shou

44、ld read this document in its entirety before you decide toREDACTEDintheREDACTED.TherearerisksassociatedwithanyREDACTED.Some of the risks involved in REDACTED in the REDACTED areset out in the“Risk Factors”section of this document.You should read that sectioncarefully before you decide to REDACTED in

45、 the REDACTED.In particular,we area biotechnology company seeking to REDACTED on the Main Board of the StockExchange under Chapter 18A of the Listing Rules as we do not meet the requirementsunder Rule 8.05(1),(2)or(3)of the Listing Rules.There are unique challenges,risks anduncertaintiesassociatedwi

46、thREDACTEDincompanieslikeours.YourREDACTED decision should be made in light of these considerations.OVERVIEWFounded in 2017,we are a clinical-stage biopharmaceutical company with a global focuson developing next-generation cancer therapies.We have one Core Product,ES102,a clinicallyadvanced hexavale

47、nt OX40 agonist antibody.ES102 has shown a favorable safety profile andpromising anti-tumor activity in its clinical trials,including in combination with programmedcell death protein 1(“PD-1”)antibodies for non-small cell lung cancer(“NSCLC”)andesophageal squamous cell carcinoma(“ESCC”)patients resi

48、stant to PD-1 checkpointinhibitors.As of the Latest Practicable Date,we had multiple pipeline assets in addition to ourCore Product,three of which were at the clinical stage.Drivenbyourdeepunderstandingandpioneeringresearchinthetumormicroenvironment(“TME”),we aim to drive innovation in immuno-oncolo

49、gy by taking asystematic approach to cover innovative and promising targets and pathways in cancer biology.Growing evidence point to the condition of the TME as a major factor in the limited efficacyof immune checkpoint inhibitors(“ICIs”).“Cold”tumors,characterized by a suppressive TMEand a lack of

50、T cell infiltration,not only are less responsive to ICIs but also develop resistanceto ICIs after initial treatment.We are revolutionizing cancer treatment by turning“cold”tumors“hot,”namely removing suppressive factors in the TME,inducing higher immuneresponse across tumor types,and thereby enablin

51、g more robust anti-tumor activity.ES102,our Core Product,is positioned to target cancer patients responding poorly toICIs.We have completed two phase 1 clinical trials for ES102 as a single agent and incombination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors in Chinasince

52、in-licensing the asset from Inhibrx in 2018.We also initiated ES102s phase 2 clinicaltrial in combination with toripalimab in patients with advanced NSCLC in China in January2024 to further explore ES102s potential in combination therapies.We do not intend toactively pursue the development of ES102

53、as a monotherapy at this time,considering the morecompelling clinical benefits observed in ES102s combination trials to date and the competitiveSUMMARY 1 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNIN

54、G”ON THE COVER OF THIS DOCUMENT.landscape of cancer treatments.We believe our resources will be better utilized by strategicallyprioritizing the development of ES102s combination therapies,which also potentiallymaximizes ES102s treatment benefits to cancer patients.The pipeline chart below summarize

55、s the development status of our clinical-stage drugcandidates and selected preclinical assets.AssetTargetRegimenIndications(Lines of Treatment)Discovery/PreclinicalIND-EnablingPhase IPhase IIPhase IIIKey Regulatory AuthoritiesTrial Locations(as of the LatestPracticable Date)Partners(if applicable)ES

56、102/INBRX-106OX40 Combo(+PD-1inhibitor)NMPAChinaNMPAFDA,EMAChinaGlobal*ES014CD39/TGFMonoNMPA,FDAChinaSelf-developedNMPA,FDA/ES104/CTX-009/Tovecimig VEGF/DLL4MonoNMPANMPAChinaFDAU.S.ChinaES009LILRB2Core ProductMono or Combo(+PD-1 inhibitor)TGAAustraliaSelf-developedES028Moleculesforautoimmuneindicati

57、onsSIRP/CLDN18.2/Self-developedSelf-developedES019 andup to threeotherBiMEmoleculesSIRP/TAAsUndisclosedMonoIBD and RASolid TumorsTrial conducted by our CompanyTrial conducted by our partners/In-licensed fromIn-licensed fromSelf-developed&Collaborationwith7GlobalRights125134678Greater ChinaRightsGlob

58、alRights34Combo(+PD-1inhibitor)Mono/Combo(+PD-1 inhibitor)Combo(+PD-1inhibitor)Combo(+Chemotherapy)Mono or Combo(+Chemotherapy)Combo(+PD-1inhibitor chemotherapy)NSCLC(2L)HNSCC(1L)NSCLC(2L),HNSCC(1L)and other solid tumorsSolid Tumors,including NSCLC,ESCC,GIST and STS(2L)Solid Tumors,including NSCLC,E

59、SCC,GIST and STS(2L)CRC(3L)Solid Tumors,including BTC(2L)Combo(+Chemotherapy)BTC(2L)Solid Tumors,including OC and CRC(2L)Solid Tumors,including GC andPDACGreater ChinaRightsTrial SponsorOur CompanyOur CompanyInhibrxOur CompanyOur CompanyOur CompanyCompassOur CompanyOur Company/Abbreviations:NSCLC:no

60、n-small-cell lung cancer;HNSCC:head and neck squamous cell carcinoma;BTC:biliary tract cancer;CRC:colorectal cancer;ESCC:esophageal squamous cell carcinoma;GC:gastric cancer;GIST:gastrointestinal stromal tumor;OC:ovarian cancer;PDAC:pancreatic ductal adenocarcinoma;PD-1:programmed cell death protein

61、 1;PD-L1:programmeddeath-ligand 1;PD-(L)1:PD-1 or PD-L1;STS:soft tisue sarcoma;IBD:inflammatory bowel disease;RA:rheumatoid arthritis*Not including Greater China,unless with our prior consentNotes:1.Phase 1 clinical trial for ES102 in combination with toripalimab in patients with advanced solid tumo

62、rs in China wascompleted in May 2024.We are currently enrolling patients for ES102s phase 2 clinical trial in combination with toripalimabin patients with advanced NSCLC in China.Subject to clinical progress and our communication with the NMPA,either aphase 3 clinical trial in China for ES102 in pat

63、ients with advanced NSCLC or a phase 2/3 clinical trial in China for ES102in patients with advanced HNSCC,will be initiated by the second half of 2026;2.Inhibrx has advanced ES102(INBRX-106)s phase 1/2 clinical trials in the U.S.in patients with advanced solid tumors(including NSCLC).In June 2024,In

64、hibrx also initiated a phase 2/3 trial in the U.S.for ES102(INBRX-106)in combinationwith Keytruda as a first-line treatment for patients with locally advanced recurrent or metastatic HNSCC;3.We are enrolling patients for ES014s ongoing dose expansion study of its phase 1 clinical trial as a single a

65、gent in patientswith advanced solid tumors in China.We also obtained IND approval from the NMPA in March 2025 to initiate ES014scombination trial with a PD-1 checkpoint inhibitor;4.Phase 1 of a phase 1/2 trial in China for ES104 as a single agent in patients with advanced CRC was completed in March2

66、023.An IND approval from the NMPA for ES104s combination trial in patients with advanced solid tumors was obtainedin 2023;SUMMARY 2 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS

67、 DOCUMENT.5.Compass is currently conducting a phase 2/3 registrational-intent trial in the U.S.for ES104(CTX-009/tovecimig)incombination with paclitaxel in patients with previously treated,unresectable advanced or metastatic BTC.Compass releasedtop-line data in April 2025 showing that the primary en

68、dpoint of this trial had been met,and announced that full results ofthe trial,including key secondary endpoints,are expected to be released in the fourth quarter of 2025;6.ES009 is planned to be developed for the treatment of OC,CRC and other solid tumors.Phase 1 trial for ES009 commencedin Australi

69、a and enrolled the first patient in September 2023,with the dose escalation study completed in February 2025.Weare also exploring opportunities to collaborate with business partners to jointly advance ES009s clinical development in oroutside China;7.As of the Latest Practicable Date,ES028 was at pre

70、clinical stage.ES028 is expected to be developed as a monotherapy andalso has the potential to be combined with chemotherapy in earlier lines of therapy;8.As of the Latest Practicable Date,ES019 was at preclinical stage.ES019 is expected to be developed as a monotherapy andalso has the potential to

71、be combined with chemotherapy.Other BiME molecules covered or may be covered by ourcollaboration with Astellas were at discovery stage;9.We and Astellas agree to conduct early-stage research activities on ES019 and up to three other programs derived from ourBiMEplatform.In connection with this colla

72、boration,we have granted to Astellas(i)an exclusive license to develop anduse,during the respective research collaboration term,the antibodies and products with respect to each BiME researchprogram worldwide;and(ii)an option to obtain an exclusive license to further develop,manufacture,commercialize

73、 andotherwise exploit the antibodies and products with respect to each BiME research program worldwide.As of the LatestPracticable Date,Astellas had not exercised this option or obtained such post-option license with respect to any of the BiMEresearch programs.In addition to our focus on immuno-onco

74、logy,we are pursuing treatment options forautoimmune diseases by restoring immune balance and preventing excessive immuneactivation through a systemic and targeted approach.Leveraging our deep understanding of theintricate immune network,we aim to uncover key pathways involved in immune dysregulatio

75、nand develop innovative therapies that rebalance the immune response.Our strategy targets bothinnate and adaptive immunity focusing on key immunoregulatory pathways to achievelong-term disease control.For more details on our autoimmune pipeline,all of which were inthe preclinical stage as of the Lat

76、est Practicable Date,see“Business Our Pipeline OurAutoimmune Approach.”OUR PIPELINEWecombineourinternaldiscoveryanddevelopmentcapabilitieswithexternalpartnerships.The two complementary approaches provide us with the flexibility needed tocontinuously bring innovative and differentiated molecules into

