瑞科生物-B2023年报

江蘇瑞科生物技術股份有限公司Jiangsu Recbio Technology Co., Ltd. ( a joint stock company incorporated in the People’s Republic of China with limited liability)（於中華人民共和國註冊成立的股份有限公司） Stock Code股份代號: 2179 ANNUAL REPORT2023年 報 Contents 2Corporate Information公司資料5Chairman’s Statement主席致辭7Financial Highlights財務摘要8Management Discussion and Analysis管理層討論與分析35Biographies of our Directors, Supervisors andSenior Management董事、監事及高級管理層履歷52Directors’ Report董事會報告96Corporate Governance Report企業管治報告125Independent Auditor’s Report獨立核數師報告134Consolidated Statement of Profit or Loss andOther Comprehensive Income綜合損益及其他全面收益表135Consolidated Statement of Financial Position綜合財務狀況表137Consolidated Statement of Changes in Equity綜合權益變動表139Consolidated Statement of Cash Flows綜合現金流量表141Notes to Financial Statements財務報表附註239Definitions and Glossary of Technical Terms釋義及技術詞彙 Corporate Information DIRECTORS 1 Executive Directors1 劉勇博士（董事會主席兼總經理）陳健平博士李布先生陳青青女士 Dr. LIU Yong(Chairman of the Board and General Manager)Dr. CHEN JianpingMr. LI BuMs. CHEN Qingqing 2 Non-Executive Directors2 Dr. HONG KunxueDr. ZHOU HongbinDr. ZHANG JiaxinMr. HU Houwei 洪坤學博士周宏斌博士張佳鑫博士胡厚偉先生 Independent Non-Executive Directors 梁國棟先生夏立軍博士GAO Feng教授袁銘輝教授 Mr. LIANG GuodongDr. XIA LijunProfessor GAO FengProfessor YUEN Ming Fai SUPERVISORS 喬偉偉女士（主席）王飛舟先生錢然婷女士劉平女士 Ms. QIAO Weiwei(Chairwoman)Mr. WANG FeizhouMs. QIAN RantingMs. LIU Ping JOINT COMPANY SECRETARIES 陳青青女士何燕群女士 Ms. CHEN QingqingMs. HO Yin Kwan AUTHORISED REPRESENTATIVES 劉勇博士李布先生 Dr. LIU YongMr. LI Bu 1Ms. CHEN Qingqing was appointed as an executive Directoron May 11, 2023.2Mr.ZHAO Hui and Dr.DU Wei resigned as non-executiveDirectorsand members of the Remuneration and AppraisalCommitteeon March 20,2023;Dr.FENG Tao resigned asanon-executive Director and a member of the NominationCommittee on April 3, 2023; Dr. ZHANG Jiaxin and Mr. HUHouwei were appointed as non-executive Directors on May 11,2023. 1陳青青女士於2023年5月11日獲委任為執行董事。2趙輝先生及杜威博士於2023年3月20日辭任非執行董事及薪酬與考核委員會委員職務；逢濤博士於2023年4月3日辭任非執行董事及提名委員會委員職務；張佳鑫博士及胡厚偉先生於2023年5月11日獲委任為非執行董事。 Corporate Information AUDIT COMMITTEE 夏立軍博士（主席）袁銘輝教授周宏斌博士 Dr. XIA Lijun(Chairman)Professor YUEN Ming FaiDr. ZHOU Hongbin REMUNERATION AND APPRAISAL COMMITTEE 袁銘輝教授（主席）夏立軍博士梁國棟先生GAO Feng教授李布先生 Professor YUEN Ming Fai(Chairman)Dr. XIA LijunMr. LIANG GuodongProfessor GAO FengMr. LI Bu NOMINATION COMMITTEE 劉勇博士（主席）GAO Feng教授梁國棟先生夏立軍博士 Dr. LIU Yong(Chairman)Professor GAO FengMr. LIANG GuodongDr. XIA Lijun H H SHARE