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1、F-1/A 1 ff12023a1_jyongbio.htm REGISTRATION STATEMENTAs filed with the Securities and Exchange Commission on October 18,2023Registration Statement No.333-274042UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON,D.C.20549_AMENDMENT NO.1 TOFORM F-1REGISTRATION STATEMENTUNDERTHE SECURITIES ACT O

2、F 1933_Jyong Biotech Ltd.(Exact name of Registrant as specified in its charter)_Not Applicable(Translation of Registrants name into English)Cayman Islands 2834 Not Applicable(State or otherjurisdiction ofincorporation ororganization)(Primary StandardIndustrialClassification CodeNumber)(I.R.S.Employe

3、rIdentification Number)23F-3,No.95,Section1,Xintai 5th Road,Xizhi District,New Taipei City,Taiwan,221Tel:+886-2-2732-5205(Address,includingzipcode,andtelephonenumber,includingareacode,ofRegistrantsprinci_Cogency Global Inc.122 East 42nd Street,18th FloorNew York,NY 10168+1(800)221-0102(Name,address,

4、including zip code,and telephone number,including areacode,of agent for service)_Copies to:Yang Ge,Esq.DLA Piper UK LLP20th Floor,South Tower,KerryCenterNo.1 Guanghua Road,ChaoyangDistrictBeijing,China 100020Tel:+86-10-8520-0616 Fang Liu,Esq.VCL Law LLP1945 Old Gallows Road,Suite 630Vienna,VA22182Te

5、l:+1 703-919-7285_Approximate date of commencement of proposed sale to the public:as soon aspracticable after the effective date of this registration statement.If any of the securities being registered on this Form are to be offered on a delayed orcontinuous basis pursuant to Rule415 under the Secur

6、ities Actof1933,check the following box.If this Form is filed to register additional securities for an offering pursuant toRule462(b)under the Securities Act,check the following box and list the Securities Actregistration statement number of the earlier effective registration statement for the same

7、offering.If this Form is a post-effective amendment filed pursuant to Rule462(c)under theSecurities Act,check the following box and list the Securities Act registration statement number ofthe earlier effective registration statement for the same offering.If this Form is a post-effective amendment fi

8、led pursuant to Rule462(d)under theSecurities Act,check the following box and list the Securities Act registration statement number ofthe earlier effective registration statement for the same offering.Indicate by check mark whether the registrant is an emerging growth company as defined inRule405 of

9、 the Securities Act of 1933.Emerging growth company If an emerging growth company that prepares its financial statements in accordance withU.S.GAAP,indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting

10、 standards provided pursuant toSection7(a)(2)(B)of the Securities Act._The term“new or revised financial accounting standard”refers to any update issued by theFinancial Accounting Standards Board to its Accounting Standards Codification after April5,2012.The Registrant hereby amends this Registratio

11、n Statement on such date or dates asmay be necessary to delay its effective date until the Registrant shall file afurther amendment which specifically states that this Registration Statement shallthereafter become effective in accordance with Section8(a)of the SecuritiesActof1933,as amended,or until

12、 the Registration Statement shall become effectiveon such date as the Securities and Exchange Commission,acting pursuant to suchSection8(a),may determine.Table of ContentsThe information in this preliminary prospectus is not complete and may be changed.These securities may not be sold until the regi

13、stration statement filed with theSecurities and Exchange Commission is effective.This preliminary prospectus is notan offer to sell nor does it seek an offer to buy these securities in anyjurisdiction where the offer or sale is not permitted.PRELIMINARY PROSPECTUS(Subject to Completion)Dated,2023Jyo

14、ng Biotech Ltd.Ordinary SharesThis is an initial public offering of ordinary shares of Jyong BiotechLtd.,par value US$0.00001 per share,by Jyong Biotech Ltd.We currently anticipate the initial public offering price of our ordinary shares,will be between US$and US$per ordinary share.Prior to thisoffe

15、ring,there is no public market for our ordinary shares.We have applied to list the ordinary shares on the Nasdaq Capital Market underthe symbol“JYB.”We cannot assure you that our application will be approved;however,if it is not approved,we will not complete this offering.We are an“emerging growth c

16、ompany”and a“foreign private issuer”underapplicable U.S.federal securities laws,and as such,are eligible for certainreduced public company reporting requirements for this prospectus and future filings.See the sections titled“Prospectus SummaryImplications of Being an EmergingGrowth Company”and“Prosp

17、ectus SummaryImplications of Being a Foreign PrivateIssuer”for additional information.We are a Cayman Islands exempted holding company with operations conducted by oursubsidiaries.Throughout this prospectus,unless the context indicates otherwise,references to“the Company,”“our Company,”and“Jyong”ref

18、er to Jyong BiotechLtd.“We,”“us,”and“our”refer to Jyong Biotech Ltd.and its subsidiaries.Wecurrently conduct our business through five wholly owned subsidiaries,includingHealth Ever Bio-Tech Co.,Ltd.and Genvace Biotechnology Co.,Ltd.in Taiwan,JyongBiotech International Pte.Ltd.in Singapore,Top ShunX

19、ing Bio-Tech Co.,Limited inHongKong,and Innovative Biotech Co.,Ltd.in the Peoples Republic of China,orthe PRC,among which Jyong holds the equity interests in its PRC subsidiary throughits subsidiary incorporated in HongKong.See“Corporate History and Structure”foradditional details.Investors purchasi

20、ng our ordinary shares in this initial publicoffering are purchasing equity securities of our Cayman Islands exempted holdingcompany and are not purchasing equity securities of our operating subsidiaries.Inthe normal course of our business,we would evaluate the financial condition andcapital needs o

21、f our subsidiaries periodically and then provide funding for theiroperations via equity investments and intercompany loans.As of the date of thisprospectus,we have provided US$14.5 million intercompany loans and US$5,000 capitalcontributions to our Hong Kong subsidiary.None of our subsidiaries have

22、declared orpaid any dividends or distributions on equity to their respective holding companiesas of the date of this prospectus.We have largely relied,and expect to continuouslyrely,on dividends or other distributions on equity from our subsidiaries for ourcash requirements.We have no plans to decla

23、re cash dividends in the near term,butas a holding company,we may depend on receipt of funds from one or more of oursubsidiaries if we determine to pay cash dividends to holders of our ordinary sharesin the future.While our PRC subsidiary has no operations and generates no revenue asof the date of t

24、his prospectus,should it generate revenue in the future,restrictions on currency exchanges in China may limit our ability to freely convertsuch Renminbi to fund any future business activities outside China or other paymentsin U.S.dollars,and capital control measures imposed by the Chinese government

25、 maylimit our ability to use capital from our PRC subsidiary for business purposesoutside of China.See“Prospectus SummaryHolding Company Structure”on page 3for a more detailed description.As of the date of this prospectus,all of our operations are outside of PRC,although we have established one subs

26、idiary in HongKong and one subsidiary inChina.We do not expect the listing of our ordinary shares to be materially affectedby recent statements by the PRC government indicating an intent to exert moreoversight and control over offerings that are conducted overseas and/or foreigninvestment in China-b

27、ased issuers,including but not limited to,the cybersecurityreview,the merger control review and other regulatory reviews of overseas listingthrough an offshore holding company.Specifically,on February 17,2023,the ChinaSecurities Regulatory Commission,or CSRC,issued the Trial Administrative Measureso

28、f Overseas Securities Offering and Listing by Domestic Companies,or the TrialMeasures,which became effective on March 31,2023.We reasonably believed that theTrial Measures do not apply to us,and as of the date of this prospectus,we have notreceived any inquiry,notice,warning or sanctions regarding o

29、ur planned overseaslisting from the CSRC and any other PRC governmental authorities.However,due to theextraterritorial reach,the so-called“long arm provisions”under the current PRClaws and regulations,there remains regulatory uncertainty with respect to theimplementation and interpretation of laws i

30、n China.See“Risk FactorsRisksRelated to Our Business and Industry We currently have no operations in Chinaalthough we have established a subsidiary in each of HongKong and China.However,due to the extraterritorial reach(the so-called“long arm provisions”)under thecurrent PRC laws and regulations,the

31、 Chinese government may exert substantialoversight and influence over the manner in which we must conduct our business and mayintervene in or influence our operations at any time,which could result in amaterial change in our operations and significantly and adversely impact the value ofour ordinary

32、shares”on page 45 for more details.Table of ContentsThe information in this preliminary prospectus is not complete and may be changed.These securities may not be sold until the registration statement filed with theSecurities and Exchange Commission is effective.This preliminary prospectus is notan o

33、ffer to sell nor does it seek an offer to buy these securities in anyjurisdiction where the offer or sale is not permitted.In the event that we elect to expand our operations into China in the future(see“BusinessOur Strategies”beginning on page103 for our strategies for futuredevelopment),there may

34、be certain legal and operational risks associated with havingcertain operations in China,including that changes in the legal,political andeconomic policies of the Chinese government,the relations between China and theUnitedStates,or Chinese or UnitedStates regulations may materially and adverselyaff

35、ect our business,financial condition,results of operations and the market priceof our ordinary shares.Any such changes may significantly limit or completely hinderour ability to offer or continue to offer our ordinary shares to investors,and maycause the value of our ordinary shares to significantly

36、 decline or become worthless.For more information on these risks and other risks you should consider before buyingour ordinary shares,see“Risk FactorsRisks Related to Our Business andIndustry Changes in the political and economic policies of the Chinese governmentor in relations between China and th

37、e UnitedStates may materially and adverselyaffect our business,financial condition,results of operations and the market priceof our ordinary shares”on page 45 for more details.Furthermore,as more stringent criteria,including the Holding Foreign CompaniesAccountable Act,or the HFCAA,have been imposed

38、 by the SEC and the Public CompanyAccounting Oversight Board,or the PCAOB,recently,our ordinary shares may beprohibited from trading in the UnitedStates if our auditor cannot be fullyinspected.On June 22,2021,United States Senate has passed the Accelerating HoldingForeign Companies Accountable Act,o

39、r the Accelerating HFCAA,which was signed intolaw on December 29,2022,amending the HFCAA and requiring the SEC to prohibit anissuers securities from trading on any U.S.stock exchange if its auditor is notsubject to PCAOB inspections for two consecutive years instead of three consecutiveyears.On Dece

40、mber 16,2021,the PCAOB issued a report on its determinations that itis unable to inspect or investigate completely PCAOB-registered public accountingfirms headquartered in mainland China and in Hong Kong because of positions taken byPRC authorities in those jurisdictions.On August 26,2022,the PCAOB

