健世科技-B2025 中期报告

寧波健世科技股份有限公司Jenscare Scientific Co., Ltd. （於中華人民共和國註冊成立的股份有限公司）股份代號: 9877 2025中 期 報 告 目錄 2 5 7 8 11 25 36 37 38 41 授權代表 董事會 3.05 TAN Ching 核數師 安永會計師事務所97927 法律顧問 美邁斯律師事務所131 監事 通商律師事務所1000041212-14 審核委員會 薪酬與考核委員會 註冊辦事處、總部及中國主要營業地點 777B5 提名委員會 於香港的主要營業地點 24840 戰略委員會 聯席公司秘書 2025 公司網站www.jenscare.com 股份代號9877 上市日期 H股股份過戶登記處 香港中央證券登記有限公司183171712-1716 主要往來銀行 中國農業銀行寧波市杭州灣新區支行895 13.412.125.5 91.894.22.4 LuX-Valve Plus(randomized controlled trial, RCT)(NMPA)LuX-Valve PlusTRINITY研究EuroPCR 202530FDA IDEKen-ValveNMPAJensClipNMPA 1LuX-Valve Plus •LuX-Valve PlusLuX-Valve Plus(RCT)NMPANMPANMPANMPA •LuX-Valve PlusCETRINITY6TRINITY302025EuroPCRLuX-Valve Plus11LuX-Valve PlusTRINITY302025New York ValvesLuX-Valve PlusTRINITY30TRINITY6TCT •LuX-Valve PlusFDATAPFDA IDEEFS(CMS)(Pivotal Study) •LuX-Valve Plus 2Ken-Valve •Ken-Valve •Ken-Valve29mm31mm 33mm104 •Ken-Valve8.708.8597.18%1100% •Ken-ValveTAVRKen-ValveKen-Valve 3JensClipNMPA •JensClipNMPA •JensClip TMVrEuroPCR 20251.8%96.3% •JensClipJensClipJensClipCE •JensClip 4 • •LuX-Valve Plus •Ken-Valve100KOL •JensClip • • I.業務回顧 LuX-ValveKen-Valve LuX-Valve PlusLuX-Valve PlusLuX-Valve PlusLuX-Valve Plus LuX-Valve NMPA臨床及註冊 LuX-Valve PlusNMPALuX-ValvePlus(RCT)NMPANMPANMPA LuX-Valve Plus TRAVEL II(TCT2024)12.50%4.17%98.8%NYHA85%III/IVI/IIKCCQ21 CE臨床及註冊 TRINITYLuX-Valve Plus2016118LuX-Valve PlusLuX-Valve PlusTRINITYCETRINITY6TCT LuX-Valve PlusLuX-Valve PlusCE TRINITY30EuroPCR 202597%41.6019.62113014.8%MVARC4.0%8.7%3095.7%84.1%I/IIKCCQ146(6MWD)20TRINITY30LuX-Valve Plus TRINITY30TRINITY75%55mm60mm65mm70mmLAP77.4Tri-Score13.6%9.73%3+Severe47.79%4+Massive42.48%5+Torrential30N=11315.9%0.9%4.4%9.7%N=3611.1%2.8%2.8%5.6%3095.4%83.7%I/IIKCCQ15630TRINITY FDA臨床及註冊 LuX-Valve PlusEFSFDA(Pivotal Study) EFS pre-submission(FDA)LuX-ValvePlusFDA TAPFDALuX-Valve Plus(Investigational DeviceExemption, IDE)(Full Approval)LuX-Valve Plus(Centers for Medicare & Medicaid ServicesCMS)CMSLuX-Valve Plus LuX-Valve PlusLuX-Valve8006 LuX-ValveLuX-ValveLuX-Valve綠色通道LuX-Valve(PCR London Valves 2023)LuX-ValveJACCCARDIOVASCULAR INTERVENTIONS Ken-ValveKen-Valve TAVRKen-Valve Ken-ValveKen-Valve Ken-Valve(CSHC 2025)70.315.5099.3%NYHA/61.97%80.85%5≥632mm8.708.8597.18%5.63%Ken-Valve1100%(EOA)≥1.90cm2 Ken-ValveKen-Valve KenFlexKenFlexKenFlex JensClipJensClipJensClipJensClip JensClip2025EuroPCRJensClip(DMR)1811495%67.5343.89711.8%5.3%0.9%96.3% JensClipJensClipJensClipCE