77、 the clinic.Key highlights of our four clinical-stage programs are set forth below:ES102,our Core Product and a clinically advanced hexavalent OX40 agonist thatco-stimulates and activates T cells and reverses immune suppression induced byTreg cells.As of the Latest Practicable Date,there was no OX40

78、 agonist approvedworldwide,and ES102 was one of the only two OX40 agonist candidates in phase2 or beyond under clinical development globally,according to China InsightsIndustry Consultancy(“CIC”).For details,see“Industry Overview ChinasOX40 Agonist Market Competitive Landscape.”Positioned to target

79、cancerpatients responding poorly to ICIs,ES102 has shown a favorable safety profile andpromising anti-tumor activity in its clinical trials,including in combination withPD-1 antibodies for NSCLC and ESCC patients resistant to PD-1 checkpointinhibitors.SUMMARY 3 THIS DOCUMENT IS IN DRAFT FORM,INCOMPL

80、ETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.We have completed two phase 1 clinical trials for ES102 as a single agent and incombination with a PD-1 checkpoint inhibitor in patients with advanced solidtumo

81、rs in China since in-licensing the asset from Inhibrx in 2018.We also initiatedES102s phase 2 clinical trial in combination with toripalimab in patients withadvanced NSCLC in China in January 2024.Inhibrx has advanced ES102s clinicaltrials in the U.S.into phase 1/2 study in patients with advanced so

82、lid tumors(including NSCLC).In June 2024,Inhibrx also initiated a phase 2/3 trial in the U.S.for ES102 in combination with pembrolizumab as a first-line treatment for patientswith locally advanced recurrent or metastatic head and neck squamous cellcarcinoma(HNSCC).ES014,the first clinical-stage CD39

83、/TGF bsAb worldwide.ES014 is an innovativebifunctional anti-CD39/TGF?trap recombinant protein which not only blocks theCD39-adenosine pathway but also selectively concentrates the blockade of TGF?inthe vicinity of CD39-expressing immune cells(rather than directly on tumor cells,which rarely express

84、CD39).In our preclinical studies,ES014 has shown promisingsafety and efficacy with a potential to be used both as a monotherapy and incombination with other agents such as chemotherapy and PD-1 checkpointinhibitors.In contrast to other antibodies targeting the TGF?pathway(such asPD-L1/TGF?bsAbs),ES0

85、14 effectively blocks the suppression of immune cells byTGF?in in vivo studies.We are conducting the dose expansion study of a phase 1trial in China for ES014 in patients with advanced solid tumors,preliminary clinicaldata from which shows favorable safety and promising efficacy of ES014.Weobtained

86、IND approval from the NMPA for ES014s combination trial with a PD-1checkpoint inhibitor in March 2025.ES104,a differentiated bsAb that simultaneously targets VEGF and DLL4,twocritical signaling molecules in the formation of new blood vessels,or angiogenesis,in the tumor.As of the Latest Practicable

87、Date,ES104 was the only VEGF/DLL4bsAb under active clinical development worldwide.ES104 has shown anti-tumoractivity across multiple tumor types,such as biliary tract cancer(BTC),colorectalcancer(CRC)and gastric cancer(GC),based on data from its completed andongoing clinical trials.We have completed

88、 phase 1 of a phase 1/2 clinical trial forES104 in heavily pre-treated patients with advanced CRC in China since in-licensing the asset from TRIGR Therapeutics,Inc.(now Compass Therapeutics,Inc.,Nasdaq:CMPX)(“Compass”)in 2021.Compass is currently conducting aphase 2/3 registrational-intent trial in

89、the U.S.for ES104(CTX-009/tovecimig)incombination with paclitaxel in patients with previously treated,unresectableadvanced or metastatic BTC.Compass released top-line data in April 2025 showingthat the primary endpoint of this trial had been met,and announced that full resultsof the trial,including

90、key secondary endpoints,are expected to be released in thefourth quarter of 2025.In light of Compasss positive top-line data readout in thisongoingregistrational-intentstudy,weintendtoexpediteES104sclinicaldevelopment and commercialization in China.SUMMARY 4 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE

91、 AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.ES009,a differentiated mAb targeting LILRB2 with best-in-class potential.Antagonism of LILRB2 has shown to reprogram macrophages from an M2(anti-inflammatory)to M1

92、(pro-inflammatory)phenotype,making it a promisingtarget in creating an immune favorable TME.In our phase 1 clinical trial,ES009demonstrated promising efficacy with eight of the 11 patients achieving stabledisease,or a DCR of 72.7%,as of the data cut-off date(March 18,2025).In ourpreclinical studies,

93、ES009 demonstrated superior affinity and functional activitiesover other anti-LILRB2 antibodies by binding to a unique epitope,and synergisticeffects in combination with PD-1 checkpoint inhibitors to reinvigorate T cellfunction.In addition to our clinical-stage assets,we are currently developing sev

94、eral promisingpreclinical drug candidates,including ES028 and other assets covering novel targets addressingmajor cancer types such as gastric cancer(GC),pancreatic ductal adenocarcinoma(PDAC),NSCLC,HNSCC,hepatocellular carcinoma(HCC)and CRC,utilizing our systematic approachto early research on mech

95、anisms of action and comprehensive technology platforms.Ourautoimmune pipeline is represented by two innovative,multi-targeting molecules that areindicated for autoimmune indications including inflammatory bowel disease(“IBD”)andrheumatoid arthritis.For details,see“Business Our Pipeline.”WE MAY NOT

96、BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OURPIPELINE PRODUCTS,INCLUDING CORE PRODUCT ES102.OUR INTEGRATED INNOVATION CAPABILITIESWe have built an integrated drug development engine equipped with proprietarytechnologies covering the full R&D cycle,from drug discovery to translational medicine an

97、dclinical development.Proprietary drug discovery platforms.We have established proprietary antibodydiscovery platforms,namely(i)BiME,our fit-for-purpose macrophage engagerplatform,(ii)Acebody,our proprietary engineering platform for IgG-like bsAbs,and(iii)ElpiSource,our library for efficient selecti

98、on of fully human antibodies.In particular,programs emerging from our BiMEplatform are expected to offernew treatment options through the modulation of tumor-associated macrophages(“TAMs”),the most abundant leukocytes within the TME that correlate with ICIresistance in a wide range of tumor types.Bu

99、ilding on our technology platforms,ourpipeline comprises diverse modalities,including bsAbs and mAbs targeting variouspathways,providing flexibility in exploring both single-agent and combinationtherapies.SUMMARY 5 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMAT

100、ION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.Translational medicine capabilities.We have built a deep translational medicineexpertise to close the“bench-to-bedside”gap,aiming to translate scientific researchinto practical applications that can benefit

101、patients in a clinical setting.We utilizemultiple platform technologies to perform PK and PD studies and predictivebiomarker exploration.We leverage our deep understanding of tumor biology andtarget mechanism of action to strategically select indications and stratify patients forclinical programs.In

102、 addition to cytokine analysis and immune cell profiling,wehave adopted cutting-edge technologies including mouse gene editing for targetscreening,single cell sequencing and advanced bioinformatics to support ourtranslational medicine capabilities.Global clinical development capabilities.We aim to a

103、dvance our globallyinnovative and differentiated drug candidates through optimal regulatory pathwaystowards commercialization with maximum efficiency.Our execution capabilities aresupported by a global team with experience in regulatory affairs,clinical,pharmacovigilance,and clinical pharmacology.Ou

104、r team has a broad range ofexpertise in designing and leading first-in-human studies to executing large-scaleglobal registration trials.Our familiarity with regulatory environments in our keymarkets and close communications with regulatory authorities enable us to explorenovel pathways to rapidly ad

105、vance product approval.For details,see“Business Our Integrated Innovation Capabilities.”REDACTEDWe believe that the following competitive strengths have differentiated us from ourcompetitors:(i)key player in next-generation cancer immunotherapies with a systematic anddifferentiated strategy focusing

106、 on globally innovative targets and pathways in cancer biology;(ii)ES102,a clinically advanced hexavalent OX40 agonist antibody with potential to treat alarge population of ICI-resistant cancer patients;(iii)differentiated and innovative pipeline toseize vast and rapidly growing opportunities in the

107、 oncology market;(iv)integrated innovationcapabilities covering full R&D cycle;(v)proven business development capabilities drivingfuture growth;and(vi)experienced leadership and R&D team with a global vision backed byesteemed scientific advisers and renowned investors.For details,see“Business OurCom

108、petitive Strengths.”SUMMARY 6 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.OUR DEVELOPMENT STRATEGIESWe intend to capitalize on our competitive strengths by pursuing t

109、he followingdevelopment strategies:(i)rapidly advance our clinical assets towards commercialization;(ii)enrich our globally innovative cancer immunotherapy pipeline by optimizing our technologyplatforms,exemplified by BiME,and deepening our research in cancer biology;(iii)establisha strong global pr

110、esence through value-maximizing global partnerships and unlock the clinicaland commercial potential of our drug candidates;(iv)optimize our operation capabilities tofoster a sustainable and adaptable biotechnology enterprise.For details,see“Business OurDevelopment Strategies.”LICENSE AND COLLABORATI

111、ON ARRANGEMENTSWe actively seek collaboration and licensing partnerships with MNCs and leading biotechcompanies.These partnerships enable us to expand our global footprint and maximize theclinical and commercial value of our pipeline and technology platforms.Moreover,they arestrong endorsements of o

112、ur ability to develop next-generation cancer immunotherapies andcutting-edge technologies.In addition to our partnerships with Inhibrx and Compass to in-license ES102(INBRX-106)and ES104(CTX-009/tovecimig),respectively,we have entered into a strategicpartnershipwith AstellasPharmaInc.(“Astellas”)(TS