41、signed aStatement of Protocol with the China Securities Regulatory Commission and the PRCMinistry of Finance which was the first step toward opening access for the PCAOB toinspect and investigate registered public accounting firms headquartered in mainlandChina and Hong Kong completely.On December 1

42、5,2022,the PCAOB announced that it wasable to secure complete access to inspect and investigate PCAOB-registered publicaccounting firms headquartered in mainland China and Hong Kong completely in 2022.The PCAOB Board vacated its previous 2021 determinations that the PCAOB was unable toinspect or inv

43、estigate completely registered public accounting firms headquartered inmainland China and Hong Kong.However,whether the PCAOB will continue to be able tosatisfactorily conduct inspections of PCAOB-registered public accounting firmsheadquartered in mainland China and Hong Kong is subject to uncertain

44、ties and dependson a number of factors out of our and our auditors control.The PCAOB continues todemand complete access in mainland China and Hong Kong moving forward and is makingplans to resume regular inspections in early 2023 and beyond,as well as to continuepursuing ongoing investigations and i

45、nitiate new investigations as needed.The PCAOBhas also indicated that it will act immediately to consider the need to issue newdeterminations with the HFCAA if needed.Our auditor,WWC,P.C.,headquartered in SanMateo,California,and our predecessor auditor,Marcum Asia CPAs LLP based inNewYork,are curren

46、tly subject to inspection by the PCAOB on a regular basis.Therefore,we believe that,as of the date of this prospectus,our auditor is notsubject to the determinations announced by the PCAOB on December16,2021.For more information on these risks and other risks you should consider beforebuying our ord

47、inary shares,see“Risk Factors”beginning on page 12.We cannotassure you whether Nasdaq or other regulatory authorities will apply additional ormore stringent criteria to us.Such uncertainty could cause the market price of ourordinary shares to be materially and adversely affected._PRICE US$PER SHARE_

48、 Perordinaryshare TotalPublic offering price US$US$Underwriting discounts and commissions(1)(2)US$US$Proceeds,before expenses,to us US$US$_(1)For a description of compensation payable to the underwriters,see“Underwriting.”(2)Represents underwriting discounts up to seven percent(7.0%)(or$per ordinary

49、share),of gross proceeds of this offering.Does not include a non-accountable expenseallowance.See“Underwriting”for all compensation to be paid to the underwriters.The underwriters have a 45-day option to purchase up to an additional ordinary shares from us at the initial public offeringprice less th

50、e underwriting discounts and commissions.The Securities and Exchange Commission and state securities regulatorshave not approved or disapproved of these securities,or determined if thisprospectus is truthful or complete.Any representation to the contrary is acriminal offense.The underwriters expect

51、to deliver the ordinary shares against payment inU.S.dollars in NewYork,NY on,2023._Joseph Stone Capital,LLC_The date of this prospectus is,2023 Table of ContentsTABLE OF CONTENTS PagePROSPECTUS SUMMARY 1THE OFFERING 10RISK FACTORS 12SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DAT

52、A 65USE OF PROCEEDS 66DIVIDEND POLICY 67CAPITALIZATION 68DILUTION 69ENFORCEMENT OF CIVIL LIABILITIES 71CORPORATE HISTORY AND STRUCTURE 73MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION ANDRESULTS OF OPERATIONS 75INDUSTRY OVERVIEW 93BUSINESS 99REGULATIONS 126MANAGEMENT 155PRINCIPAL SHAREHO

53、LDERS 160RELATED PARTY TRANSACTIONS 162DESCRIPTION OF SHARE CAPITAL 164SHARES ELIGIBLE FOR FUTURE SALE 172TAXATION 174UNDERWRITING 179EXPENSES RELATED TO THIS OFFERING 183LEGAL MATTERS 184EXPERTS 184CHANGE IN REGISTRANTS CERTIFYING ACCOUNTANT 184WHERE YOU CAN FIND ADDITIONAL INFORMATION 185INDEX TO

54、CONSOLIDATED FINANCIAL STATEMENTS F-1No dealer,salesperson or other person is authorized to give anyinformation or to represent anything not contained in this prospectus or inany free writing prospectus we may authorize to be delivered or madeavailable to you.You must not rely on any unauthorized in

55、formation orrepresentations.This prospectus is an offer to sell only the ordinaryshares offered hereby,but only under circumstances and in jurisdictionswhere it is lawful to do so.The information contained in this prospectusis current only as of the date of this prospectus,regardless of the timeof d

56、elivery of this prospectus or of any sale of the ordinary shares.Neither we nor any of the underwriters have done anything that would permit thisoffering or possession or distribution of this prospectus or any filed free writingprospectus in any jurisdiction where action for that purpose is required

57、,other thanin the UnitedStates.Persons outside the UnitedStates who come into possession ofthis prospectus or any filed free writing prospectus must inform themselves about,and observe any restrictions relating to,the offering of the ordinary shares and thedistribution of this prospectus or any file

58、d free writing prospectus outside of theUnitedStates.Until,2023(the 25thday after the date of this prospectus),all dealersthat buy,sell or trade ordinary shares,whether or not participating in thisoffering,may be required to deliver a prospectus.This is in addition to theobligation of dealers to del

59、iver a prospectus when acting as underwriters and withrespect to their unsold allotments or subscriptions.iTable of ContentsPROSPECTUS SUMMARYThe following summary is qualified in its entirety by,and should be read inconjunction with,the more detailed information and financial statements appearingel

60、sewhere in this prospectus.In addition to this summary,we urge you to read theentire prospectus carefully,especially the risks of investing in our ordinaryshares discussed under“Risk Factors”and information contained in“ManagementsDiscussion and Analysis of Financial Condition and Results of Operati

61、ons”beforedeciding whether to buy our ordinary shares.In addition,this prospectus containsinformation from a report prepared by Frost&Sullivan Limited,or Frost&Sullivan,a third-party market research firm.Frost&Sullivan was commissioned byus to provide information on the pharmaceutical industry.OUR M

62、ISSIONWe endeavor to create value by supplying unique,first-class innovative drugs,which are effective and safe for our customers health.We pursue to be a valuablebusiness organization held in high esteem by the people.OVERVIEWWe are a science-driven biotechnology company based in Taiwan and are com

63、mittedto developing and commercializing innovative and differentiated new drugs(plant-derived)mainly specializing in the treatment of urinary system diseases,with aninitial focus on the markets of the U.S.,the EU and Asia(primarily Taiwan andmainland China).Since our inception in 2002,we have been d

64、edicated to the research anddevelopment of new drugs with high safety and efficacy.Through 20years ofefforts,we have built integrated capabilities that encompass all keyfunctionalities of drug development,including early-stage drug discovery anddevelopment,clinical trials,regulatory affairs,manufact

65、uring andcommercialization.Leveraging our strong research and development capabilities andproprietary platform,we have been developing a series of drug candidates,including one core drug candidate at NDA stage,one clinical-stage key drugcandidate and other preclinical-stage drug candidates.Among our

66、 drug candidates,we have filed the new drug application,or NDA,for MCS-2 in the U.S.One of ourclinical-stage key drug candidates,PCP,is under phaseII trials stage in Taiwan.Another preclinical-stage key drug candidate,IC,is under preclinical studies.The following chart illustrates and summarizes the

67、 development status of thepipeline of our drug candidates as of the date of this prospectus:Our pipeline features three innovative and differentiated new drug candidates,and we are developing them for(i)the treatment of benign prostatehyperplasia/lower urinary tract symptoms,or BPH/LUTS,(ii)prostate

68、 cancerprevention,and(iii)the treatment of interstitial cystitis,respectively.MCS-2:MCS-2 is our new drug candidate developed for unmet medicalneeds of BPH/LUTS treatment.MCS-2 is expected to be our core product inthe future.MCS-2 is a softgel containing patented active pharmaceuticalingredients of

69、carotenoid with chylomicron technology.The activeconstituents in MCS-2 are carotenoids,the essential and lipid-solublecomponent of photosynthetic organisms extracted from plants with eminentphotoprotective and antioxidant properties,and we have further developedMCS-2 formulation using chylomicron te

70、chnology to improve thebioavailability in MCS-2.Chylomicron is a type of lipoprotein particlesconsisting of triglycerides and phospholipids in human body.MCS-2 has apowerful1Table of Contentsantioxidant capacity and can reduce inflammatory cytokines.It takeseffect by reducing oxidative stress and in

71、flammation and has a dose-response effect.We have completed the four phaseIII clinical trials forMCS-2 in the U.S.and Taiwan,including two pivotal trials and two open-label extension study trials.The pooled study results of our phaseIIIclinical trials on MCS-2 show that the primary endpoint(namely,t

72、hechange in the total scores derived from the International Prostate SymptomScore system,orI-PSS,which is a validated,reproducible scoring systemthat measures severity of lower urinary tract symptoms and responses totherapeutics)has reached statistical significance and exhibited safetyprofile.We sub

73、mitted a new drug application of MCS-2 using ActivePharmaceutical Ingredient-1,or API-1,to the U.S.FDA in December 2021and received a filing confirmation letter from U.S.FDA on February 22,2022.However,after reviewing our application materials,the U.S.FDA hassuggested that we identify an additional

74、source for API-1,in case of ashort supply of API-1.We have been conducting due research anddevelopment and identified Active Pharmaceutical Ingredient-2,or API-2.API-1 and API-2 have the same composition and are covered by the samepatent owned by us;however,they are sourced from raw materialsmanufac

75、tured in different locations.We voluntarily withdrew our NDA onNovember 30,2022,in order to provide more information about API-2 forthe U.S.FDAs review,and we received the Acknowledge Withdrawal fromthe U.S.FDA on December 12,2022.In the Acknowledge Withdrawal,the U.S.FDA clearly stated that“this wi

76、thdrawal will not prejudice any futuredecisions on filing”if we decide to resubmit our NDA,and we can retainthe application number(NDA 212872).We submitted the preliminarycomparative data of API-1 and API-2 for the U.S.FDAs review andreceived feedbacks from the U.S.FDA in June 2023.In the feedbacks,

77、theU.S.FDA suggested that we conduct additional tests before they are ableto evaluate and accept our proposed specifications for both API-1 and API-2.We will submit the relevant study data to the U.S.FDA once the data isavailable.The supplier of API-1 sold a parcel of its land and is in theprocess o

78、f relocating and reconstructing its manufacturing facility,andas a result,the supplier of API-1 withdrew the drug master file,adocument required in our NDA,from the U.S.FDA.We are currentlypreparing an updated drug master file using API-2.We plan to resubmit ourNDA under the same NDA number to the U

