寿康集团2022年年报

CONTENTS 目录 2PerformanceOverview业绩概览 5Chairman’sStatement主席报告 9CEO’sReport行政总裁报告 20Directors’Report董事会报告 63BiographicalDetailsofDirectorsandSeniorManagement 69Management’sDiscussionandAnalysisoftheGroup’sPerformance 董事及高级管理层之履历详情 管理层对本集团业绩之讨论及分析 76 106 132 139 141 143 145 147 266 272 CorporateGovernanceReport企业管治报告Environmental,SocialandGovernanceReport环境、社会及管治报告IndependentAuditor’sReport独立核数师报告ConsolidatedStatementofComprehensiveIncome综合全面收益表ConsolidatedStatementofFinancialPosition综合财务状况表ConsolidatedStatementofChangesInEquity综合权益变动表ConsolidatedStatementofCashFlows综合现金流量表 NotestotheFinancialStatements财务报表附注 Definitions释义 CorporateInformation公司资料 P业E绩RF概OR览MANCEOVERVIEW Asummaryofthefinancialperformanceandothernotableeventsfortheyearended31December2022include: •AlossattributabletoshareholdersoftheCompanyofapproximatelyUS$36.43million,whichwasmainlyattributableto:(i)atotalamortisationchargeofapproximatelyUS$24.95millionontheintangibleassets,beinganon-cashitem;(ii)theGroup’soperatingandR&DexpensesofapproximatelyUS$6.02million;and (iii)arealisedandanunrealisedmarked-to-marketlossinrespectoftheCompany’sequityportfolioofFAFVPLofapproximatelyUS$3.78millionandUS$0.35million,respectively. •Shareholders’equitywasapproximatelyUS$2.60millionasat31December2022,adecreaseofapproximately93.30%ascomparedwiththatasat31December2021,withthedecreasebeingmainlyattributabletothelossattributabletoshareholdersoftheCompany.Postyear-endandthecompletionoftheSetOffandRightsIssue,theCompany’sshareholders’equityincreasedbyapproximatelyUS$21.67million. ， •InrespectoftheprogressbeingmadewithSenstend™inthePRC,ofthethreedrugtrialsthatWanbangBiopharmaceuticalregisteredinDecember2021withtheCentreofDrugEvaluation(http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml),thetwoPhase1studiesandthePhase3RCTwerecompleted.TheCompany,itsregulatoryconsultantandWanbangBiopharmaceuticalhavecommencedthepreparatoryphaseforpreparingtheNDAtoNMPAwiththeaimofsubmittingtheNDAduringQ32023(providedthattheRCTmeetsitsendpoints).IftheNDAissubmittedandtheNMPAgrantsanimportlicenceforSenstend™US$5million(beforedeductionofPRCwithholdingtax)willbepayabletotheGroupfromWanbangBiopharmaceutical.Inaddition,uponfirstcommercialsaleofSenstend™inChina,US$2million(beforedeductionofPRCwithholdingtax)shallbepayabletotheGroupfromWanbangBiopharmaceutical. 截至二零二二年十二月三十一日止年度之财务业绩概要及其他重要事件包括： •本公司股东应占亏损约36,430,000美元，主要是由于：（i）无形资产之摊销费用总额约24,950,000美元（属非现金项目）；（ii）本集团的营运及研发开支约6,020,000美元；及（iii）本公司股本投资组合内之透过损益账按公允价值处理之金融资产之已变现及未变现按市值计价亏损分别约3,780,000美元及350,000美元。 •于二零二二年十二月三十一日的股东权益约2,600,000美元，较二零二一年十二月三十一日减少约93.30%，减少主要源自本公司股东应占亏损。年终以及抵销及供股完成后，本公司股东权益增加约21,670,000美元。 •SenstendTM于中国的进展方面，江苏万邦医药于二零二一年十二月于药物评价中心（http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml）注册的三项药物试验中，两项第一期研究及第三期随机化临床试验已完成。本公司、其监管顾问及江苏万邦医药已开展新药申请筹备阶段，旨在于二零二三年第三季度向国家药品监督管理局提交新药申请（须待随机化临床试验达致其终点）。倘新药申请已提交及国家药品监督管理局授予SenstendTM进口许可证，则江苏万邦医药将须向本集团支付5,000,000美元（扣除中国预扣税前）。此外，SenstendTM于中国进行首次商业销售后，江苏万邦医药将须向本集团支付2,000,000美元（扣除中国预扣税前）。 2ENDURANCERPLIMITED寿康集团有限公司 业绩概览 PERFORMANCEOVERVIEW FortacinTM产品开发举行“C型”会议。在该 的临床研究组织已完成第三期研究方 •InrespectoftheprogressbeingmadewithFortacin™intheUS,theCompany’sclinicalresearchorganisationcompletedthePhase3studyprotocolandhelda“TypeC”meetingwiththeFDAfortheproductdevelopmentofFortacin™Followingpositivefeedbackfromthatmeeting,aroadmapwassetoutwiththerequirementsforsubmittingtheNDAwiththeteamworkingtowardsinfirsttheinstancethesigningofaspecialprotocolassessmentwiththeFDAinQ22023followedbythecommencementofthePhase3studies. •FortacinTM于美国的进展方面，本公司案及与美国食品及药品监督管理局就会定了议包获括得提正交面新反药馈申的请情要况求下，的本路公线司图制，团美队国首食先品致及力药于品二监零督二管三理年局第签二署季特度殊与方 案评估，随后开始第三阶段的研究。 。 •InrespectofEurope,ourEuropeancommercialpartner•engagedwithanalternativeEuropeanthird-partymanufacturerformanufacturingFortacin™overthelast 18monthstosourcealternativecommercialsupplyforFortacin™.Inthisrespect,ourEuropeancommercialpartnersubmittedatypeIIvariationtotheEMAforaddingtheEuropeanmanufacturertothemarketingdossierasanalternativemanufacturer,whichwasapprovedbytheEMAinQ32022.ThealternativemanufacturerstartedproductioninDecember2022,withthefirsttwobatchesbeingreleasedtoourEuropeancommercialpartnerinFebruary2023forGermanyandItaly.WeremainhopefulthatthisnewmanufacturerwillbeabletooffercontinuoussupplyofFortacin™toourEuropeancommercialpartnerandourothercommercialstrategicpartnersbringinginroyaltyrevenuefortheGroup. •Fromabusinessdevelopmentstandpoint,theGrouphas•continuedtoimplementandintegrateDeepLongevity,acquiredinDecember2020,withourexistingbusiness.DeepLongevityiscontinuingitsgrowthjourneywithmultipleinitiativesaroundbuildingouttheteam,product,technologyandcommercialmodels.Duringtheyear,DeepLongevityLimited(“DLL”),awholly-ownedsubsidiaryofDeepLongevity,hastakenthesignificantstepofhiring anewandexperiencedCEO,Deepankar(Deep)Nayak,toredefinethestrategyofthecompany,andtaketheorganisationforward.DeepLongevityiscommittedtobuildingandcommercialisingvariousagingclocksusingitsAIleddeeplearningmodels. •PursuanttotheGr