113、E:4503),agloballyleadingbiopharmaceutical company,to collaborate on the novel bispecific macrophage engagerprograms derived from our BiMEplatform.Upon Astellass exercise of its option,we areeligible to potentially receive more than US$1.7 billion in milestone payments,whileexpanding our global footp

114、rint leveraging Astellass strong presence in over 70 countries andregionsacrosstheworld.Fordetails,see“BusinessLicenseandCollaborationArrangements.”COMMERCIALIZATIONSubject to regulatory communications and marketing approval,we anticipate thecommercialization of our clinical-stage assets as early as

115、 2028.We plan to adopt a two-prongedapproach to rapidly deliver our innovative drugs to the patients in need by leveraging theexpertise and capabilities of external partners,while gradually establishing our in-house salesand marketing teams composed of experienced professionals covering key therapeu

116、tic areas inChina.For details,see“Business Commercialization.”SUMMARY 7 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.COMPETITIONOur industry is highly competitive and

117、subject to rapid and significant change.While webelieve that our innovative drug candidates in clinical and pre-clinical trials,R&D capabilities,our innovative technology platforms,and our experienced leadership team provide us withcompetitive advantages,we face potential competition from many other

118、s working to developtherapies targeting the same indications,especially companies involved in the research anddevelopment of cancer immunotherapies.These include major biopharmaceutical companies,specialty pharmaceutical and biotechnology companies,and academic institutions,governmentagencies and re

119、search institutions.Any drug candidates that we successfully develop andcommercialize will compete both with existing drugs and with any new drugs that may becomeavailable in the future.Our Core Product,ES102,is a clinically advanced hexavalent OX40 agonist antibody.The first OX40 agonist in China i

120、s expected to be approved by 2029 and Chinas OX40 agonistmarket is expected to reach RMB16.5 billion by 2035,growing at a CAGR of 99.6%from2029,according to CIC.For more information on the market opportunities and competitivelandscape of our drug candidates,see“Our Pipeline”and“Industry Overview.”IN

121、TELLECTUAL PROPERTYOur success depends on our ability to obtain and maintain protection for our technology,technical know-how and trade secrets related to our business,to defend and enforce ourintellectual property rights,and to operate our business without infringing,misappropriating,or otherwise v

122、iolating valid and enforceable intellectual property rights of others.As of theLatest Practicable Date,we owned six approved patents across major markets,including in theU.S.,China,Australia and Canada,and had filed 69 patent applications,including 17 PatentCooperation Treaty(“PCT”)patent applicatio

123、ns(including ten which have entered the nationalphase and two filed as priority applications),nine pending patent applications in China,sevenpending patent applications in the U.S.and 36 patent applications in other jurisdictions.As ofthe same date,we had in-licensed the Greater China rights relatin

124、g to(i)three patents relatedto ES104 issued in the PRC with expiration dates between 2033 and 2034;and(ii)eight patentapplications related to ES102,our Core Product,with expected expiration dates between 2036to 2039,comprising three pending in the PRC and five pending in other jurisdictions.Fordetai

125、ls,please see“Business Intellectual Property.”SUMMARY OF KEY FINANCIAL INFORMATIONThe summary of the key financial information set forth below have been derived from andshould be read in conjunction with our consolidated financial statements,including theaccompanying notes,set forth in the Accountan

126、ts Report in Appendix I to this document,aswell as the information set forth in the section headed“Financial Information.”SUMMARY 8 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS

127、 DOCUMENT.Summary of Consolidated Statements of Profit or LossThe following table sets forth a summary of our consolidated statements of profit or lossand other comprehensive income for the years indicated:For the year ended December 31,20232024(RMB000)Revenue?106,566Gross profit?106,566Other income

128、 and gains?44,44935,343Research and development costs?(107,704)(117,092)Administrative expenses?(44,821)(59,275)Fair value losses on convertible redeemablepreferred shares?(729,508)(39,571)Other expenses?(9,386)(9)Finance costs?(6,481)(3,302)Loss before tax?(853,451)(77,340)Income tax expense?(10,65

129、7)Loss and total comprehensive loss for the year?(853,451)(87,997)Attributable to:Owners of the parent?(853,451)(87,997)In 2023 and 2024,we recorded net losses of RMB853.5 million and RMB88.0 million,respectively,which were primarily due to(i)R&D costs incurred in connection with ourresearch and dev

130、elopment programs,(ii)administrative expenses incurred to support ourbusiness operations,and(iii)fair value losses on convertible redeemable preferred shares as aresult of fair value changes of our convertible redeemable preferred shares for the respectiveyears.For the year ended December 31,2024,we

131、 recorded revenue of RMB106.6 million,which was primarily derived from our collaboration,option and license agreement withAstellas.Fordetails,see“BusinessLicenseandCollaboration ArrangementsCollaboration with Astellas on Bispecific Macrophage Engager Programs Derived fromBiME.”SUMMARY 9 THIS DOCUMEN

132、T IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.Summary of Consolidated Statements of Financial PositionThe following table sets forth a summary of our consolidated statements of fin

133、ancialposition as of the dates indicated:As of December 31,20232024(RMB000)Total non-current assets?107,62423,491Total current assets?545,434554,340Total current liabilities?55,22155,690Net current assets?490,213498,650Total assets less current liabilities?597,837522,141Total non-current liabilities

134、?3,268,8183,259,723Net liabilities?2,670,9812,737,582We recorded net liabilities of RMB2,671.0 million and RMB2,737.6 million as ofDecember 31,2023 and 2024,respectively.Upon REDACTED,all the convertibleredeemable preferred shares will automatically convert to ordinary share and will bereclassified

135、from liabilities to equity.As a result,we expect our net liability position to turninto net asset position upon REDACTED.Our net current assets remained stable at RMB490.2 million and RMB498.7 million as ofDecember 31,2023 and 2024,respectively.SUMMARY 10 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AN

136、D SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.Summary of Consolidated Statements of Cash FlowsThe following table sets forth the components of our consolidated statements of cashflows for the years indicated:For

137、the year ended December 31,20232024(RMB000)Operating cash flows before movement inworking capital?(77,829)(19,023)Changes in working capital?(34,544)32,389Tax paid?(10,657)Net cash(used in)/from operating activities?(112,373)2,709Net cash from/(used in)investing activities?110,734(180,660)Net cash u

138、sed in financing activities?(70,933)(61,379)Net decrease in cash and cash equivalents?(72,572)(239,330)Cash and cash equivalents at beginning of year?339,096270,435Effect of foreign exchange rate changes?3,9111,714Cash and cash equivalents at end of year?270,43532,819We recorded net cash used in ope

139、rating activities of RMB112.4 million for the year endedDecember 31,2023,primarily due to our substantial R&D costs incurred during the year.Forthe year ended December 31,2024,we generated net cash from operating activities of RMB2.7million,which was primarily derived from our collaboration,option a

140、nd license agreementwith Astellas.For details,please see“Business License and Collaboration Arrangements Collaboration with Astellas on Bispecific Macrophage Engager Programs Derived fromBiME.”During the Track Record Period,we funded our operation primarily through bankborrowings and proceeds from e

141、quity financing.As of March 31,2025,the latest practicabledate for determining our indebtedness,we had cash and cash equivalents of RMB118.7 million.We currently do not have utilized banking facilities but may negotiate with financialinstitutions to secure additional credit lines or financing option

142、s based on our futureoperational needs.We expect to fund our future operations primarily with existing cash and cash equivalents,payments received from our license and collaboration agreements,and REDACTED fromthe REDACTED.Upon the successful commercialization of one or more of our drugcandidates,we

143、 expect to fund our operations in part with income generated from sales of ourcommercialized drug products.As our business continues to expand,we may require furtherfunding through equity offerings,debt financing,license and collaboration arrangements,andother sources.SUMMARY 11 THIS DOCUMENT IS IN

144、DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.We estimate that we will receive REDACTED of approximately HK$REDACTED inthe REDACTED,after deducting REDACTED commissions,fees and estimated

145、expensespayable by us in connection with the REDACTED,and assuming an REDACTED ofHK$REDACTED per Share,being the REDACTED of the indicative REDACTEDrange stated in this document.Assuming an average cash burn rate going forward of 1.7 timesthe level in the year ended December 31,2024,we estimate that

146、 our cash and cash equivalentsand time deposits as of March 31,2025 will maintain our financial viability for overREDACTED months from April 2025,without taking into account REDACTED%of theestimated REDACTED from the REDACTED(namely,the portion allocated for ourworking capital and other general corp

147、orate purposes);or,we estimate we will maintain ourfinancial viability for over REDACTED months from April 2025,if we take into accountREDACTED%of the estimated REDACTED from the REDACTED(namely,theportion allocated for our working capital and other general corporate purposes).As such,ourDirectors a

148、re of the view that we have sufficient working capital to cover at least 125%of ourcosts,including research and development expenses and administrative expenses(includingany production costs),for at least the next 12 months from the date of this document.Fordetails,see“Financial Information Liquidit

149、y and Capital Resources.”Key Financial RatiosThe following table set forth our key financial ratios as of the dates indicated:As of December 31,20232024Current ratio(1)?9.910.0Notes:(1)Current ratio represents current assets divided by current liabilities as of the same date.SUMMARY 12 THIS DOCUMENT

150、 IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.Cash Operating CostsThe following table sets forth our cash operating costs for the years indicated:For the year ended December 31,2023

151、2024(RMB000)Costs relating to research and development ofour Core ProductOutsourced R&D service fees?4,6324,847Employee costs?1,9036,836Raw material and consumables costs?11597Others?7151,165Subtotal?7,36512,945Costs relating to research and development ofour other drug candidatesOutsourced R&D serv

152、ice fees?59,18642,829Employee costs?26,81822,675Raw material and consumables costs?3,2834,846Others?6,0054,209Subtotal?95,29274,559Total?102,65787,504Workforce employment costs(1)?15,78116,631Direct production costs(2)?Product marketing(3)?Non-income taxes,royalties and othergovernmental charges?Con