79、.S.FDA by the end of 2024 once alldata and information requested by the U.S.FDA is available.BPH/LUTS isthe most common urinary tract disease in the middle-aged male population.According to Frost&Sullivan,the global prevalence of BPH increasedfrom 88.4million in 2017 to 94.2million in 2020,represent

80、ing anincrease of 6.5%.The global BPH drugs market increased fromUS$3.7billion in 2017 to US$4.1billion in 2020,representing a CAGR of4.6%.We are establishing a strong sales and marketing team that isexpected to consist of employees with rich experience in relevant areasand our target markets,and pl

81、an to work with both domestic andinternational business partners to seize the great market opportunitiesand to help more patients reduce their distress caused by BPH/LUTS anddrug side effects caused by chemical drugs.PCP:PCP is our key new drug candidate developed for theprevention of prostate cance

82、r.Similar to MCS-2,PCP works through itsmechanism of antioxidant and anti-inflammatory.PCP contains several typesof patented active pharmaceutical ingredients of carotenoid withchylomicron technology that reduce oxidative stress and inflammatorycytokines(IL-6),both of which are main causes of many c

83、hronicinflammatory diseases.The active constituents in PCP are carotenoids.PCPand MCS-2 are essentially the same in terms of composition of activeingredients,dosage form,strength and route of administration;however,they are different drug candidates targeting different indications.We areconducting p

84、haseII clinical trials of PCP in Taiwan.Prostate cancerbegins when cells in the prostate gland start to grow out of control.Ingeneral,the more quickly prostate cells grow and divide,the more chancesthere are for mutations to occur.According to Frost&Sullivan,theglobal prevalence of prostate cancer i

85、ncreased from 10.0million in 2017to 11.2million in 2020,representing a CAGR of 3.9%.The global prostatecancer market increased from US$9.7billion in 2017 to US$12.6billion in2019,representing a CAGR of 9.1%.In addition,the prostate-specificantigen abnormal population,or PSA abnormal population,repre

86、senting menover 40years old with a prostate-specific antigen test value of 4.0ng/ml or higher,is exposed to a high risk of prostate cancer.From 2015to 2020,the total number of PSA abnormal populations in the U.S.,Taiwanand China increased from 5.0million to 5.3million.IC:IC is our additional key new

87、 drug candidate which is composedof polysorbate loaded micelles as nanocarriers which can be used in theintravenous injection and intravesical instillation.The micelles enhancethe bioavailability by prolonging the duration of stay in the bladder andincrease the penetration of drug across the bladder

88、 wall.IC/BPS,refersto a bladder pain disorder that is often associated with voidingsymptomatology and other systemic chronic pain disorders.We incurred research and development expenses of approximately US$1.6 million,US$1.3 million,US$0.7 million and US$0.5 million for the years ended December31,20

89、21 and 2022 and the six months ended June 30,2022 and 2023,respectively.2Table of ContentsOUR STRENGTHSWe believe the following strengths have contributed to our success anddifferentiate us from others:Innovative new drug candidate developed for BPH/LUTS with excellenttolerability;Diverse drug portf

90、olio and pipeline drug candidates focusing on thetreatment of urinary system diseases;Leading R&D capabilities and proprietary platform for innovative drugs;Integrated in-house capabilities that well position us for pharmaceuticalinnovation from bench to bedside;andVisionary and experienced manageme

91、nt and R&D team with extensive industryexpertise.OUR STRATEGIESWe aim to execute the following business strategies:Advance the clinical development of our core drug candidate MCS-2 to seekregulatory approval and achieve commercialization in our target markets;Leverage differentiated approaches to ad

92、vance our development of otherdrug candidates,such as PCP,IC and other new small molecule drugs,toward regulatory approvals;Establish and enhance integrated launch capabilities and strategicallybuild commercial infrastructure customized to each of our drug candidates;andContinue to deepen our pipeli

93、ne in existing therapeutic areas with newdrugs that fit with our expertise,portfolio and strategy.CORPORATE STRUCTUREOur Corporate StructureThe following diagram sets forth our corporate structure prior to the initialoffering:_(1)No single shareholder among“other shareholders”beneficially owns more

94、than 5%of ourordinary shares.Holding Company StructureWe are a holding company with no business operations of our own and asubstantial portion of our assets are located in Taiwan.We conduct all of ouroperations through our five wholly owned subsidiaries,including Health Ever Bio-Tech Co.,Ltd.and Gen

95、vace Biotechnology Co.,Ltd.in Taiwan,Jyong BiotechInternational Pte.Ltd.in Singapore,Top ShunXing Bio-Tech Co.,Limited in HongKong,and Innovative Biotech Co.,Ltd.in the PRC,among which3Table of ContentsJyong holds the equity interests in its PRC subsidiary through its subsidiaryincorporated in Hong

96、Kong.As a result,our ability to pay dividends and to serviceany debt we may incur overseas largely depends upon dividends paid by oursubsidiaries.If our subsidiaries incur debt on their own behalf in the future,theinstruments governing their debt may restrict their ability to pay dividends to us.Jyo

97、ng is not prohibited under the laws of the Cayman Islands to provide fundingto our subsidiaries through capital contributions or loans,and there are currentlyno restrictions on transferring funds between our Cayman Islands holding companyand subsidiaries in Singapore and HongKong.Our ability to make

98、 loans andadditional capital contribution to our Taiwan and PRC subsidiaries might berestricted by Taiwan and PRC laws and regulations.In the normal course of our business,Jyong would evaluate the financialcondition and capital needs of our subsidiaries periodically and then providefunding for their

99、 operations via equity investments and intercompany loans.As ofJune 30,2023,we have provided US$14.5million to our HongKong subsidiary foracquiring the patent owned by our Taiwan subsidiary via intercompany loans,and wehave also provided US$5,000 to our HongKong subsidiary via capital contribution.O

100、ur HongKong subsidiary borrowed approximately US$2.4million from third partiesto invest our PRC subsidiary via capital contribution.No other transfer of cash orother types of assets has been made between our Cayman Islands holding company andsubsidiaries as of the date of this prospectus.Our subsidi

101、aries outside China and Taiwan are permitted,under the respectivelaws of Singapore and HongKong,to provide funding to Jyong through dividenddistribution without restrictions on the amount of the funds.Under Taiwan laws andregulations,there are no restrictions on providing funding to Jyong throughdiv

102、idend distribution except for the withholding tax.Pursuant to the Taiwan IncomeTax Act,a withholding tax rate of up to 21%will be applicable to dividendspayable by Taiwanese companies to non-Taiwan-resident enterprises.Our PRCsubsidiary has no operations and generates no revenue as of the date of th

103、isprospectus,but should it generate revenue in the future,its ability to distributedividends to us will be limited by foreign exchange restrictions.In addition,restrictions on currency exchanges in China may limit our ability to freely convertRenminbi to fund any future business activities outside C

104、hina or other payments inU.S.dollars,and capital control measures imposed by the Chinese government maylimit our ability to use capital from our PRC subsidiary for business purposesoutside of China.Under existing PRC foreign exchange regulations,payments ofcurrent account items,including profit dist

105、ributions,interest payments and tradeand service-related foreign exchange transactions,cannot be made in currenciesother than Renminbi without complying with certain procedural requirements of theState Administration of Foreign Exchange,or SAFE.Specifically,approval from orregistration with appropri

106、ate government authorities is required where Renminbi isto be converted into another currency and remitted out of China to pay capitalexpenses,such as the repayment of loans denominated in currencies other thanRenminbi.As a result,we may need to obtain SAFE approval to use cash generatedfrom the ope

107、rations of our PRC subsidiary to pay off its debt in a currency otherthan Renminbi owed to entities outside China,or to make other capital expenditurepayments outside China in a currency other than Renminbi.On the other hand,thePRC Enterprise Tax Law(“EIT Law”)and its implementation rules provide th

108、at awithholding tax rate of up to 10%will be applicable to dividends payable byChinese companies to non-PRC-resident enterprises unless otherwise exempted orreduced according to treaties or arrangements between the PRC central governmentand governments of other countries or regions where the non-PRC

109、-residententerprises are incorporated.As of the date of this prospectus,we have notreceived,nor do we have any present plan to receive dividends paid by ourSingapore,Taiwan,HongKong and PRC subsidiaries.As of the date of this prospectus,we did not adopt any specific cashmanagement policies and proce

110、dures in relation to how funds are transferredwithin/through our group.Our management monitors the cash position of each entitywithin our group regularly on a monthly basis.In the event that there is a needfor cash or a potential short-term cashflow shortage,it would be reported to ourchief financia

111、l officer and,subject to the approval by our board of directors,wewill enter into an intercompany loan arrangement for relevant subsidiary.Otherthan the above,we did not adopt or maintain any cash management policies andprocedures as of the date of this prospectus.Our Board of Directors has discreti

112、on as to whether to distribute dividends,subject to certain requirements of Cayman Islands law.As of the date of thisprospectus,we have not paid and do not have any present plan to declare or pay anydividends in the foreseeable future.We currently intend to retain most of ouravailable funds and any

113、future earnings to fund the development and growth of ourbusiness.See“Risk FactorsRisks Related to Our Ordinary Shares and ThisOfferingBecause we do not expect to pay dividends in the foreseeable futureafter this offering,you must rely on price appreciation of our ordinary shares forreturn on your i

114、nvestment.”4Table of ContentsCORPORATE INFORMATIONWe were incorporated on January26,2018 as an exempted company limited byshares under the laws of Cayman Islands.Our registered office is located at 4thFloor,Harbour Place,103 South Church Street,George Town,P.O.Box 10240,GrandCayman KY1 1002,Cayman I

115、slands.Our principal executive offices of our operating subsidiaries are located at23F-3,No.95,Section1,Xintai 5th Road,Xizhi District,New Taipei City,Taiwan,221.Our telephone number at this address is+886-2-2732-5205.Our agent for service of process in the UnitedStates is Cogency Global Inc.located

116、 at 122 East 42nd Street,18th Floor,New York,NY 10168.Investors should contact us for any inquiries through the address and telephonenumber of our principal executive office.Our principal website ishttps:/ information contained on our website is nota part of this prospectus.IMPLICATIONS OF BEING AN

117、EMERGING GROWTH COMPANYAs a company with less than US$1.235billion in revenue for our last fiscalyear,we qualify as an“emerging growth company”pursuant to the Jumpstart OurBusiness Startups Actof2012,as amended,or the JOBS Act.An emerging growthcompany may take advantage of specified reduced reporti

