Core Viewpoint - 康哲药业 has signed exclusive collaboration agreements with 重庆智翔金泰 for the commercialization of two monoclonal antibody products, 唯康度塔单抗 (GR2001) and 斯乐韦米单抗 (GR1801), targeting passive immunity for tetanus and rabies respectively, with exclusive rights in mainland China and other regions [1][2]. Group 1: Product Details - 唯康度塔单抗 is a recombinant humanized monoclonal antibody targeting the C-terminal of Tetanus Neurotoxin (TeNT), which blocks its entry into neurons, providing passive immunity [2]. - 斯乐韦米单抗 is a recombinant fully human bispecific antibody targeting the glycoprotein of Rabies Virus (RABV), preventing the virus from infecting neurons before the active immunity from rabies vaccine takes effect [2]. Group 2: Market Potential and Strategic Impact - The passive immunity market for tetanus and rabies is significant, with existing products having limitations in safety and accessibility [3]. - 唯康度塔单抗 offers better safety and efficacy compared to human tetanus immunoglobulin (HTIG), providing rapid and long-lasting protection [3]. - 斯乐韦米单抗 is the first globally to target specific epitopes of the rabies virus glycoprotein, aligning with WHO development recommendations, and is expected to be produced in a standardized and cost-effective manner [3]. - If approved, these products will provide new treatment options for patients in China and are anticipated to positively impact the company's performance through synergy with existing products [3].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 自願性及業務進展公告 就1類創新型治療用生物製品 重組人源化抗破傷風毒素單克隆抗體唯康度塔單抗注射液 及重組全人源抗狂犬病病毒雙特異性抗體斯樂韋米單抗注射液 簽訂合作協議 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本 集團」）欣然宣佈，於二零二五年九月二十二日，本集團通過本公司附屬公司與重慶智 翔金泰生物製藥股份有限公司（「智翔金泰」）就用於破傷風的被動免疫適應症的1類 治療用生物製品唯康度塔單抗（GR2001）注射液（「唯康度塔單抗注射液」）及用於疑 似狂犬病病毒暴露後的被動免疫適應症的1類治療用生物製品斯樂韋米單抗（GR1801） 注射液（「斯樂韋米單抗注射液」）分別簽訂獨家合作協議（「協議」）。 根據協議，本集團獲得了唯康度塔單抗注射液及斯樂韋米單抗注射液在中國大陸的獨家 商業化權與除中國大陸之外的亞太地區及中東、北非的獨家許可權。合作 ...