153、tingency allowances?Notes:(1)Workforce employment costs represent total non-research and development personnel costs mainlyincluding salaries and benefits.(2)We had not commenced commercial-scale product manufacturing as of the Latest Practicable Date.(3)We had not commenced product sales as of the

154、Latest Practicable Date.SUMMARY 13 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.RISK FACTORSOur business faces risks including those set out in the section headed“Risk

155、 Factors.”Asdifferent investors may have different interpretations and criteria when determining thesignificance of a risk,you should read the“Risk Factors”section in its entirety before youdecide to REDACTED in our Company.Some of the major risks that we face include:(i)wedepend substantially on th

156、e success of our drug candidates.If we are unable to successfullycomplete clinical development,obtain regulatory approvals or achieve commercialization forour drug candidates,or if we experience significant delays or cost overruns in doing any of theforegoing,our business and prospects could be mate

157、rially and adversely affected;(ii)we faceintense competition and rapid technological change and the possibility that our competitorsmay develop therapies that are similar,more advanced,or more effective than ours,which mayadversely affect our financial condition and our ability to successfully comme

158、rcialize our drugcandidates;(iii)we have entered into license and collaboration arrangements and may form orseek strategic partnerships or enter into similar arrangements in the future,and we may notrealize the benefits of such partnerships or arrangements as expected;(iv)we have incurred netlosses

159、since our inception and anticipate that we will continue to incur net losses for theforeseeable future and may never achieve or maintain profitability;(v)if we are unable toobtain and maintain adequate patent and other intellectual property protection for our drugcandidates throughout the world,or i

160、f the scope of such intellectual property rights obtainedis not sufficiently broad,third parties could develop and commercialize products andtechnologies similar or identical to ours and compete directly against us,and our ability tosuccessfully commercialize our drug candidates may be adversely aff

161、ected;and(vi)the futurecommercial success of our drug candidates will depend on the degree of their marketacceptance among physicians,patients and others in the medical community.OUR SINGLE LARGEST GROUP OF SHAREHOLDERSAs of the Latest Practicable Date,LAV USD Entities,controlled by Dr.SHI Yi,wasint

162、erested in approximately 22.93%of the total number of issued Shares.Immediately aftercompletion of the REDACTED(subject to the Assumptions),LAV USD Entities,controlledby Dr.SHI Yi,will be interested in approximately REDACTED%of the total number ofissued Shares of our Company.Based on the above,prior

163、 to and upon REDACTED,Dr.SHIYi and LAV USD Entities are and will continue to be our Single Largest Group of Shareholders.For further details of the identity and background of our Single Largest Group of Shareholders,see“Substantial Shareholders”and“Relationship with Our Single Largest Group ofShareh

164、olders.”SUMMARY 14 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.PRE-REDACTED INVESTORSWe underwent four rounds of pre-REDACTED financings with an aggregate amount ofap

165、proximately US$251.5 million(equivalent to approximately RMB1,789.5 million)raisedsince our establishment.Our Pre-REDACTED Investors include certain SophisticatedInvestors,such as LAV USD,Shanghai Liyi,Greater Bay Area Fund,Hyfinity,Tencent andHillhouse,and each Sophisticated Investor has made meani

166、ngful investment in the Companyat least six months before the REDACTED,holding approximately REDACTED%,REDACTED%,REDACTED%,REDACTED%,REDACTED%andREDACTED%of the total issued Shares immediately following the completion of theREDACTED(subject to the Assumptions),respectively.It is expected that lock-u

167、pundertakings will be given by the Pre-REDACTED Investors to the REDACTED,pursuantto which each Pre-REDACTED Investor will agree that,subject to the terms of such lock-upundertakings,it will not,whether directly or indirectly,dispose of any of the Shares held bysuchPre-REDACTEDInvestoratanytimedurin

168、gtheperiodagreedbysuchPre-REDACTED Investor and the REDACTED.We utilized the proceeds from thePre-REDACTED Investments to finance our R&D activities,as well as to support theworking capital needs of our Group.For further details of the identity and background of ourPre-REDACTED Investors,and the pri

169、ncipal terms of the Pre-REDACTED Investments,see“History and Corporate Structure Pre-REDACTED Investments.”PREVIOUS LISTING ATTEMPTIn the first half of 2021,our Company contemplated pursuing a listing in the UnitedStates(the“Proposed U.S.Listing”).We filed listing application documents on a confiden

170、tialbasis with the SEC in August 2021.In view of the market conditions in the U.S.,we decidedto withdraw the application of the Proposed U.S.Listing in 2022.In 2024,our Companyconsidered the Stock Exchange a more suitable REDACTED venue and thus initiated thepreparation for REDACTED in Hong Kong.For

171、 further details of the Proposed U.S.Listing,see“History and Corporate Structure Previous Listing Attempt.”SHARE INCENTIVE SCHEMESAs of the Latest Practicable Date,we had conditionally granted an aggregate of13,476,563 options(representing the right to subscribe for 13,476,563 Shares)to 78 granteesu

172、nder the 2019 Share Incentive Plan,all of which will remain outstanding as of theREDACTED.The number of the Shares underlying such options will only be issued by ourCompany after the REDACTED if such options are fully vested and exercised.Therefore,there will be potential dilution effect on the shar

173、eholding of our Shareholders as of theREDACTED upon full exercise of all such 13,476,563 outstanding options.Subject to theAssumptions,the shareholding of our Shareholders upon completion of the REDACTED willbe diluted by approximately REDACTED%if all such outstanding options are fully vestedand exe

174、rcised.For further details,please see“Statutory and General Information D.ShareIncentive Schemes 1.2019 Share Incentive Plan”in Appendix IV to this document.SUMMARY 15 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION

175、 HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.For the purpose of the REDACTED,our Company has adopted the Post-REDACTEDShare Scheme on September 18,2024,the terms of which comply with the requirements ofChapter 17 of the Listing Rules.The Post-REDACTED Share Scheme will take effect uponthe REDACTED.

176、We will comply with the requirements under Chapter 17 of the ListingRules regarding the operation and administration of the Post-REDACTED Share Scheme.For further details,please see“Statutory and General Information D.Share IncentiveSchemes 2.Post-REDACTED Share Scheme”in Appendix IV to this documen

177、t.DIVIDENDSNo dividend has been paid or declared by our Company during the Track Record Period.Any future declarations and payments of dividends will be at the absolute discretion of ourBoard and if necessary,subject to the approval of our Shareholders at general meetings.Therecan be no assurance th

178、at we will be able to declare or distribute any dividend in the amountset out in any plan of the Board or at all.Currently,we do not have any dividend policy orintention to declare or pay any dividends in the near future.As advised by our legal adviser asto Cayman Islands law,notwithstanding that th

179、e Company may have accumulated losses,theCompany may declare dividend(a)out of profits of the Company if the Company has sufficientprofits,realized or unrealized,unless such is contrary to the accounting principles adopted bythe Company or(b)out of the share premium of the Company if following the d

180、ate on whichthe dividend is proposed to be paid,the Company is able to pay its debts as they fall due inthe ordinary course of business.In determining whether to declare a dividend,our Board willneed to be satisfied that the declaration of dividend is in the best interest of the Company andmay make

181、provision for losses.REDACTED should not purchase our Shares with theexpectation of receiving cash dividends.REDACTEDSUMMARY 16 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOC

182、UMENT.REDACTEDBased on anREDACTED ofHK$REDACTEDBased on anREDACTED ofHK$REDACTEDMarket capitalization of our Shares(1)?HK$REDACTEDHK$REDACTEDUnaudited REDACTED adjusted nettangible assets of the Group per Share(2)?HK$REDACTEDHK$REDACTEDNotes:(1)The calculation of the market capitalization is based o

183、n REDACTED Shares expected to be in issueimmediately after completion of the REDACTED.(2)The REDACTED adjusted net tangible liabilities of our Group per Share is arrived at after makingthe adjustments referred to in“Appendix II Unaudited REDACTED Financial Information”and onthe basis that REDACTED s

184、hares(being the outstanding 522,868,431 Shares as of December 31,2024and REDACTED Shares to be issued pursuant to the REDACTED)were in issue immediatelyfollowing the completion of the REDACTED assuming the REDACTED had completed onDecember 31,2024.REDACTEDWeestimatethatwewillreceiveREDACTEDfromtheRE

185、DACTEDofapproximately HK$REDACTED,after deducting REDACTED commissions,fees andestimated expenses payable by us in connection with the REDACTED,and assuming anREDACTED of HK$REDACTED per Share,being the REDACTED of the indicativeREDACTEDrangestatedinthisdocument.WecurrentlyintendtoapplytheseREDACTED

186、forthefollowingpurposes:(i)approximatelyREDACTED%,orHK$REDACTED,will be used for the research and development of our drug candidates,includingourCoreProductandotherdrugcandidates,including(a)approximatelyREDACTED%,or HK$REDACTED to advance the clinical development plan of our CoreProduct,ES102,and(b

187、)approximately REDACTED%,or HK$REDACTED to advancethe clinical development plan of ES014,ES104 and ES009,three of our clinical-stage drugcandidates;(ii)approximately REDACTED%,or HK$REDACTED,will be used tosolidify our proprietary technology platforms,develop our preclinical assets,and discover newd

188、rug candidates;(iii)approximately REDACTED%,or HK$REDACTED,will be used toprepare for the anticipated commercial launch of our drug candidates;and(iv)approximatelyREDACTED%,or HK$REDACTED,will be used for working capital and other generalcorporate purposes.For further details,please see“Future Plans

189、 and REDACTED.”SUMMARY 17 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTED EXPENSESREDACTED expenses to be borne by us are estimated to be approximatelyHK$REDACTE