118、ng and other requirementscompared to those that are otherwise applicable generally to public companies.These provisions include exemption from the auditor attestation requirement underSection404 of the Sarbanes-Oxley Actof2002,or Section404,in the assessmentof the emerging growth companys internal c

119、ontrol over financial reporting.TheJOBS Act also provides that an emerging growth company does not need to comply withany new or revised financial accounting standards until such date that a privatecompany is otherwise required to comply with such new or revised accountingstandards.We have elected t

120、o take advantage of such exemptions.We will remain an emerging growth company until the earliest of(i)thelastday of the fiscal year during which we have total annual gross revenue of atleast US$1.235billion;(ii)the lastday of our fiscal year following the fifthanniversary of the completion of this o

121、ffering;(iii)the date on which we have,during the preceding three-year period,issued more than US$1.0billion in non-convertible debt;or(iv)the date on which we are deemed to be a“largeaccelerated filer”under the Securities ExchangeActof1934,as amended,or theExchangeAct,which would occur if the marke

122、t value of the ordinary shares that areheld by non-affiliates exceeds US$700million as of the last businessday of ourmost recently completed second fiscal quarter.Once we cease to be an emerginggrowth company,we will not be entitled to the exemptions provided in the JOBS Actdiscussed above.IMPLICATI

123、ONS OF BEING A FOREIGN PRIVATE ISSUERWe are also considered a“foreign private issuer.”Accordingly,uponconsummation of this offering,we will report under the ExchangeAct as a non-U.S.company with foreign private issuer status.This means that,even after we nolonger qualify as an emerging growth compan

124、y,as long as we qualify as a foreignprivate issuer under the ExchangeAct,we will be exempt from certain provisions ofthe ExchangeAct that are applicable to U.S.domestic public companies,including:the sections of the ExchangeAct regulating the solicitation of proxies,consents or authorizations in res

125、pect of a security registered under theExchangeAct;the sections of the ExchangeAct requiring insiders to file publicreports of their share ownership and trading activities and liability forinsiders who profit from trades made in a short period of time;andthe rules under the ExchangeAct requiring the

126、 filing with the SEC ofquarterly reports on Form10-Q containing unaudited financial and otherspecified information,or current reports on Form8-K,upon theoccurrence of specified significant events.We may take advantage of these exemptions until such time as we are no longer aforeign private issuer.We

127、 would cease to be a foreign private issuer at such timeas more than 50%of our outstanding voting securities are held by U.S.residentsand any of the following three circumstances applies:(i)the majority of ourexecutive officers or directors are U.S.citizens or residents,(ii)more than 50%of our asset

128、s are located in the UnitedStates or(iii)our business isadministered principally in the UnitedStates.5Table of ContentsIn this prospectus,we have taken advantage of certain of the reduced reportingrequirements as a result of being an emerging growth company and a foreign privateissuer.Accordingly,th

129、e information contained herein may be different than theinformation you receive from other public companies in which you hold equitysecurities.CONVENTIONS THAT APPLY TO THIS PROSPECTUSExcept otherwise indicated or the context otherwise requires:“CAGR”refers to compound average growth rate;“China”or

130、the“PRC”,in each case,refers to the Peoples Republic ofChina,excluding,for the purpose of this prospectus only,HongKong,Macau and Taiwan.The term“Chinese”has a correlative meaning for thepurpose of this prospectus.When used in the case of laws and regulations,of“China”or“the PRC”,it refers to only s

131、uch laws and regulations ofmainland China;“EIT”refers to enterprise income tax;“HongKong”refers to HongKong Special Administrative Region in thePRC;“HKD”refers to the legal currency of HongKong;“mu”refers to a Chinese unit of area,which equals to approximately666.7 square meters;“NTD”refers to the l

132、egal currency of Taiwan;“ordinary shares”or“shares”prior to the completion of this offeringrefer to our ordinary shares of par value US$0.00001 per share,and uponand after the completion of this offering are to our ordinary shares;“P value”refers to a statistical measurement used to validate ahypoth

133、esis against observed data.The lower the P value,the greater thestatistical significance of the observed difference.A P value of 0.05 orlower is generally considered statistically significant;“R&D”refers to research and development;“RMB”and“Renminbi”refer to the legal currency of China;“R value”refe

134、rs to the ratio of intrinsic clearance values of a probesubstrate for an enzymatic pathway in the absence of the potentialinducing drug versus in the presence of the potential inducing drug invitro drug-drug interaction study and was calculated using the followingequation:where d is a scaling factor

135、 that is assumed as 1;EC50 is the concentrationcausing half maximal effect;Emax is the maximum induction effect;I isthe concentration of BDS component D in serum;wD is the percentage ofcomponent D in BDS.“SEC”refers to the Securities and Exchange Commission;“TFDA”refers to the Food and Drug Administ

136、ration,Ministry of Healthand Welfare,the Republic of China;“US$”and“U.S.dollars”refer to the legal currency of theUnitedStates;“US FDA”refers to the U.S.Food and Drug Administration;“U.S.GAAP”refers to generally accepted accounting principles in theUnitedStates;and“we,”“us,”and“our”refer to Jyong Bi

137、otech Ltd.,a Cayman Islandscompany and its subsidiaries.Unless otherwise indicated,(a)information in this prospectus assumes thatthe underwriters do not exercise their over-allotment option to purchase additionalordinary shares,and(b)references in this prospectus to this offering are to ouroffering

138、of ordinary shares pursuant to this prospectus.6Table of ContentsOur reporting currency is U.S.dollars.The functional currency of theCompanys subsidiary located in Taiwan is NTD.Unless otherwise noted,alltranslations from NTD to U.S.dollars and from U.S.dollars to NTD in thisprospectus are made at a

139、 rate of NTD31.14 to US$1.00,the exchange rate in effectas of June 30,2023 as set forth in the H.10 statistical release of The Board ofGovernors of the Federal Reserve System.We make no representation that the NTD orU.S.dollar amounts referred to in this prospectus could have been or could beconvert

140、ed into U.S.dollars or NTD,as the case may be,at any particular rate orat all.Internet site addresses in this prospectus are included for reference only andthe information contained in any website,including our website,is notincorporated by reference into,and does not form part of,this prospectus.MA

141、RKET AND INDUSTRY DATAThis prospectus contains estimates and information concerning our industry,including our market position and the size and growth rates of the markets in whichwe participate,that are based on industry publications and the reports.Thisprospectus contains statistical data and esti

142、mates published by Frost&Sullivan,an independent research firm,for which we paid a fee.This information involves anumber of assumptions and limitations,and you are cautioned not to place unduereliance on these estimates.We have not independently verified the accuracy orcompleteness of the data conta

143、ined in these industry reports.The industry in whichwe operate is subject to a high degree of uncertainty and risk due to a variety offactors,including those described in the“Risk Factors”section.These and otherfactors could cause results to differ materially from those expressed in thesepublication

144、s and reports.Industry publications,research,surveys,studies and forecasts generally statethat the information they contain has been obtained from sources believed to bereliable but that the accuracy and completeness of such information are notguaranteed.Forecasts and other forward-looking informati

145、on obtained from thesesources are subject to the same qualifications and uncertainties as the otherforward-looking statements in this prospectus.These forecasts and forward-lookinginformation are subject to uncertainty and risk due to a variety of factors,including those described under“Risk Factors

146、.”These and other factors couldcause results to differ materially from those expressed in the forecasts orestimates from independent third parties and us.RISK FACTORS SUMMARYYou should carefully consider the risks and uncertainties summarized below,therisks described under the“Risk Factors”section b

147、eginning on page 12.The risksdescribed in“Risk Factors”in this prospectus may cause us to not realize thefull benefits of our strengths or may cause us to be unable to successfully executeall or part of our growth strategy.Some of the more significant risks include thefollowing:Our business is highl

148、y dependent on the success of our core drugcandidate,MCS-2.If we are unable to obtain marketing approval for orsuccessfully commercialize MCS-2,or if we experience significant delaysin doing so,our business could be adversely affected.(page 12)We may allocate our limited resources to pursue a partic

149、ular drugcandidate,indication,or technology and fail to capitalize on existing orfuture drug candidates,indications or technologies that may later proveto be more profitable,or for which there is a greater likelihood ofsuccess.(page 13)The COVID-19 pandemic and the monkeypox outbreak could adversely

150、 impactour business including our ongoing and planned clinical trials andpreclinical research.(page 13)Clinical development involves a lengthy and expensive process with anuncertain outcome,and results of earlier studies may not be predictive offuture study results.(page 15)All of our key drug candi

151、dates are in preclinical or clinical development.If we are unable to complete clinical development and obtain regulatoryapproval to ultimately commercialize our key drug candidates,or if weexperience significant delays in doing so,our business,financialcondition,results of operations and prospects w

152、ill be materially harmed.(page 16)7Table of ContentsIf we encounter delays or difficulties enrolling and retaining patients inour clinical trials,our clinical development progress and our receipt ofnecessary regulatory approvals could be delayed or otherwise adverselyaffected.(page 17)If clinical tr

153、ials of our key drug candidates fail to demonstrate safetyand efficacy to the satisfaction of regulatory authorities or do nototherwise produce positive results,we may incur additional costs orexperience delays in completing,or ultimately be unable to complete,thedevelopment and commercialization of

154、 our drug candidates.(page 19)Our clinical trials are conducted in multiple jurisdictions,which maysubject us to delays and expenses.(page 20)Our drug candidates may cause serious adverse,undesirable or unacceptableside effects or have other properties that could delay or prevent theirregulatory app

155、roval,limit the commercial profile of an approved label,and/or result in significant negative consequences following regulatoryapproval,if any.(page 20)The manufacture of our drug products is a complex process which requiressignificant expertise and capital investment,and if we encounter problemsin

156、establishing our manufacturing capabilities for clinical or commercialscale or in the manufacture of our future products,our business couldsuffer.(page 21)Changes in our drug candidates manufacturing or formulation may resultin additional costs or delay.(page 21)We have not yet obtained marketing ap

157、proval for a drug candidate and wemay be unable to obtain,or may be delayed in obtaining,marketingapproval for our drug candidates.(page 22)Obtaining and maintaining regulatory approval of our drug candidates inone jurisdiction does not mean that we will be successful in obtaining ormaintaining regu

158、latory approval of our drug candidates in otherjurisdictions.(page 22)Even if any of our drug candidates receives marketing approval,we orothers may later discover that the product is less effective thanpreviously believed or causes undesirable side effects that were notpreviously identified,which c

159、ould compromise our ability,or that of anyfuture collaborators,to market the product.(page 22)Our drug candidates may fail to achieve the degree of market acceptance byphysicians,patients,patient advocacy groups,third-party payors andothers in the medical community necessary for commercial success.(