REGISTRAR 香港中央證券登記有限公司香港灣仔皇后大道東183號合和中心17樓1712至1716號舖 Computershare Hong Kong Investor Services LimitedShops 1712-1716, 17th FloorHopewell Centre183 Queen’s Road EastWan ChaiHong Kong HEAD OFFICE AND REGISTERED OFFICE IN THE PRC 中國江蘇省泰州市醫藥高新區藥城大道888號 No. 888 Yaocheng AvenueMedical High-tech DistrictTaizhou CityJiangsu Provincethe PRC PRINCIPAL PLACE OF BUSINESS IN HONG KONG 香港灣仔皇后大道東248號大新金融中心40樓 40th Floor, Dah Sing Financial CentreNo. 248 Queen’s Road EastWanchaiHong Kong Corporate Information COMPLIANCE ADVISER 東吳證券國際融資有限公司香港皇后大道東1號太古廣場三座17樓 Soochow Securities International Capital LimitedLevel 17, Three Pacific Place1 Queen’s Road EastHong Kong PRINCIPAL BANK 招商銀行股份有限公司泰州分行中國江蘇省泰州市海陵區鼓樓南路293號10號樓 China Merchants Bank Co., Ltd.Taizhou BranchBuilding 10, No. 293, Gulou South RoadHailing DistrictTaizhou CityJiangsu Province, the PRC HONG KONG LEGAL ADVISOR 高偉紳律師行香港康樂廣場一號怡和大廈27樓 Clifford Chance27/F, Jardine HouseOne Connaught PlaceHong Kong PRC LEGAL ADVISOR 中倫律師事務所中國北京市朝陽區金和東路20號院正大中心南塔22-31層 Zhong Lun Law Firm22-31/F, South Tower of CP Center20 Jin He East AvenueChaoyang DistrictBeijing, the PRC AUDITOR 安永會計師事務所執業會計師註冊公眾利益實體核數師香港鰂魚涌英皇道979號太古坊一座27樓 Ernst & YoungCertified Public AccountantsRegistered Public Interest Entity Auditor27/F, One Taikoo Place979 King’s RoadQuarry Bay, Hong Kong COMPANY’S WEBSITE www.recbio.cn www.recbio.cn STOCK CODE 21792179 Chairman’s Statement 致各位股東： Dear Shareholders, 2023年全體瑞科人銘記「創制一流疫苗，守護人類健康」的使命，以公司戰略為導向，披荊斬棘，砥礪前行，在充滿挑戰的大環境下交出了一份令人滿意的答卷。公司前期對各產品管線的研發和商業化投入在2023年收獲了多個里程碑性成果。 In 2023, bearing in mind the mission of “developing the first-classvaccines to protect human health” and guided by the Company’sstrategy, all Recbio people braved the obstacles, strived forward,and ultimately delivered satisfactory outcomes in a challengingenvironment.The Company’s early investment in research anddevelopment and commercialization of various pipelines reapedmultiple milestone achievements in 2023. 重組九價HPV疫苗REC603的中國III期臨床試驗已進入第30個月的訪視觀察階段，朝申報上市又前進了一大步；另一個戰略級產品新佐劑重組帶狀疱疹病毒疫苗REC610已獲准在中國開展I期和III期臨床試驗，目前已完成中國I期臨床試驗全部受試者入組，並在菲律賓首次人體(FIH)臨床試驗期中取得了出色結果；搭載了我司自主研發的新型佐劑BFA01的重組呼吸道合胞病毒疫苗REC625，臨床前研究進展順利。公司新型佐劑的研發和商業化實力得到了國際組織的認可，被納入由CEPI管理的疫苗新佐劑庫。公司已相繼同兩家產業鏈合作夥伴簽署聯合開發協議，向其提供創新佐劑解決方案，聯合開發新佐劑呼吸道合胞病毒疫苗和新佐劑狂犬疫苗。 Thephase III clinical trial of recombinant HPV 9-valentvaccineREC603 in China has entered its 30th month of visitandobservation,marking another big step toward the newdrugapplication.Another strategic product,REC610