190、D(assuming an REDACTED of HK$REDACTED per Share,being theREDACTED of the indicative REDACTED of HK$REDACTED to HK$REDACTEDperShare),representingapproximatelyREDACTED%oftheestimatedgrossREDACTED from the REDACTED.The REDACTED expenses consist of(i)REDACTED-related expenses,including REDACTED commissi

191、on,of approximatelyHK$REDACTED,and(ii)non-REDACTED-related expenses of approximately HK$REDACTED,comprising(a)fees and expenses of our legal advisers and reportingaccountants of approximately HK$REDACTED,and(b)other fees and expenses ofapproximatelyHK$REDACTED.WehadincurredREDACTEDexpensesofRMBREDAC

192、TED as of December 31,2024,of which RMBREDACTED had beenchargedtoourprofitorlossandRMBREDACTEDwasrecognizedasdeferredREDACTED expenses,which are expected to be recognized directly as a deduction fromequityupontheREDACTED.AftertheTrackRecordPeriod,approximatelyHK$REDACTED is expected to be charged to

193、 our consolidated statements of profit or loss,and approximately HK$REDACTED is expected to be accounted for as a deduction fromequity upon the REDACTED.The REDACTED expenses above are the latest practicableestimate for reference only,and the actual amount may differ from this estimate.RECENT DEVELO

194、PMENTS AND NO MATERIAL ADVERSE CHANGEBusiness ProgressSince the end of the Track Record Period,we have continuously developed our businessand continued to advance our pipeline.We are currently enrolling patients for ES102s phase2 clinical trial in combination with toripalimab in patients with advanc

195、ed NSCLC in China tofurther explore ES102s potential in combination therapies.We also completed the doseescalation study of ES009s phase 1 clinical trial in February 2025.In addition,we obtainedIND approval from the NMPA for ES014s combination trial with a PD-1 checkpoint inhibitorin March 2025.SUMM

196、ARY 18 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.Regulatory UpdatesOn December 20,2023,the U.S.Senate introduced a legislation that would prohibit U.S.federal gover

197、nment contracts,grants or loans to entities that use biotechnology equipment orservices provided by certain Chinese biotechnology companies.On September 9,2024,theU.S.House of Representatives voted in favor of a similar version of such legislation titled theBIOSECURE Act(the“BIOSECURE Act”).As of th

198、e Latest Practicable Date,theBIOSECURE Act had not been enacted into law.We are of the view that the proposedBIOSECURE Act,if enacted in its current form,would not have a material and adverse impacton our business,primarily because we,or any of our subsidiaries,are not a recipient of anyU.S.federal

199、government contracts,loans,grants or funding and do not anticipate applying forsuch contracts,loans,grants or funding in the future.Furthermore,to the best of ourknowledge,none of our business partners are using any services provided by us under therespective arrangements in connection with any fede

200、ral contracts,loans,grants or funding.Wewill continue to closely monitor and evaluate the potential impacts of the proposedBIOSECURE Act on our business and operations,including maintaining strong businessrelationships with all our existing suppliers and a list of qualified alternative suppliers cap

201、ableof providing equivalent services.No Material Adverse ChangeAfter performing due diligence work which our Directors consider appropriate andsufficient and after due and careful consideration,our Directors confirm that,except asdisclosed above and up to the date of this document,there has been no

202、material adverse changein our financial or trading position or prospects since December 31,2024,which is the end dateof the years reported on in the Accountants Report included in Appendix I to this document,and there is no event since December 31,2024 that would materially affect the information as

203、set out in the Accountants Report included in Appendix I to this document.SUMMARY 19 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.In this document,unless the context o

204、therwise requires,the following terms andexpressions shall have the meanings set out below.Certain technical terms are explainedin the section headed“Glossary of Technical Terms”in this document.“2019 Share Incentive Plan”the 2019 Share Incentive Plan adopted by our Companyon July 16,2019 and restat

205、ed and/or amended on April29,2021,October 25,2021,June 26,2024 and September18,2024,the principal terms of which are set out in thesection headed“Statutory and General Information D.Share Incentive Schemes 1.2019 Share IncentivePlan”in Appendix IV“Accountants Report”the accountants report of our Com

206、pany,the text of whichis set out in Appendix I to this document“affiliate”any other person,directly or indirectly,controlling orcontrolled by or under direct or indirect common controlwith such specified person“AFRC”Accounting and Financial Reporting Council“Articles”or“Articles ofAssociation”the ei

207、ghth amended and restated articles of association ofourCompanyconditionallyadoptedbyaspecialresolution passed on September 18,2024 and amended on with effect from the REDACTED,and as amendedfrom time to time,a summary of which is set out in“Summary of the Constitution of Our Company andCayman Island

208、s Company Law”in Appendix III to thisdocument“associate(s)”has the meaning ascribed to it under the Listing RulesREDACTED“Astellas”AstellasPharmaInc.,aglobalbiopharmaceuticalcompany established in Japan on April 1,2005,whoseshares are listed on the Tokyo Stock Exchange(stockcode:4503)DEFINITIONS 20

209、THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“Audit Committee”the audit committee of the Board“BIOSECURE Act”a proposed legislation published by the U.S.Senate onDecem

210、ber 20,2023 to prohibit federal contracting withcertain biotechnology providers connected to foreignadversaries;on January 25,2024,the U.S.House ofRepresentatives introduced an analogous version of suchlegislation,of which the U.S.House of Representativesvoted in favor on September 9,2024.As of the

211、LatestPracticable Date,the BIOSECURE Act had not beenenacted into law“Board”or“Board of Directors”the board of Directors of our Company“business day”or“Business Day”any day(other than a Saturday,Sunday or public holidayin Hong Kong)on which banks in Hong Kong aregenerally open for normal banking bus

212、iness“BVI”the British Virgin Islands“Cayman Companies Act”theCompanies Act,Cap22(Act3of1961,asconsolidated and revised)of the Cayman Islands asamended,supplemented,or otherwise modified fromtime to timeREDACTED“CDE”the Center for Drug Evaluation of the NMPA(國家藥品監督管理局藥品審評中心),adivisionoftheNMPAmainly

213、responsible for the review and approval of INDand NDA“China”or“the PRC”the Peoples Republic of China,but for the purpose ofthis document and for geographical reference only andexcept where the context requires otherwise,referencesin this document to“China”and the“PRC”do not applyto Hong Kong,the Mac

214、ao Special Administrative Regionand TaiwanDEFINITIONS 21 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“CIC”China Insights Industry Consultancy“CIC Report”the report pr

215、epared by CIC in connection with theREDACTED“close associate(s)”has the meaning ascribed to it under the Listing Rules“Companies Ordinance”the Companies Ordinance(Chapter 622 of the Laws ofHong Kong),as amended,supplemented or otherwisemodified from time to time“Companies(Winding Up andMiscellaneous

216、 Provisions)Ordinance”theCompanies(WindingUpandMiscellaneousProvisions)Ordinance(Chapter 32 of the Laws of HongKong),as amended,supplemented or otherwise modifiedfrom time to time“Company,”“our Company,”or“the Company”ElpiscienceBiopharmaceuticals,Inc.,anexemptedlimited liability company incorporate

217、d in the CaymanIslands on July 13,2017“Compass”Compass Therapeutics,Inc.,a clinical-stage,oncology-focused biopharmaceutical company incorporated underthe laws of Delaware of the United States,whose sharesare listed on the Nasdaq(Nasdaq:CMPX),and,where thecontextsorequires,includingitswhollyownedsub

218、sidiary TRIGR Therapeutics,Inc.“Compliance Adviser”First Shanghai Capital Limited“connected person(s)”has the meaning ascribed to it under the Listing Rules“connected transaction(s)”has the meaning ascribed to it under the Listing Rules“Core Product”has the meaning ascribed thereto in Chapter 18A of

219、 theListing Rules;for the purpose of this document,our CoreProduct refers to ES102“CSRC”the China Securities Regulatory Commission(中國證券監督管理委員會)“Director(s)”the director(s)of our CompanyDEFINITIONS 22 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ

220、 IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“EIT Law”PRC Enterprise Income Tax Law(中華人民共和國企業所得稅法)which was adopted by the National PeoplesCongress on March 16,2007,as last amended andeffective on December 29,2018“Elpiscience Australia”Elpiscience Biopharma Australia

221、 Pty.Ltd.,a companyincorporated under the laws of Australia with limitedliability on March 7,2022,is one of our wholly-ownedsubsidiaries“Elpiscience HK”Elpiscience Biopharmaceuticals Co.,Limited,a companyincorporated under the laws of Hong Kong with limitedliability on August 11,2017,is one of our w

222、holly-ownedsubsidiaries“Elpiscience Lingang”Elpiscience(Lingang)Biopharma,Ltd.(科望(上海)醫藥科技有限公司),a limited liability company incorporatedunder the laws of the PRC on November 11,2020,is awholly-owned subsidiary of Elpiscience Shanghai andone of our indirectly wholly-owned subsidiaries“Elpiscience Shan

223、ghai”Elpiscience Biopharma,Ltd.(科望(上海)生物醫藥科技有限公司),a limited liability company incorporated underthe laws of the PRC on September 30,2017,is awholly-owned subsidiary of Elpiscience HK and one ofour indirectly wholly-owned subsidiaries“Elpiscience Suzhou”Elpiscience(Suzhou)Biopharma,Ltd.(科望(蘇州)生物醫藥科技有

224、限公司),alimitedliabilitycompanyincorporated under the laws of the PRC on March 20,2018,is a wholly-owned subsidiary of Elpiscience HKand one of our indirectly wholly-owned subsidiaries“Elpiscience U.S.”Elpiscience Biopharmaceuticals USA,Inc.,a limitedliability company incorporated under the laws of th