160、page23)We face substantial competition,rapid technological change and thepossibility that our competitors may discover,develop or commercializedrugs before we do or more successfully than we do,or develop therapiesthat are similar,more advanced or more effective than ours,each of whichmay adversely

161、affect our financial condition and our ability tosuccessfully market or commercialize our drug candidate.(page 24)Even if we are able to commercialize any approved drug candidates,reimbursement may be limited or unavailable in certain market segments forour drug candidates,and we may be subject to u

162、nfavorable pricingregulations,which could harm our business.(page 25)The data and information that we gather in our research and developmentprocess could be inaccurate or incomplete,which may have negativeinfluence on our business,reputation,financial condition and results ofoperations.(page 26)The

163、incidence and prevalence for target patient populations of our drugcandidates are based on estimates and third-party sources.The marketopportunities for our drug candidates,if approved,may be smaller than weanticipate.(page 26)8Table of ContentsWe have been involving in legal proceedings in the ordi

164、nary course of ourbusiness,and are currently involved in active legal proceedings.Anyadverse outcome of these legal proceedings could have a material adverseeffect on our business,results of operations and financial condition.(page 28)We face economic and political risks associated with doing busine

165、ss inTaiwan,particularly due to the geopolitical tension between Taiwan andPRC that could negatively affect our business and hence the value of yourinvestment.(page 30)We are required to comply with extensive regulations and hold a number ofpermits and licenses to carry on our business in Taiwan.Our

166、 ability toobtain and maintain these regulatory approvals is uncertain,and futuregovernment regulation may place additional burdens on our efforts tocommercialize our drug candidates.(page 31)Our future success depends on our ability to attract,retain and motivatesenior management and qualified scie

167、ntific employees.(page 32)If we do not achieve our projected development and commercialization goalsin the timeframes we announced and expected,the commercialization of anyof our drug candidates may be delayed and our business will be negativelyinfluenced.(page 32)Certain of our facilities were mort

168、gaged.If the mortgagees enforce themortgage,our business could be materially and adversely affected.(page33)As we rely on third parties to conduct our clinical trials and provideother important services related to research and development,regulatorysubmissions,and commercialization,if we fail to mai

169、ntain ourrelationships with these third parties or if they do not successfullycarry out their contractual duties,comply with applicable laws,or meetexpected deadlines,we may not be able to obtain regulatory approval foror commercialize our drug candidates and our business could besubstantially harme

170、d.(page 47)If we are unable to obtain and maintain patent and other intellectualproperty protection for our drug candidates,or if the scope of suchintellectual property rights obtained is not sufficiently broad,thirdparties could develop and commercialize products and technologies similaror identica

171、l to ours and compete directly against us,and our ability tosuccessfully commercialize any product or technology may be adverselyaffected.(page 50)Obtaining and maintaining our patent protection depends on compliance withvarious procedural,document submission,fee payment and otherrequirements impose

172、d by government patent agencies,and our patentprotection could be reduced or eliminated for non-compliance with theserequirements.(page 51)If the TFDA,the US FDA or comparable foreign regulatory authoritiesapprove generic versions of any of our products that receive marketingapproval,or such authori

173、ties do not grant our products appropriateperiods of data exclusivity before approving generic versions of ourproducts,the sales of our products could be adversely affected.(page 52)9Table of ContentsTHE OFFERINGOffering Price per Ordinary Share US$per ordinary shareOrdinary Shares Offered by Us ord

174、inary shares(or ordinaryshares if the underwriters exercise in full theiroption to purchase additional ordinary shares).Ordinary Shares OutstandingImmediately Prior to theCompletion of This Offering ordinary shares.Ordinary Shares Issued andOutstanding Immediately AfterThis Offering ordinary shares(

175、or ordinaryshares if the underwriters exercise the option topurchase additional ordinary shares infull).Option to Purchase AdditionalOrdinary Shares We have granted to the underwriters an option,exercisable for 45days from the date of thisprospectus,to purchase up to an aggregate ofadditional ordina

176、ry shares at the initialpublic offering price,less underwritingdiscounts and commissions,solely for the purposeof covering over-allotments.Dividends We do not expect to pay dividends in theforeseeable future.Over-Allotment Option We have granted the underwriters a 45-day optionto purchase up to an a

177、dditional ordinary shares from us atthe initial public offering price less theunderwriting discounts and commissions.Representatives Warrants We have agreed to issue warrants to Joseph StoneCapital,LLC,the representative of theunderwriters(the“Representative”),topurchase such number of ordinary shar

178、es equal to5%of the total number of ordinary share sold inthis offering(including any ordinary shares soldpursuant to the exercise of the over-allotmentoption).Such warrants shall have an exerciseprice equal to 125%of the offering price of theordinary shares sold to investors in thisoffering and may

179、 be exercised on a cashlessbasis.The representatives warrants will beexercisable commencing six months from theclosing of this offering and will terminate onthe fifth anniversary of the commencement ofsales for this offering.Listing We have applied to have our ordinary shareslisted on the Nasdaq Cap

180、ital Market under thesymbol“JYB.”Our ordinary shares will not belisted on any exchange or quoted for trading onany over-the-counter trading system.Transfer Agent Use of Proceeds We estimate that we will receive net proceeds ofapproximately US$million from thisoffering,assuming an initial public offe

181、ringprice of US$per ordinary share,themid-point of the estimated range of the initialpublic offering price,after deducting estimatedunderwriter discounts,commissions and estimatedoffering expenses payable by us.We intend toprimarily use our net proceeds from this offeringfor researching and developi

182、ng new drugs andclinical trials.See“Use of Proceeds”foradditional information.Risk Factors Investing in these securities involves a highdegree of risk.See“Risk Factors”and otherinformation included in this prospectus for adiscussion of the risks you should carefullyconsider before deciding to invest

183、 in ourordinary shares.10Table of ContentsLock-up Our directors and officers and holders of morethan 5%of our outstanding shares as of theeffective date of this registration statementwill enter into customary lock-up agreements infavor of the underwriters for a period of twelve(12)months from the da

184、te of this offering.Ourholders of less than 5%of our outstanding sharesas of the effective date of this registrationstatement will enter into customary lock-upagreements in favor of the underwriters for aperiod of six(6)months from the closing ofthis offering.We have agreed with the underwriters tha

185、t,for aperiod of twelve(12)months from the closing ofthis offering,we and any successors of us willnot(a)offer,pledge,sell,contract to sell,sell any option or contract to purchase,purchaseany option or contract to sell,grant any option,right or warrant to purchase,lend,or otherwisetransfer or dispos

186、e of,directly or indirectly,any shares of capital stock of us or anysecurities convertible into or exercisable orexchangeable for shares of capital stock of us;(b)file or caused to be filed any registrationstatement with the SEC relating to the offeringof any shares of our capital stock or anysecuri

187、ties convertible into or exercisable orexchangeable for shares of our capital stock;or(c)enter into any swap or other arrangementthat transfers to another,in whole or in part,any of the economic consequences of ownership ofour capital stock,whether any such transactiondescribed in clause(a),(b)or(c)

188、above is tobe settled by delivery of shares of our capitalstock or such other securities,in cash orotherwise.See“Underwriting”for moreinformation.11Table of ContentsRISK FACTORSInvesting in the ordinary shares involves a high degree of risk.You shouldcarefully consider the following risks,as well as

189、 other information contained inthis prospectus,before making an investment in our company.The risks discussedbelow could materially and adversely affect our business,prospects,financialcondition,results of operations,cash flows,ability to pay dividends and thetrading price of our ordinary shares.We

190、may face additional risks and uncertaintiesaside from the ones mentioned below.There may be risks and uncertainties that we areunaware of,or that we currently do not consider material,that may become importantfactors that adversely affect our business in the future.Any of the following risksand unce

191、rtainties could have a material adverse effect on our business,financialcondition,results of operations and ability to pay dividends.In such case,themarket prices of the ordinary shares could decline and you may lose part or all ofyour investment.RISKS RELATED TO THE DISCOVERY,DEVELOPMENT AND COMMER

192、CIALIZATION OF OURDRUG CANDIDATESOur business is highly dependent on the success of our core drug candidate,MCS-2.If we are unable to obtain marketing approval for or successfullycommercialize MCS-2,or if we experience significant delays in doing so,our business could be adversely affected.We curren

193、tly have no drug products that are approved for commercial sale.Compared with other companies that have multiple drug candidates in activedevelopment,our business and future success depends in a large part on our abilityto obtain regulatory approval for,and then successfully commercialize our core d

194、rugcandidate,MCS-2.If we cannot obtain approval for MCS-2,which is the initialindication that we are currently exploring,we will have spent substantial time andfinancial resources without receiving a return on investment.The success of MCS-2 will depend on several factors,including the following:tim

195、ely receipt of marketing approvals from applicable regulatoryauthorities;the performance of our future collaborators,if any;the extent of any required post-marketing approval commitments to applicableregulatory authorities;establishment of supply arrangements with third-party raw materialssuppliers;

196、obtaining and maintaining patent,trade secret protection and regulatoryexclusivity,both in Taiwan,the U.S.and internationally;protection of our rights in our intellectual property portfolio;successful launch of commercial sales following any marketing approval;a continued acceptable safety profile f

197、ollowing any marketing approval,andmeeting all applicable post-market commitments,obligations,andrequirements;commercial acceptance of our products,if approved,by patients,the medicalcommunity and third-party payors;andour ability to compete with other therapies.If we do not achieve one or more of t

198、hese factors,many of which are beyond ourcontrol,in a timely manner or at all,we could experience significant delays or aninability to obtain regulatory approvals or commercialize MCS-2.Even if regulatoryapprovals are obtained,we may not be able to successfully commercialize MCS-2 due tovarious fact

199、ors beyond our control.Accordingly,we may not be able to generatesufficient revenue through the sale of MCS-2.12Table of ContentsWe may allocate our limited resources to pursue a particular drugcandidate,indication,or technology and fail to capitalize on existing orfuture drug candidates,indications

200、 or technologies that may later prove tobe more profitable,or for which there is a greater likelihood of success.Because we have limited financial and managerial resources,we intend to focus ondeveloping drug candidates for specific indications that we identify as most likelyto succeed,in terms of b

201、oth their potential for marketing approval andcommercialization.As a result,we may forgo or delay pursuit of opportunities withother drug candidates or for other indications or technologies that later may proveto have greater commercial potential or a greater likelihood of success.Our resourcealloca