JensReliveJensReliveJensReliveJensReliveJensRelive SimuLockSimuLockSimuLockSimuLock 導管鞘產品NMPA JeniGal抗鈣化技術 幹瓣與高分子瓣葉技術TAVRTMVRTTVR 上市規則第18A.08(3)條規定的警告聲明： Ken-ValveLuX-Valve PlusJensClip ••204182567552 (GB/T 29490-2023) 7,000GMP ISO13485 LuX-ValveKen-ValveKOL Ken-Valve2690LuX-Valve PCRTEE Masterclass33(ASCVTS)TCT Plus Middle East 2025(SYDNEY VALVES 2025)CSC(StructuralCSC)AVAM 202519(ANZET 2025)SOLACI-SOCIME 20252025(CSHC 2025)20252025 HCIC2025China Valve(Hangzhou)(OCC 2025)2025(GBA Valve 2025)26(SCC)TAVR²S •LuX-Valve•LuX-Valve Plus•• II.財務回顧 13.4 1.6 11.8100%88.1% 3.8 (i)(ii)(iii)(iv)(v)17.012.1 (i)(ii)(iii)(iv)(v)vi) 82.288.911.736.224.570.552.717.8 (i)(ii)(iii)(iv)(v)vi) 35.357.42.635.432.932.722.010.7 (i)(ii)(iii)(iv)(v)(vi) 5.144.0 141,000138,000 105.8170.394.291.8 92.7 10.0 8.2 495.4606.0110.6 621.7552.2 21.56.0 (1)(2)(3)100% 54.215.838.460.3 4.13.4 13.7 567.3707.5140.2 24.115.8 人力資源 174 HH 中期股息 全球發售所得款項淨額用途 206.4 董事、監事及最高行政人員於本公司及其相聯法團股份、相關股份及債權證中的權益及淡倉 XV(i)XV78(ii)352(iii) (1)L417,167,290 寧波麟灃15,500,000H65.00%上海仕地 11,810,4485,875,512H (4)海南脈迪寧波桑迪25,414,271H13,413,822H98% (5)寧波沐康寧波鈳灃12,945,42020H8,441,848H98% (6)海南華翎16,363,62016,363,620H 海南華暉海南一則14,716,059H 99% (i)XV78(ii)352(iii) 主要股東於股份及相關股份的權益及淡倉 XV23336 (1)L417,167,290(2)15,500,000H65.00%11,810,4485,875,512H19,374,400H(3)25,414,271H13,413,822H98%(4)12,945,42020H8,441,848H98%(5)19,627,920220,000H(6)AUT-VII HK Holdings Limited10,875,000HAUT-VII HOLDINGS LIMITED100%AUT-VII HK Holdings LimitedHillhouse Fund V, L.P.TNY Holdings Limited20,850,000HHillhouse Fund V, L.P.(7)(8)16,363,62016,363,620H14,716,059H99%Onez International LimitedOnez International Limited 336 H股計劃 HHH17.12HA 17.12H (a)H H (i) (ii) (iii)(a)(b)(c) (b)H HHHHHHHHH股計劃規則HH33 (c)H HHHHH HH 退還股份H (d)H HHH31,030,620H HHH10.00%7.44%HHH31,030,620HH股計劃上限H選定參與者H HHHHH (e)H H合資格參與者 H H (a)12 (b)12 (c) (d) HH (f) (i) (ii)H (iii) (iv)H (v)H (vi)XIVA13.09(2)(a)XIVA (vii)60 (viii)30 (g) (A) HH歸屬期 H (B) (h) (a) (b)HH 38,600H0.01%H176,000164,000 H31,030,620938,820H 1.9,233,4353.65 企業管治措施 C1C.2.1 C.2.1C.2.1 遵守進行證券交易的標準守則 C3 購買、出售或贖回上市證券 董事會以及董事、最高行政人員及監事資料變動 13.51B (1) 審閱中期業績及中期報告 根據上市規則的持續披露責任 13.2013.2113.22 報告期後事項 寧波健世科技股份有限公司潘斐先生 1公司及集團資料 777 (i)(ii) 2編製基準 34 3會計政策及披露變動 21 21 4經營分部資料 5收入 6除稅前虧損 7所得稅 (a)25%(b)16.5%(c)25.8%(d)29.8% 8股息 9母公司普通股權益持有人應佔每股虧損 408,934,000413,015,000 176,000164,000 10物業、廠房及設備 6,719,00020,033,000 11貿易