225、eState of Delaware of the United States on June 21,2021and one of our wholly-owned subsidiaries“ESG”environmental,social and governanceDEFINITIONS 23 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON

226、 THE COVER OF THIS DOCUMENT.“Extreme Conditions”the occurrence of“extreme conditions”as announced byany government authority of Hong Kong due to seriousdisruptionofpublictransportservices,extensiveflooding,major landslides,large-scale power outage orany other adverse conditions before Typhoon Signal

227、 No.8 or above is replaced with Typhoon Signal No.3 orbelow“FDA”the United States Food and Drug Administration“FIL”the Foreign Investment Law of the PRC(中華人民共和國外商投資法)adoptedbytheNationalPeoplesCongress on March 15,2019 and became effective onJanuary 1,2020REDACTED“FVTPL”fair value through profit or

228、lossREDACTED“Greater China”mainlandChina,HongKong,theMacauSpecialAdministrative Region and Taiwan“Group,”“our Group,”“the Group,”“we,”“us,”or“our”our Company and its subsidiaries from time to time,andwhere the context requires,in respect of the period priorto our Company becoming the holding company

229、 of itspresent subsidiaries,such subsidiaries as if they weresubsidiaries of our Company at the relevant time“HK”or“Hong Kong”the Hong Kong Special Administrative Region of thePeoples Republic of ChinaREDACTEDDEFINITIONS 24 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE

230、 INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTED“Hong Kong dollars”or“HK dollars”or“HK$”Hong Kong dollars,the lawful currency of Hong KongREDACTEDDEFINITIONS 25 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE

231、INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTED“IFRS Accounting Standards”the International Financial Reporting Standards as issuedby the International Accounting Standards Board,whichincludestandards,amendmentsandinterpretationspromulgat

232、ed by the International Accounting StandardsBoard and the International Accounting Standards andInterpretation issued by the International AccountingStandards Committee“Independent Third Party(ies)”individual(s)or company(ies)which,to the best of ourDirectors knowledge,information,and belief,havingm

233、ade all reasonable enquiries,is/are not our connectedpersons“Inhibrx”Inhibrx Biosciences,Inc.,a clinical-stage biopharmaceuticalcompany incorporated under the laws of Delaware of theUnited States on January 8,2024,whose shares are listed onthe Nasdaq Global Market(Nasdaq:INBX),and,where thecontext s

234、o requires,its predecessor Inhibrx,Inc.In May 2024,Sanofi(Nasdaq:SNY)acquired Inhibrx,Inc.s INBRX-101 program.Immediately prior to theconsummation of that transaction,Inhibrx,Inc.spun offa new entity,Inhibrx Biosciences,Inc.,which assumedall of the employees,assets,and liabilities of Inhibrx notrela

235、ted to INBRX-101,including ES102(INBRX-106),the Companys Core Product originally in-licensed fromInhibrx,Inc.in 2018DEFINITIONS 26 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS

236、DOCUMENT.REDACTED“Junshi Biosciences”ShanghaiJunshiBiosciencesCo.,Ltd.(上海君實生物醫藥科技股份有限公司),aninnovation-drivenbiopharmaceutical company incorporated under the lawsof the PRC on December 27,2012,whose shares arelisted on both the Stock Exchange(stock code:1877)andthe Shanghai Stock Exchange(stock code:

237、688180)“Keytruda”Keytruda(pembrolizumab),a PD-1 blocking checkpointinhibitor,in patients with locally advanced or metastaticsolid tumors.KEYTRUDAis a registered trademark ofMerck Sharp&Dohme LLC,a subsidiary of Merck&Co.,Inc.,Rahway,NJ,USA“Latest Practicable Date”May 16,2025,being the latest practic

238、able date forascertaining certain information in this document beforeits publicationDEFINITIONS 27 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“LAV USD”LAV Epoch Limi

239、ted,LAV Biosciences Fund V,L.P.,LAVAmaranth Limited and LAV Azure Limited“LAV USD Entities”LAVUSDandtheinvestmentholdingvehiclescontrolling thereof,including LAV Biosciences Fund IV,L.P.,LAV GP IV,L.P.,LAV Corporate IV GP,Ltd.,LAVGP V,L.P.,LAV Corporate V GP,Ltd.,LAV BiosciencesFund III,L.P.,LAV GP

240、III,L.P.,LAV Corporate GP,Ltd.and Lilly Asia Ventures Fund III,L.P.,collectively.Forthe background and shareholding of LAV USD Entities,see“History and Corporate Structure InformationRegardingthePre-REDACTEDInvestors”and“Substantial Shareholders”REDACTED“Listing Committee”the listing committee of th

241、e Stock ExchangeREDACTED“Listing Guide”the Guide for New Listing Applicants published by theStock Exchange,as amended,supplemented or otherwisemodified from time to time“Listing Rules”the Rules Governing the Listing of Securities on TheStock Exchange of Hong Kong Limited,as amended,supplemented or o

242、therwise modified from time to time“Main Board”thestockexchange(excludingtheoptionmarket)operated by the Stock Exchange which is independentfrom and operates in parallel with the GEM of the StockExchange“MOFCOM”Ministry of Commerce of the PRC(中華人民共和國商務部)“Nasdaq”or“NASDAQ”the Nasdaq Stock Market in t

243、he United States“NDRC”National Development and Reform Commission of thePRC(中華人民共和國國家發展和改革委員會)DEFINITIONS 28 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“NMPA”the Nati

244、onal Medical Products Administration of the PRC(國家藥品監督管理局),the successor to the China Foodand Drug Administration(國家食品藥品監督管理總局)“NYSE”New York Stock Exchange“Nomination Committee”the nomination committee of the BoardREDACTED“Onshore Investors”Onshore Series A Investors,Onshore Series A+Investors,Onsh

245、ore Series B Investors and Onshore Series CInvestors“Post-REDACTED ShareScheme”the post-REDACTED share scheme adopted by ourCompany on September 18,2024,the principal terms ofwhich are set out in the section headed“Statutory andGeneral Information Share Incentive Schemes 2.Post-REDACTED Share Scheme

246、”in Appendix IV inthis document“PRC Legal Adviser”Jingtian&Gongcheng,PRClegaladvisertoourCompany“Pre-REDACTEDInvestment(s)”the pre-REDACTED investment(s)in our Companyundertaken by the Pre-REDACTED Investors,detailsof which are set out in the section headed“History andCorporate Structure Pre-REDACTE

247、D Investments”in this document“Pre-REDACTED Investor(s)”holders of the Series A Preferred Shares,Series A+Preferred Shares,Series B Preferred Shares and Series CPreferred Shares of our CompanyDEFINITIONS 29 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUST

248、BE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“Preferred Share(s)”Series A Preferred Shares,Series A+Preferred Shares,Series B Preferred Shares and Series C Preferred Shareswe issued during the series financingsREDACTED“R&D”research and development“Regulation S

249、”Regulation S under the U.S.Securities Act“Remuneration Committee”the remuneration committee of the Board“RMB”or“Renminbi”Renminbi,the lawful currency of the PRC“SAFE”the State Administration of Foreign Exchange of the PRC(中華人民共和國國家外匯管理局)“SAMR”State Administration for Market Regulation of the PRC(中華

250、人民共和國國家市場監督管理總局)“SCNPC”theStandingCommitteeoftheNationalPeoplesCongress of the PRC(全國人民代表大會常務委員會)“SEC”the Securities and Exchange Commission of the UnitedStates“SFC”the Securities and Futures Commission of Hong Kong“SFO”or“Securities andFutures Ordinance”Securities and Futures Ordinance(Chapter 571

251、of theLaws of Hong Kong),as amended,supplemented orotherwise modified from time to time“Share(s)”or“Ordinary Share(s)”ordinary share(s)in the share capital our Company witha par value of US$0.0001 each“Share Incentive Schemes”the2019ShareIncentivePlanandthePost-REDACTED Share SchemeDEFINITIONS 30 TH

252、IS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“Shareholder(s)”holder(s)of our Share(s)“Sole Sponsor”CITIC Securities(Hong Kong)Limited“Single Largest Group ofShareholders

253、”Dr.SHI Yi and LAV USD EntitiesREDACTED“Sophisticated Investor(s)”has the meaning ascribed to it under Chapter 2.3 of theListing Guide“STA”the State Taxation Administration(國家稅務總局)“Stock Exchange”The Stock Exchange of Hong Kong Limited“subsidiary(ies)”has the meaning ascribed to it in section 15 of

254、theCompanies Ordinance“substantial shareholder(s)”has the meaning ascribed to it in the Listing Rules“Takeovers Code”Code on Takeovers and Mergers and Share Buy-backsissuedbytheSFC,asamended,supplementedorotherwise modified from time to time“Track Record Period”the two years ended December 31,2023 a

255、nd 2024“Treasury Share(s)”the Shares repurchased and held by the Company intreasury,if any“TSE”The Tokyo Stock Exchange“U.S.”or“United States”theUnitedStatesofAmerica,itsterritories,itspossessions and all areas subject to its jurisdiction“U.S.dollars,”“US$”or“USD”United States dollars,the lawful cur

256、rency of the UnitedStates“U.S.Securities Act”the United States Securities Act of 1933,as amended,andthe rules and regulations promulgated thereunderDEFINITIONS 31 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEAD

257、ED“WARNING”ON THE COVER OF THIS DOCUMENT.REDACTED“VAT”value-added tax“WuXi AppTec”WuXi AppTec Co.,Ltd.(無錫藥明康德新藥開發股份有限公司),a joint stock company with limited liabilityincorporated in the PRC and whose H shares are listed onthe Stock Exchange(stock code:2359)and A shares arelisted on the Shanghai Stock