202、tion decisions may cause us to fail to capitalize on viable commercial productsor profitable market opportunities.Our spending on current and future research anddevelopment programs and drug candidates for specific indications may not yield anycommercially viable drug candidates.In addition,if we do

203、 not accurately evaluatethe commercial potential or target market for a particular drug candidate ortechnology,we may relinquish valuable rights to that drug candidate or technologythrough collaboration,licensing or other royalty arrangements when it would havebeen more advantageous for us to retain

204、 sole development and commercialization rightsto such drug candidate or technology.For example,we are developing our core drugcandidate,MCS-2,to initially treat BPH/LUTS.We are also considering a number ofadditional indications for MCS-2,including the potential to prevent prostate cancer.We cannot g

205、uarantee that the treatment of BPH/LUTS will be the most profitableindication for MCS-2 as opposed to other contemplated indications.This could resultin us failing to capitalize on the true market potential of our core drug candidatein a timely manner or at all.Although a substantial amount of our e

206、fforts will focus on the continued clinicaltesting,potential approval,manufacturing and commercialization of our existing drugcandidates,the success of our business depends in part upon our ability to identify,license,discover,develop,or commercialize additional drug candidates or newtechnologies.Re

207、search efforts to identify new drug candidates and technologiesrequire substantial technical,financial,and human resources.Although we do notcurrently engage in such activities,we may in the future seek to expand our drugpipeline through in-licensing arrangements.We may end up focusing our efforts a

208、ndresources on potential drug candidates and technologies that ultimately prove to beunsuccessful.Our research and any future licensing efforts may fail to identify,discover or in-license new drug candidates and technologies suitable for clinicaldevelopment and commercialization for a number of reas

209、ons,including,but not limitedto,the following:our research or business development methodology or search criteria andprocess may be unsuccessful in identifying potential drug candidates andtechnologies,or potential drug candidates and technologies that are withinour resources to license or acquire a

210、nd develop;our potential drug candidates and technologies may be shown to have adverseeffects or may have other characteristics that may make the productsunmarketable or unlikely to receive marketing approval;andit may take greater human,financial and/or research resources to identifyadditional ther

211、apeutic opportunities for our drug candidates or to developmore suitable potential drug candidates and technologies than what wepossess,thereby limiting our ability to diversify and expand our drugportfolio.Accordingly,there can be no assurance that we will successfully identify anddevelop new drug

212、candidates or technologies,or additional therapeutic opportunitiesfor our drug candidates,whether through internal research or future licensingefforts,which could materially and adversely affect our future growth and prospects.The COVID-19 pandemic and the monkeypox outbreak could adversely impact o

213、urbusiness including our ongoing and planned clinical trials and preclinicalresearch.Over twoyears after the World Health Organization declared the COVID-19 apandemic,it continues to impact worldwide economic activity and financial markets.Variants of COVID-19 have caused and may continue to cause w

214、aves of increasedinfections.As a result of measures imposed by the governments in affected regions,many commercial activities,businesses and schools have been affected by quarantinesand other measures intended to contain the pandemic and subsequent variants of theCOVID-19 virus.The extent to which t

215、he COVID-19 pandemic ultimately impacts ourbusiness will depend on future developments,which are highly uncertain and cannot bepredicted,such as the duration of the outbreak,including current and subsequentvariants of COVID-19,travel restrictions and social distancing in Taiwan and othercountries,bu

216、siness closures or business disruptions,and the effectiveness ofactions taken in Taiwan and other countries to contain and treat the disease and toaddress its13Table of Contentsimpact,including on financial markets or otherwise.Since early May2022,cases ofmonkeypox have been reported from countries

217、where the disease is not endemic,andcontinue to be reported in several endemic countries.Most confirmed cases withtravel history reported travel to countries in Europe and North America,rather thanWest or Central Africa where the monkeypox virus is endemic.In July 2022,WHOdeclared the monkeypox outb

218、reak a global health emergency.As the COVID-19 pandemicand the monkeypox outbreak continue,we may experience disruptions that couldseverely impact our business,current and planned clinical trials and preclinicalresearch,including:delays or difficulties in enrolling and retaining subjects,includingel

219、derly subjects,who are at a higher risk of severe illness or death fromCOVID-19 and monkeypox,in our ongoing clinical trials and our futureclinical trials;delays or difficulties in clinical site initiation,including due todifficulties in staffing and recruiting at clinical sites;difficulties interpr

220、eting data from our clinical trials due to the possibleeffects of COVID-19 and monkeypox on subjects;diversion of healthcare resources away from the conduct of clinical trials,including the diversion of hospitals serving as our clinical trial sites andhospital staff supporting the conduct of clinica

221、l trials;interruption of key clinical trial activities,such as clinical trial sitemonitoring,due to limitations on travel imposed or recommended by federalor state governments,employers and others;limitations in resources,including our employees,that would otherwise befocused on the conduct of our b

222、usiness or our current or planned clinicaltrials or preclinical research,including because of sickness,the desire toavoid contact with large groups of people,or restrictions on movement oraccess to our facility as a result of government-imposed“shelter inplace”or similar working restrictions;interru

223、ptions,difficulties or delays arising in our existing operations andcompany culture as a result of some or all of our employees workingremotely,including those hired during the COVID-19 pandemic and themonkeypox outbreak;delays in receiving approval from regulatory authorities to initiate ourclinica

224、l trials;interruptions in our preclinical studies due to restricted or limitedoperations;interruptions or delays in the operations of the TFDA,the FDA or otherforeign regulatory authorities,which may impact review and approvaltimelines;delays in receiving the supplies,materials and services needed t

225、o conductclinical trials and preclinical research;changes in regulations as part of a response to the COVID-19 pandemic andthe monkeypox outbreak which may require us to change the ways in which ourclinical trials are conducted,which may result in unexpected costs orrequire us to discontinue the cli

226、nical trial altogether;interruptions or delays to our development pipeline;delays in necessary interactions with regulators,ethics committees andother important agencies and contractors due to limitations in employeeresources or forced furlough of government or contractor personnel;andrefusal of the

227、 TFDA or the FDA to accept data from clinical trials inaffected geographies.The COVID-19 pandemic and the monkeypox outbreak continue to pose a threat on ourability to effectively conduct our business operations as planned.There can be noassurance that we will avoid a material impact on our business

228、 from the spread ofCOVID-19 and monkeypox or its consequences,including disruption to our business anddownturns in business sentiment generally or in our industry or due to shutdowns thatmay be requested or mandated by federal,state and local governmental authorities.14Table of ContentsAdditionally,

229、certain third parties with whom we engage or may engage,includingcollaborators,suppliers,clinical trial sites,regulators and other third partiesare similarly adjusting their operations and assessing their capacity in light of theCOVID-19 pandemic and the monkeypox outbreak.If these third parties exp

230、erienceshutdowns or continued business disruptions,our ability to conduct our business inthe manner and on the timelines presently planned could be materially and negativelyimpacted.For example,as a result of the COVID-19 pandemic,there could be delays inthe procurement of materials or manufacturing

231、 supply chains for one or more of ourdrug candidates,which could delay or otherwise impact our preclinical studies andour planned clinical trials.It is also likely that the disproportionate impact ofthe COVID-19 pandemic or the monkeypox outbreak on hospitals and clinical sites willhave an impact on

232、 recruitment and retention for our planned clinical trials.We mayalso be required to make certain adjustments to the operation of clinical trials inan effort to ensure the monitoring and safety of patients and minimize risks to trialintegrity during the pandemic in accordance with the guidance issue

233、d by the TFDA andthe US FDA.We may need to make further adjustments in the future that could impactthe timing or enrollment of our clinical trials.Many of these adjustments are newand untested,may not be effective,may increase costs and may have unforeseeneffects on the enrollment,progress and compl

234、etion of these trials and the findingsfrom these trials.While we are currently continuing our clinical trials andpreclinical studies,we may experience delays in the completion of our clinicaltrials,preclinical activities and subject enrollment,may need to suspend ourclinical trials and may encounter

235、 other negative impacts to such trials due to theeffects of the COVID-19 pandemic and the monkeypox outbreak.Further,as a result of the COVID-19 pandemic and the monkeypox outbreak,theextent and length of which are uncertain,we may be required to develop and implementadditional clinical trial polici

236、es and procedures designed to help protect subjectsfrom the COVID-19 pandemic and the monkeypox outbreak,which may include usingtelemedicine visits,remote monitoring of subjects and clinical sites and measures toensure that data from clinical trials that may be disrupted as a result of the COVID-19

237、pandemic or the monkeypox outbreak are collected pursuant to the study protocoland consistent with clinical research practices.Subjects who may miss scheduledappointments,any interruption in study drug supply,or other consequences that mayresult in incomplete data being generated during a clinical t

238、rial as a result of thepandemic must be adequately documented and justified.For example,in March2020,the FDA issued a guidance,which the FDA subsequently updated,on conducting clinicaltrials during the pandemic,which describes a number of considerations for sponsorsof clinical trials impacted by the

239、 pandemic,including the requirement to include inthe clinical trial report contingency measures implemented to manage the trial,andany disruption of the trial as a result of the COVID-19 pandemic;a list of allsubjects affected by the COVID-19 pandemic related study disruption by unique subjectidenti

240、fier and by investigational site and a description of how the individualsparticipation was altered;and analyses and corresponding discussions that addressthe impact of implemented contingency measures(e.g.,participant discontinuationfrom investigational product and/or study,alternative procedures us

241、ed to collectcritical safety and/or efficacy data)on the safety and efficacy results reported forthe clinical trial.In June2020,the FDA also issued a guidance on goodmanufacturing practice considerations for responding to COVID-19 infection inemployees in drug product manufacturing,including recomme

242、ndations for manufacturingcontrols to prevent contamination of drugs.Since December 2022,many of the restrictive measures previously adopted by thePRC government at various levels to control the spread of the COVID-19 virus havebeen revoked or replaced with more flexible measures.As a result,there h

243、as recentlybeen and may continue to be an increase in COVID-19 cases in China,which may lead totemporary interruptions to business operations.There remain significantuncertainties surrounding the COVID-19 outbreak,including with respect to theultimate spread of the virus,the severity and duration of

244、 the pandemic and thefurther actions government authorities may take in response.While it is unknown howlong these conditions will last and what the complete financial effect will be on us,we are closely monitoring the impact of COVID-19.Our business,results ofoperations,financial condition and pros

245、pects could be materially adversely affectedto the extent that COVID-19 harms the Chinese and global economy in general.To the extent the COVID-19 pandemic and the monkeypox outbreak adversely affectour business and financial results,it may also have the effect of heightening manyof the other risks