258、 Exchange(stock code:603259),and,where the context so requires,any of itssubsidiaries“WuXi Biologics”WuXi Biologics(Cayman)Inc.,an exempted companywith limited liability incorporated under the laws of theCayman Islands on February 27,2014,whose shares arelisted on the Stock Exchange(stock code:2269)

259、,and,where the context so requires,any of its subsidiaries“%”per centFor ease of reference,the names of Chinese laws and regulations,governmentalauthorities,institutions,naturalpersonsorotherentities(includingcertainofoursubsidiaries)have been included in this document in both the Chinese and Englis

260、h languagesand in the event of any inconsistency,the Chinese versions shall prevail.English translationsof company names and other terms from the Chinese language are provided for identificationpurposes only.DEFINITIONS 32 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE

261、INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.In this document,unless the context otherwise requires,explanations and definitionsof certain terms used in this document in connection with our Company and our businessshall have the meanings set ou

262、t below.The terms and their meanings may not alwayscorrespond to standard industry meaning or usage of these terms.“ADP”adenosine diphosphate“advanced solid tumors”late-stage cancers originating in solid tissues that arechallenging to treat,including(i)locally advanced solidtumors that have grown be

263、yond their original sites andinvaded nearby tissues or structures,but has not yetspread to distant parts of body,and(ii)metastatic solidtumors that have spread from their initial location tonearby tissue,lymph nodes,or distant parts of the body“advanced HNSCC”locally advanced and/or neck recurrent,a

264、nd metastatichead and neck squamous cell carcinoma,commonlyrefers to Stages III and IV HNSCC“advanced NSCLC”locally advanced and metastatic non-small cell lungcancer,commonly refers to unresectable Stages III andIV NSCLC“AE”adverse event,which may be mild,moderate,or severe,any untoward medical occu

265、rrence in a patient or subjectreceiving a drug or other pharmaceutical product in aclinical trial and which does not necessarily have a causalrelationship with the treatment“agonist”a chemical that binds to and activates a receptor or otherproteins to produce a biological response“ALK”anaplastic lym

266、phoma kinase,a receptor tyrosine kinaseprotein that is likely to play a role in the development andfunction of the nervous system“AMP”adenosine monophosphate“ATP”adenosinetriphosphate,anorganiccompoundandhydrotrope that provides energy to drive many processesin living cells“BC”breast cancerGLOSSARY

267、OF TECHNICAL TERMS 33 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“biomarker”a naturally occurring molecule,gene,or characteristic bywhich a particular pathological o

268、r physiological process,disease,etc.can be identified“bispecific antibody”or“bsAb”antibody that combines two antigen-recognizing elementsinto a single construct,able to bind to two differentantigens at the same time“BiTE”bispecific T cell engager“BLA”biologics license application“BRAF”a human gene t

269、hat encodes a protein called B-Raf whichaffectscelldivision,differentiationamongotherfunctions“BTC”biliary tract cancer“CAGR”compound annual growth rate“CD25”cluster of differentiation 25,a molecule that regulate Tcell activation and function“CD3”cluster of differentiation 3,a protein complex and T

270、cellco-receptor that is involved in activating the cytotoxic Tcell and T helper cell“CD39”cluster of differentiation 39,a molecule that can betherapeutically targeted to restore effector T-cell function“CD47”cluster of differentiation 47,a membrane protein whichprovides a“dont eat me”signal to macro

271、phages“CD4+T cells”a type of important T lymphocyte that helps coordinatingthe immune response by stimulating other immune cellsto fight infections“CD8+T cells”a type of important T lymphocytes for immune defenseagainst intracellular pathogens,including viruses andbacteria,and for tumor surveillance

272、GLOSSARY OF TECHNICAL TERMS 34 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“CDMO”contract development and manufacturing organization,acompany that provides support to

273、 the pharmaceutical,biotechnology,and medical device industries in the formof development and manufacturing services outsourcedon a contract basis“chemotherapy”a drug treatment that uses cytotoxic chemicals to killfast-growing cells in a patients body.It is most oftenused as a cancer treatment as ca

274、ncer cells grow andmultiply much faster than most cells in the body“cGMP”current good manufacturing practice“CLDN18.2”claudin 18.2,a member of the claudin protein family,located on the surface of cell membrane,and normallyexpressed at a low level in differentiated epithelial cellsof gastric mucosa“C

275、MC”chemistry,manufacturing and controls,also commonlyreferred to as process development,which covers thevarious procedures used to assess the physical andchemical characteristics of drug products,and to ensuretheir quality and consistency during manufacturing“cohort”a group of patients as part of a

276、clinical trial who share acommon characteristic or experience within a definedperiod and who are monitored over time“combination therapy”a treatment that uses more than one medication ormodality“CR”complete response,the disappearance of all signs ofcancer in response to treatment“CRC”colorectal canc

277、er,a type of cancer arising from the colonor rectum“CRO”contract research organization,a company that providessupporttothepharmaceutical,biotechnology,andmedical device industries in the form of research servicesoutsourced on a contract basis“CRS”cytokine release syndromeGLOSSARY OF TECHNICAL TERMS

278、35 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“CTLA-4”cytotoxic T-lymphocyte-associated protein 4,a proteinexpressed on all T cells and functions as an immunecheckpo

279、int that downregulates immune responses.It isone of the immune checkpoints commonly exploited bytumor cells to evade anti-tumor immune response“cytokine”a broad and loose category of small proteins that areimportant in cell signaling,whose release has an effect onthe behavior of cells expressing cor

280、responding receptors“cytotoxic”toxic to living cells“DC”dendritic cell“DCR”disease control rate,the total proportion of patients whodemonstrate a response to treatment,equal to the sum ofcomplete responses(CR),partial responses(PR)andstable disease(SD)“DOR”duration of response,the length of time tha

281、t a tumorcontinues to respond to treatment without the cancergrowing or spreading“DLL4”delta-like ligand 4,a protein with important functions inblood vessel development and tumor angiogenesis“DLT”dose-limiting toxicity,toxicities of a drug or othertreatment that are serious enough to prevent an incr

282、easein dose or level of that treatment“dose escalation study”a phase in a clinical trial in where different dose of anagent(e.g.a drug)are tested against each other toestablish which dose works best and/or is least harmful“dose expansion study”a trial enrolling additional participants to typicallyfu

283、rtherevaluateefficacy,safety,tolerability,pharmacokinetics and pharmacodynamics“dMMR”mismatch repair defect,ability of a cell in correctingmistakes made when DNA is copied in a cell.Mismatchrepair deficient cells usually have many DNA mutations,which may lead to cancer“EC”esophageal cancerGLOSSARY O

284、F TECHNICAL TERMS 36 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“EGFR”epidermal growth factor receptor“ESCC”esophageal squamous cell carcinoma“Fc”crystallizable frag

285、ment,which is the tail region of anantibody that interacts with cell surface receptors calledFc receptors and some proteins of the complement system“first-line”or“1L”with respect to any disease,the first-line treatment,whichis the treatment regimen or regimens that are generallyacceptedbythemedicale

286、stablishmentforinitialtreatment.It is also called primary treatment or therapy“five-year survival rate”a type of survival rate for estimating the prognosis of aparticular disease,normally calculated from the point ofdiagnosis“GC”gastric cancer“GCP”goodclinicalpractice,aninternationalethicalandscient

287、ific quality standard for the performance of aclinical trial on medicinal products involving humans“GIST”gastrointestinal stromal tumor“GLP”good laboratory practice“HCC”hepatocellular carcinoma,a type of cancer commonlyarising from hepatocytes in predominantly cirrhotic liver“HER2”humanepidermalgrow

288、thfactorreceptor2,theoverexpression of which promotes the development ofvarious types of cancer such as breast cancer,gastriccancer and colorectal cancer“HLA-G”human leukocyte antigen G,a molecule for mediatingmaternal-fetaltoleranceandregulatingimmuneresponses“HNC”head and neck cancer“HNSCC”head an

289、d neck squamous cell carcinoma“IARC”International Agency for Research on CancerGLOSSARY OF TECHNICAL TERMS 37 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“IBD”inflamm

290、atory bowel disease,disorders involving long-standing inflammation of tissues in digest tract“ICI(s)”immunecheckpointinhibitor(s),atypeofimmunotherapythatblocksproteinscalledimmunecheckpointsthatpreventtheimmunesystemfromattacking the cancer cells“IFN?”interferongamma,acytokineforactivationandregula

291、tion of the immune system“IgG”immunoglobulin G,the most common type of antibodyfound in blood circulation that plays an important role inantibody-based immunity against invading pathogens“IL-2”interleukin 2,a cytokine with essential roles in theimmune system via its direct effects on T cells“immunot

292、herapy”a type of therapy that uses substances to stimulate orsuppress the immune system to help the body fightcancer,infection,and other diseases“IND”investigational new drug or investigational new drugapplication,also known as clinical trial application inChina or the U.S.“in vivo”Latin for“within

293、the living”,studies in vivo are those inwhich the effects of various biological or chemicalsubstancesaretestedonwhole,livingorganismsincluding animals,humans and plants,as opposed to apartial or dead organism,or those done in vitro“in vitro”Latin for“within the glass”,studies using components ofan o

294、rganism that have been isolated from their usualbiological surroundings,such as microorganisms,cells orbiological molecules“JSC”joint steering committee“key opinion leaders”influencers and trusted persons who have expert productknowledge and influence in a respective field and are animportant part o

295、f burgeoning industries and businesses inChina,including biotech/pharmaceutical industriesGLOSSARY OF TECHNICAL TERMS 38 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“

296、leukocytes”part of the bodys immune system that help the body fightinfection and other diseases“LILRB2”aninhibitoryreceptorpredominantlyexpressedonmyeloid cells that elicits profound immune suppression“mAb”monoclonal antibody,an antibody generated by identicalimmune cells that are all clones of the