246、described in this section.Clinical development involves a lengthy and expensive process with anuncertain outcome,and results of earlier studies may not be predictive offuture study results.There is a risk of failure for every drug candidate.Clinical testing isexpensive,difficult to design and implem

247、ent and can take manyyears to complete,soits outcome is inherently uncertain.It is difficult to predict when or if any of ourdrug candidates will prove effective and safe in humans or will receive regulatoryapproval,and15Table of Contentsfailure can occur at any time during the preclinical and clini

248、cal developmentprocess.Before obtaining regulatory approval from regulatory authorities for thecommercialization of any drug candidate,our drug candidates must completepreclinical studies and then conduct extensive clinical trials to demonstrate thesafety and efficacy of our drug candidates in human

249、s.The results of preclinical studies and clinical trials of our drug candidates maynot be predictive of the results of later-stage clinical trials.Drug candidatesduring later stages of clinical trials may fail to show the desired results in safetyand efficacy despite having progressed through precli

250、nical studies and initial toadvanced clinical trials and despite the level of scientific rigor in the study,design and adequacy of execution.In some instances,there can be significantvariability in safety and/or efficacy results among different studies of the samedrug candidate due to numerous facto

251、rs,including,but not limited to,differences inindividual patient conditions,including genetic differences,and other compoundingfactors,such as other medications or pre-existing medical conditions.Moreover,preclinical and clinical data are often susceptible to varying interpretations andanalyses,and

252、many companies that have believed their drug candidates performedsatisfactorily in preclinical studies and clinical trials have nonetheless failed toobtain regulatory approval of their drug candidates.In the case of any studies we conduct,results may differ from earlier studiesdue to the larger numb

253、er of clinical trial sites,foreign subjects and differentlanguages involved in such studies.Clinical practices vary globally,and there is alack of harmonization among the guidance provided by various regulatory bodies ofdifferent regions and countries with respect to the data that is required to rec

254、eivemarketing approval,which makes designing global studies increasingly complex.Differing regulatory approval requirements in different countries could make it moredifficult for us to conduct unified global studies,which can lead to increaseddevelopment costs and marketing delays or non-viability o

255、f our clinical trials.Inaddition,regulatory authorities may determine that clinical trial results obtainedin foreign subjects do not adequately represent the results that would be obtained inlocal patients and are thus not supportive of relevant approvals.In particular,if we experience delays in the

256、 start or completion of,ortermination of,any clinical trial of our key drug candidates,PCP and IC,thecommercial prospects of them may be harmed,and our ability to generate productrevenues from our key drug candidates will be delayed.In addition,any delays incompleting our clinical trials will increa

257、se our costs,slow down the development andapproval process for our key drug candidates,and jeopardize our ability to commenceproduct sales and generate revenues.Any of these occurrences may significantly harmour business,financial condition and prospects.In addition,many of the factorsthat cause,or

258、lead to,a delay in the commencement or completion of clinical trialsmay also ultimately lead to the denial of regulatory approval of our key drugcandidates.All of our key drug candidates are in preclinical or clinical development.If we are unable to complete clinical development and obtain regulator

259、yapproval to ultimately commercialize our key drug candidates,or if weexperience significant delays in doing so,our business,financialcondition,results of operations and prospects will be materially harmed.All of our key drug candidates are still in development.Our ability to generaterevenue from ou

260、r key drug candidates is dependent on receipt of regulatory approvaland successful commercialization of such products.We cannot guarantee that we willbe able to obtain regulatory approvals for our existing drug candidates in a timelymanner,or at all,and we may be unable to obtain successful commerci

261、alization of ourkey drug candidates even if we receive regulatory approval.Each of our key drugcandidates will require additional preclinical and/or clinical development,regulatory approvals in multiple jurisdictions,development of commercialmanufacturing supply and capacity,substantial investment a

262、nd significant marketingefforts before we generate any revenue from product sales.The success of our key drug candidates will depend on several factors,including,but not limited to,the following:hiring and maintaining sufficient experts and employees to oversee alldevelopment and regulatory activiti

263、es and meeting of safety requirements;successful completion of preclinical studies and clinical trials,includingthe successful enrollment in such clinical trials;receipt of regulatory approvals from applicable regulatory authorities forplanned and future clinical trials,drug registration,manufacturi

264、ng andcommercialization;16Table of Contentssuccessful completion of all studies required to obtain regulatory approvalin the UnitedStates,Taiwan,China,Europe and other jurisdictions wherewe intend to market our key drug candidates;our ability to establish manufacturing capabilities and capacities,wh

265、etherinternally or through third-party cooperators,to the specifications of ourkey drug candidates for clinical supply;obtaining and maintaining patent,trade secret and other intellectualproperty protection and/or regulatory exclusivity for our key drugcandidates;launching commercial sales of our ke

266、y drug candidates,if and when approved,whether alone or in collaboration with others;acceptance of the drug candidates,if and when approved,by patients,themedical community and third-party payors;obtaining and maintaining healthcare coverage and adequate reimbursement;effectively competing with othe

267、r therapies and alternative drugs;successfully enforcing and defending intellectual property rights andclaims;andmaintaining a continued acceptable safety profile of the drug candidatesfollowing regulatory approval,and meeting all applicable post-marketcommitments,obligations,and requirements.Any si

268、gnificant delays in,or an inability to,obtain regulatory approval andultimately achieve commercial success for our existing and future drug candidates inone or more jurisdictions would materially harm our business and we may not be ableto generate enough revenues and cash flows to continue our opera

269、tions,includingdelays due to the COVID-19 pandemic and the monkeypox outbreak could furthermaterially harm our business.As a result,our financial condition,results ofoperations and prospects will be materially and adversely harmed.If we encounter delays or difficulties enrolling and retaining patien

270、ts inour clinical trials,our clinical development progress and our receipt ofnecessary regulatory approvals could be delayed or otherwise adverselyaffected.The timely completion of clinical trials in accordance with their protocolsdepends,among other things,on our ability to enroll a sufficient numb

271、er of patientsthat will remain in the study until its conclusion.We may not be able to initiate orcontinue clinical trials for our drug candidates if we are unable to locate andenroll a sufficient number of eligible patients to participate in these studies asrequired by the TFDA,the US FDA,and any o

272、ther applicable similar regulatoryauthorities,or if there are delays in the enrollment of eligible patients as aresult of the competitive clinical enrollment environment.Even once enrolled,we maybe unable to retain a sufficient number of patients to complete any of our trials.The inability to enroll

273、 a sufficient number of patients who meet the applicablecriteria for our clinical trials would result in significant delays and could requireus to abandon one or more clinical trials altogether.If patients are unwilling toenroll in our clinical trials because of the COVID-19 pandemic,the monkeypoxou

274、tbreak and restrictions on travel or healthcare institution policies,negativepublicity from adverse events related to the pharmaceutical industry or for otherreasons,the timeline for recruiting patients,conducting studies and obtainingregulatory approval of our drug candidates may be delayed.As of t

275、he date of thisprospectus,we have not encountered any delays or difficulties enrolling andretaining patients in our clinical trials,however,we cannot predict or guaranteethat we will be successful at enrolling subjects in future clinical trials.Even ifwe are able to enroll a sufficient number of pat

276、ients in our clinical trials,delaysin patient enrollment could result in increased development costs,delays inadvancing our drug candidates,delays in testing the effectiveness of our drugcandidates or termination of clinical trials altogether.Patient enrollment for our clinical trials may be affecte

277、d by other factors,including,but not limited to,the following:severity of the disease under investigation;total size and nature of the relevant patient population;design and eligibility criteria for the clinical trial in question;perceived risks and benefits of the drug candidate under study;17Table

278、 of Contentsour resources to facilitate timely enrollment in clinical trials;patient referral practices of physicians;availability of competing therapies also undergoing clinical trials;our investigators or clinical trial sites efforts to screen and recruiteligible patients;our ability to maintain p

279、atient consents;ability to monitor patients adequately during and after treatment;proximity and availability of clinical trial sites for prospective patients;andthe occurrence of any pandemic,epidemic or any other public health crises,including from the COVID-19 pandemic,the monkeypox outbreak,natur

280、alcatastrophe or other disasters that may cause a delay in enrollment ofpatients in clinical trials.Additionally,our ability to successfully initiate,enroll and complete clinicaltrials in any foreign country is subject to numerous risks unique to conductingbusiness in foreign countries,including:dif

281、ficulty in establishing or managing relationships with our cooperators,including but not limited to research institutions,hospitals andphysicians;different standards for the conduct of clinical trials;absence in some countries of established groups with sufficient regulatoryexpertise for review of c

282、linical trial protocols;inability to locate qualified local consultants,physicians and cooperators;andthe potential burden of complying with a variety of foreign laws,medicalstandards and regulatory requirements.In addition,our clinical trials may compete with other clinical trials for drugcandidate

283、s that are in the same therapeutic areas as our drug candidates,and thiscompetition will reduce the number and types of patients available to us,becausesome patients who might have opted to enroll in our trials may instead opt to enrollin a trial being conducted by one of our competitors.Because the

284、 number of qualifiedclinical investigators and clinical trial sites is limited,we expect to conduct someof our clinical trials at the same clinical trial sites that some of our competitorsuse,which will reduce the number of patients who are available for our clinicaltrials at such clinical trial sit

285、es.For example,although we have not encounteredany delays or difficulties in enrolling or retaining patients for our clinical trialsin the past,we may in the future experience such delays or difficulties due togovernment orders and site policies on account of health epidemics such as thecontinuation

286、 of the COVID-19 pandemic and the monkeypox outbreak,and some patientsmay be unwilling or unable to travel to study sites,enroll in our studies or complywith clinical trial protocols if quarantines impede patient movement or interrupthealthcare services.If we have difficulty enrolling a sufficient n

287、umber of patientsor finding additional clinical trial sites to conduct our clinical trials as planned,we may need to delay,limit or terminate ongoing or planned clinical trials,any ofwhich could have an adverse effect on our business,financial condition,results ofoperations and prospects.In addition

288、,it is possible that the COVID-19 pandemic andthe monkeypox outbreak may have an impact on the workforce of the third parties onwhich we rely,which could adversely impact our ability to conduct preclinicalstudies,enroll and retain patients in our clinical trials and conduct the clinicaltrials of our

289、 drug candidates on expected timeframes or to complete such studies,andour ability to ultimately obtain regulatory approval.As a result,the value of ourCompany could decline and our ability to obtain additional financing may be impaired.18Table of ContentsIf clinical trials of our key drug candidate