297、same parent cell“MAD”maximum administered dose,the highest dose that is safeto be administered to patients“mCRC”metastatic colorectal cancer“MC38”a murine colon adenocarcinoma cell line widely used inimmuno-oncology model with significant utility in drugdevelopment“melanoma”a form of skin cancer tha

298、t arises when pigment-producingcells,also known as melanocytes,mutate and becomecancerous“metastatic”in reference to any disease,including cancer,diseaseproducing organisms or malignant or cancerous cellstransferred to other parts of the body by way of the bloodor lymphatic vessels or membranous sur

299、faces“MHC”major histocompatibility complex,a large locus onvertebrate DNA containing a set of closely linkedpolymorphic genes that code for cell surface proteinsessential for the adaptive immune system“MNC”multinational corporations“monocyte(s)”a type of white blood cell(leukocytes)that reside inblo

300、od and tissues to find and destroy germs and eliminateinfected cells“monotherapy”therapy that uses a single drug to treat a disease orcondition“MSI-H”microsatellite instability-high“MSS”microsatellite stableGLOSSARY OF TECHNICAL TERMS 39 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANG

301、E AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“MTD”maximum tolerated dose,the highest dose of a drug ortreatment that does not cause unacceptable side effects“NCCR”National Central Cancer Registry of China“NDA”new drug application

302、“NTRK”a class of oncogenes associated with a wide range ofpediatric and adult solid tumors“NSCLC”non-small cell lung cancer“OC”ovarian cancer“oncology”a branch of medicine that deals with tumors,includingstudy of their development,diagnosis,treatment andprevention“ORR”overall objective response rate

303、,proportion of patientswith a complete response or partial response to treatment“OS”or“overall survival”the length of time from either the date of diagnosis or thestart of treatment for a disease that patients diagnosedwith the disease are still alive,used in clinical trials as ameasurement of a dru

304、gs effectiveness“OX40”amemberofthetumornecrosisfactorreceptorsuperfamily expressed on activated T cells that givescostimulatory signals to promote T cell division andsurvival“OX40L”a ligand for OX40,belonging to a member of the TNFsuperfamily that regulates immune responses“PCC”preclinical candidate

305、s“PCT”the Patent Cooperation Treaty,an international patent lawtreaty,concluded in 1970.It provides a unified procedurefor filing patent applications to protect inventions in eachof its contracting states.A patent application filed underthe PCT is called an international application,or PCTapplicatio

306、n.A PCT application shall enter national phasesin selected contracting states within specified deadline topursue patent protection in such jurisdictionsGLOSSARY OF TECHNICAL TERMS 40 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION W

307、ITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“PDAC”pancreatic ductal adenocarcinoma“PD-1”programmed cell death protein 1,an immune checkpointreceptor expressed on T cells,B cells and macrophages“PD-L1”PD-1 ligand 1,which is a protein on the surface of anormal cell or a cancer cell th

308、at binds to its receptor,PD-1,on the surface of the T cell that causes the T cellto turn off its ability to kill the cancer cell“PD-(L)1”referring to PD-1 or PD-L1“PFS”progression free survival,the length of time during andafter the treatment that a patient lives without the diseasegetting worse“pha

309、se 1 clinical trial”a study in which a drug is introduced into healthy humansubjects or patients with the target disease or conditionand tested for safety,dosage tolerance,absorption,metabolism,distribution,excretion,and if possible,togain an early indication of its effectiveness“phase 2 clinical tr

310、ial”a study in which a drug is administered to a limitedpatient population to identify possible adverse effects andsafety risks,to preliminarily evaluate the efficacy of theproduct for specific targeted diseases,and to determinedosage tolerance and optimal dosage“phase 3 clinical trial”a study in wh

311、ich a drug is administered to an expandedpatient population generally at geographically dispersedclinical trial sites,in well-controlled clinical trials togenerate enough data to statistically evaluate the efficacyand safety of the product for approval,to provideadequate information for the labeling

312、 of the product“pharmacokinetics”or“PK”a measurement of how fast and how completely the drugisabsorbedintoanimalorhumanbody,andthedistribution,metabolism,and excretion of drugs inanimal or human body“pivotal trial”a clinical trial or study to demonstrate clinical efficacyand safety evidence required

313、 before submission for drugmarketing approvalGLOSSARY OF TECHNICAL TERMS 41 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“platinum-based chemotherapy”chemotherapy cont

314、aining platinum complexes,which isused to treat multiple types of cancers“pMMR”proficient mismatch repair“PR”partial response,referring to an at least 30%but below100%decrease in the size of a tumor or in the extent ofcancer in the body in response to treatment,according toRECIST“Q2W”and“Q3W”dosing

315、frequency,referring to“once every two weeks”and“once every three weeks,”respectively“QMS”quality management system“RECIST”Response Evaluation Criteria in Solid Tumors,a set ofpublished rules that define when tumors in cancerpatientsimprove(“respond”),staythesame(“stabilize”),or worsen(“progress”)dur

316、ing treatment.The criteria were published in February 2000 by aninternationalcollaborationincludingtheEuropeanOrganization for Research and Treatment of Cancer,National Cancer Institute of the United States,and theNational Cancer Institute of Canada Clinical TrialsGroup.Now the majority of clinical

317、trials worldwideevaluating cancer treatments for objective response insolid tumors use RECIST.These criteria were developedandpublishedinFebruary2000,andsubsequentlyupdated in 2009“RET”rearranged during transfection,a proto-oncogene,i.e.,agene that promotes cancer formation when altered bymutations

318、or rearrangements“RP2D”recommended phase 2 dose,usually the highest dose withacceptable toxicity,usually defined as the dose levelproducing around 20%of DLTGLOSSARY OF TECHNICAL TERMS 42 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTI

319、ON WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“SAE”serious adverse event,any medical occurrence in humandrug trials that at any dose:results in death;is life-threatening;requires inpatient hospitalization or causesprolongationofexistinghospitalization;resultsinpersistent or signif

320、icant disability/incapacity;may havecaused a congenital anomaly/birth defect,or requiresintervention to prevent permanent impairment or damage“SCLC”small-cell lung cancer“second-line”or“2L”with respect to any disease,the therapy or therapies thatare given when initial treatments(first-line therapy)d

321、onot work,or stop working“SIRP?”signal regulatory protein?,a regulatory membraneglycoprotein from SIRP family expressed mainly bymyeloid cells and also by stem cells or neuron“solid tumors”an abnormal mass of tissue that usually does not containcysts or liquid areas.Solid tumors may be benign(notcan

322、cer),or malignant(cancer).Different types of solidtumors are named for the type of cells that form them.Examples of solid tumors are carcinomas(cancers thatbegin in the lining layer(epithelial cells)of organs)andlymphomas(cancers that begin in lymphocytes wherelymphomas occur when lymphocytes change

323、 and growout of control)“stable disease”in oncology,it refers to cancer that is neither decreasingat least 30%nor increasing at least 20%in the size of atumor or in the extent of cancer in the body in responseto treatment,according to RECIST“standard-of-care”or“SoC”treatment that is accepted by medi

324、cal experts as a propertreatment for a certain type of disease and that is widelyused by healthcare professionals“STS”soft tissue sarcoma“targeted therapy”a major type of treatment modalities that works bytargeting a particular molecule or molecules implicated inor essential to the pathogenesis of c

325、ancer and non-oncology indications,including but not limited to smallmolecule drugs and monoclonal antibodiesGLOSSARY OF TECHNICAL TERMS 43 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER

326、 OF THIS DOCUMENT.“T cell”a lymphocyte of a type produced or processed by thethymus gland and actively participating in the immuneresponse,which plays a central role in cell-mediatedimmunity.T cells can be distinguished from otherlymphocytes,such as B cells and NK cells,by thepresence of a T cell re

327、ceptor on the cell surface“TAA”tumor-associated antigen,an antigen with elevated levelon tumor cells and lower levels on normal cells“TAM”tumor-associated macrophage“TCPP”target candidate product profile“TEAE”treatment-emergent adverse event,either an adverseeventwithonsetaftertheinitiationofthestud

328、ymedication or an adverse event with onset before studymedication that worsened in severity after the initiationof study medication“TGF”transforming growth factor-“third-line”or“3L”with respect to any disease,the therapy or therapies thatare given when both initial treatment(first-line therapy)and s

329、ubsequent treatment(second-line therapy)do notwork,or stop working“TIL”tumor-infiltrating lymphocyte“TME”tumor microenvironment“Treg cells”regulatory T cells,that are a specialized subpopulation ofT-cells which have a role in regulating or suppressingother cells in the immune system.Tregs control th

330、eimmuneresponsetoantigensandhelppreventautoimmune disease“TRAE”treatment-related adverse event,which is an adverseevent that in the investigators opinion may have beencausedbythestudymedicationwithreasonablepossibility“TRK”tropomyosin related kinaseGLOSSARY OF TECHNICAL TERMS 44 THIS DOCUMENT IS IN

331、DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.“TTF”time to treatment failure“VEGF”vascularendothelialgrowthfactor,aproteinthatstimulates the formation of blood vessels“WHO”World Health Org

332、anizationGLOSSARY OF TECHNICAL TERMS 45 THIS DOCUMENT IS IN DRAFT FORM,INCOMPLETE AND SUBJECT TO CHANGE AND THAT THE INFORMATION MUSTBE READ IN CONJUNCTION WITH THE SECTION HEADED“WARNING”ON THE COVER OF THIS DOCUMENT.This document contains certain forward-looking statements and information relating

333、 to usand our subsidiaries that are based on the beliefs of our management as well as assumptionsmade by and information currently available to our management.When used in this document,the words“aim,”“anticipate,”“believe,”“could,”“estimate,”“expect,”“going forward,”“intend,”“may,”“might,”“ought to,”“plan,”“potential,”“predict,”“project,”“seek,”“should,”“will,”“would”and the negative of these wor