290、s fail to demonstrate safetyand efficacy to the satisfaction of regulatory authorities or do nototherwise produce positive results,we may incur additional costs orexperience delays in completing,or ultimately be unable to complete,thedevelopment and commercialization of our drug candidates.Before ob

291、taining regulatory approval for the sale of our drug candidates,we mustconduct extensive clinical trials to demonstrate the safety and efficacy of our drugcandidates in humans.We may experience numerous unexpected events during,or as aresult of,clinical trials that could delay or prevent our ability

292、 to receiveregulatory approval or commercialize our drug candidates,including,but not limitedto,the following:regulators,institutional review boards,or IRBs,or ethics committees maynot authorize us or our investigators to commence a clinical trial orconduct a clinical trial at a prospective study si

293、te;delay in reaching,or failure to reach,agreements on acceptable terms withprospective CROs and study sites,the terms of which can be subject toextensive negotiation and may vary significantly among different CROs andstudy sites;manufacturing issues,including problems with manufacturing,supply qual

294、ity,compliance with current good manufacturing practices,or obtainingsufficient quantities of a drug candidate from third parties for use in aclinical trial;clinical trials of our drug candidates may produce negative or inconclusiveresults,and we may decide to conduct additional clinical trials or a

295、bandonthe development of such drug candidates,or regulators may require us to doso;the number of patients required for clinical trials of our drug candidatesmay be larger than we anticipate,enrollment may be insufficient or slowerthan we anticipate,or patients may drop out or fail to return for post

296、-treatment follow-up at a higher rate than we anticipate;our third-party contractors used in our clinical trials,including anyclinical investigators,may fail to comply with regulatory requirements ormeet their contractual obligations to us in a timely manner,or at all,ormay deviate from clinical tri

297、al protocol or dropout of clinical trials,which may require that we add new clinical trial sites or clinicalinvestigators;we might have to suspend or terminate clinical trials of our drug candidatesfor various reasons,including a finding of a lack of clinical response,serious adverse,undesirable or

298、unacceptable side effects or otherunexpected characteristics or a finding that participants are being exposedto unacceptable health risks;we may elect to,or regulators,IRBs or ethics committees may require thatwe or our investigators,suspend or terminate clinical research or not relyon the results o

299、f clinical research for various reasons,including non-compliance with regulatory requirements;the cost of clinical trials of our drug candidates may be greater than weanticipate;andthe supply or quality of our drug candidates or other materials necessary toconduct clinical trials of our drug candida

300、tes may be insufficient orinadequate.If we are required to conduct additional clinical trials or other testing of ourdrug candidates beyond those that we currently plan,if we are unable to successfullycomplete clinical trials of our drug candidates or other testing,if the results ofthese studies or

301、tests are not positive or are only modestly positive,or if theyraise safety concerns,we may(i)be delayed in obtaining regulatory approval forour drug candidates;(ii)obtain approval for indications or patient populationsthat are not as broad as intended or desired;(iii)not obtain regulatory approvala

302、t all;(iv)have the drug removed from the market after obtaining regulatoryapproval;(v)be subject to additional post-marketing testing requirements;(vi)besubject to restrictions on how the drug is distributed or used;or(vii)be unableto obtain reimbursement for use of the drug.Many of the factors that

303、 cause a delayin the commencement or completion of clinical trials may also ultimately lead to thedenial of regulatory approval of our drug candidates.Further,the TFDA,the US FDAor other regulatory authorities may disagree with our clinical trial design or ourinterpretation of data from clinical tri

304、als,or may change the requirements forapproval even after it has reviewed and commented on the design for our clinicaltrials.19Table of ContentsOur clinical trials are conducted in multiple jurisdictions,which maysubject us to delays and expenses.We are currently conducting clinical trials,through t

305、hird-party CROs,in Taiwanand the U.S.There are risks inherent in conducting clinical trials in multiplejurisdictions,which may subject us to delays and expenses,such as:regulatory and administrative requirements of the jurisdiction where thestudy is conducted that could burden or limit our ability t

306、o conductclinical trials;differing and conflicting regulatory requirements;foreign exchange fluctuations;manufacturing,customs,shipment and storage requirements;cultural differences in medical practice and clinical research;andthe risk that the patient populations in such trials are not consideredre

307、presentative as compared to the patient population in the target marketswhere approval is being sought.Our drug candidates may cause serious adverse,undesirable or unacceptableside effects or have other properties that could delay or prevent theirregulatory approval,limit the commercial profile of a

308、n approved label,and/or result in significant negative consequences following regulatoryapproval,if any.As is the case with pharmaceuticals generally,it is likely that there may beserious adverse,undesirable or unacceptable side effects caused by our drugcandidates that could cause us or regulatory

309、authorities to interrupt,delay or haltclinical trials and may result in a more restrictive label,a delay or denial ofregulatory approval by the TFDA,the US FDA or other comparable regulatoryauthorities,or a significant change in our clinical trial protocols or even ourdevelopment plan.Results of our

310、 future preclinical studies and clinical trials couldreveal a high and unacceptable severity or prevalence of adverse events.In such anevent,our studies could be suspended or terminated and the TFDA,the US FDA or othercomparable regulatory authorities could order us to cease further development of,o

311、rdeny approval of,our drug candidates for any or all targeted indications.Adverseevents related to our drug candidates may affect patient recruitment or the abilityof enrolled subjects to complete the study and could result in potential liabilityclaims.Any of these occurrences may significantly infl

312、uence our reputation,business,financial condition and prospects.Additionally,the identification of serious adverse,undesirable or unacceptableside effects caused by any of our future approved drug candidates may lead topotentially significant negative consequences,which include,but are not limited t

313、o,the following:suspension of our marketing of the drug candidate;withdrawal or revocation by regulatory authorities of their approvals of orthe licenses for the drug candidate;the requirement by regulatory authorities to conduct additional clinicaltrials,add additional warnings to,or otherwise chan

314、ge,the label of thedrug candidate,such as a“black box”warning or contraindication,orcreate a medication guide outlining the risks of such side effects fordistribution to patients;restriction on the distribution of the drug candidate or imposition ofburdensome implementation requirements on us throug

315、h the establishment of aRisk Evaluation and Mitigation Strategy,or REMS,or similar strategy as maybe required by the US FDA or a comparable regulatory authority;the requirement by regulatory authorities to conduct specific post-marketingstudies of the drug candidate;the requirement to change the way

316、 the drug candidate is distributed oradministered;becoming subjected to regulatory investigations,government enforcementactions or litigation proceedings,and being held liable for harm caused tosubjects or patients;the product becoming less competitive;20Table of Contentsremoval of drug candidates f

317、rom the marketplace;andharm to our reputation.Any of these events could prevent us from achieving or maintaining marketacceptance of any particular drug candidate that is approved and could significantlyharm our business,results of operations and prospects.Further,the use of our drug candidates in c

318、onjunction with other therapies,mayresult in unique adverse events that could be exacerbated compared with adverseevents from the use of our drug candidates alone.Results of our studies could reveala high and unacceptable severity or prevalence of adverse events.These types ofadverse events could be

319、 caused by our drug candidates and could cause us orregulatory authorities to interrupt,delay or halt clinical trials and may result ina more restrictive indication or the delay or denial of regulatory approval by theTFDA,the US FDA or other comparable regulatory authority.The manufacture of our dru

320、g products is a complex process which requiressignificant expertise and capital investment,and if we encounter problemsin establishing our manufacturing capabilities for clinical or commercialscale or in the manufacture of our future products,our business couldsuffer.The manufacture of our drug prod

321、ucts is a complex process,in part due to strictregulatory requirements.If we are unable to identify an appropriate production siteor suitable collaborators to develop our manufacturing infrastructure,or fail to doso in a timely manner,this may lead to significant delays in the clinical supply ofour

322、drug candidates as well as the commercial manufacturing of our drug candidatesonce regulatory and marketing approvals have been obtained.In turn,this could delayour clinical trials,negatively impact our ability to ultimately obtain regulatoryapproval and materially harm any future commercialization

323、plans.In addition,problems may arise during the manufacturing process for a variety ofreasons,including,but not limited to,equipment malfunction,failure to followspecific protocols and procedures,problems with(including shortage of)rawmaterials,global supply chain issues,delays related to the constr

324、uction of newfacilities or expansion of any future manufacturing facilities,including changes inmanufacturing production sites and limits to manufacturing capacity due to regulatoryrequirements,changes in the types of products produced,increases in the prices ofraw materials,physical limitations tha

325、t could inhibit continuous supply,man-made ornatural disasters and environmental factors.For example,although we have notexperienced material supply disruptions due to the COVID-19 pandemic,we cannotguarantee that we will not experience supply disruptions in the future due to theCOVID-19 pandemic or

326、 any other pandemics,epidemics or other public health crises,natural catastrophes or other disasters.If problems arise during the production of abatch of future products,that batch of future products may have to be discarded andwe may experience product shortages or incur added expenses.This,as well

327、 asproblems that may arise during the manufacturing process,could,among other things,lead to significant additional costs and/or delays,lost revenue,damage to customerrelationships,time and expense spent investigating the cause and,depending on thecause,similar losses with respect to other batches o

328、r products.If problems are notdiscovered before such product is released to the market,recall and productliability costs may also be incurred.Changes in our drug candidates manufacturing or formulation may result inadditional costs or delay.As our drug candidates are developed through preclinical st

329、udies to late-stageclinical trials towards approval and commercialization,it is common that variousaspects of the development program,such as manufacturing methods and formulation,are altered in an effort to optimize processes,which may not pass regulatoryinspections.If we engage in the scale-up of

330、manufacturing,we may encounterunexpected issues relating to the manufacturing process or the quality,purity andstability of the product,and we may be required to refine or alter our manufacturingprocesses to address these issues.Such changes may not achieve these intendedobjectives.Any of these chan

331、ges could cause our product candidates to performdifferently and affect the results of preclinical studies and clinical trials.Suchchanges may also require additional testing,notification or approval by relevantregulatory authorities,including additional pharmacokinetics or pharmacodynamicstrials.Th

332、is could delay completion of preclinical studies and clinical trials;require us to conduct bridging clinical trials or studies,or to repeat one or moreclinical trials;increase study or clinical trial costs;or delay approval of ourproduct candidates and jeopardize our ability to commence product sale

333、s and generaterevenue.21Table of ContentsWe have not yet obtained marketing approval for a drug candidate and we maybe unable to obtain,or may be delayed in obtaining,marketing approval forour drug candidates.We have not yet obtained marketing approval for a drug candidate.It is possiblethat the TFDA,the US FDA or other comparable regulatory authority may refuse toaccept for review any NDAs that w