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。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥磷酸蘆可替尼乳膏AD適應症中國三期藥物臨床研究取得積極結果 有關AD AD是一種慢性、復發性、炎症性的皮膚疾病，臨床主要表現為皮膚乾燥、慢性濕疹樣皮 損和明顯瘙癢，可能嚴重影響患者的生活品質。據估算，2024年中國特應性皮炎患者超 過5,400萬人，基於SCORAD評分，輕度、中度、重度特應性皮炎的占比分別為73%、25% 和2%。外用藥物是AD最基本的治療方法。傳統外用藥物如外用糖皮質激素（TCS）及外 用鈣調神經磷酸酶抑制劑（TCIs）有長期用藥的不良反應或療效有限的臨床痛點，臨床 亟需新的治療選擇。 China Medical System Holdings Limited（「本公司」，連同 ...

CMS-D002是小分子促性腺激素釋放激素（GnRH）受體拮抗劑。GnRH是由下丘腦神經 內分泌細胞合成的十肽激素，是調控生殖系統激素釋放的重要因子。CMS-D002與內源 性GnRH競爭性結合垂體上的GnRH受體，在中樞神經水平阻斷垂體性腺軸，減少內源性 促卵泡刺激素（FSH）和促黃體生成素（LH）的釋放，從而抑制下遊雌激素、黃體酮和 睾酮的分泌，緩解性激素相關疾病的進展。CMS-D002在臨床前研究中表現出優異的有 效性和安全性。此前，CMS-D002已於二零二四年二月六日，獲得NMPA簽發的藥物臨 床試驗批准通知書，本集團正在穩步推進子宮內膜異位症的I期臨床研究。近日， CMS-D002再次獲得NMPA批准臨床試驗，適應症範圍新增子宮肌瘤適應症。除子宮內 膜異位症及子宮肌瘤外，CMS-D002未來可開發用於治療前列腺癌等疾病。 子宮肌瘤（Uterine fibroids, UFs）由子宮平滑肌組織增生而形成，是女性最常見的一種 良性腫瘤，其病因尚不明確，可能與遺傳易感性和性激素水準有關，高危因素包括年齡、 種族、肥胖和飲食等。UFs發病年齡在15至59歲之間，以30至44歲的女性最為常見，發 病率整體呈 ...

本报讯(记者李雯珊)9月22日，康哲药业控股有限公司(以下简称"康哲药业")与重庆智翔金泰生物制药股 份有限公司(以下简称"智翔金泰")签订独家合作协议，获得两款1类治疗用生物制品唯康度塔单抗 (GR2001)注射液和斯乐韦米单抗(GR1801)注射液在中国大陆的独家商业化权与除中国大陆之外的亚太 地区及中东、北非的独家许可权。 唯康度塔单抗是一款安全性佳，且优效于破伤风人免疫球蛋白(HTIG)，可为患者提供快速且持久保护 的破伤风被动免疫制剂。产品中国Ⅲ期临床试验达到了主要疗效终点。2024年5月，产品被国家药品监 督管理局(NMPA)药品审评中心(CDE)纳入突破性治疗品种名单，其新药上市申请(NDA)已于2025年5月 获得CDE受理，有望成为中国第二个获批的破伤风被动免疫单抗。 斯乐韦米单抗是全球首款针对狂犬病毒糖蛋白表位Ⅰ和/或Ⅲ的重组全人源抗狂犬病病毒(RABV)双特异 性抗体，符合世界卫生组织(WHO)建议开发的针对不同抗原位点的"鸡尾酒式"疗法，可大规模标准化稳 定生产，并且中和谱广、免疫原性低、对疫苗主动免疫干扰小、成本可控。2025年1月14日，其用于成 人疑似狂犬病病毒暴露后的被动免疫适 ...

Core Insights - Kangzheng Pharmaceutical Holdings Limited has signed an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. for two innovative biological agents aimed at infectious disease prevention, obtaining exclusive commercialization rights in mainland China and exclusive licensing rights in the Asia-Pacific region, the Middle East, and North Africa [1] Group 1: Product Details - Weikangduta Monoclonal Antibody (GR2001) is a recombinant humanized monoclonal antibody that provides rapid and long-lasting protection against tetanus, outperforming human tetanus immunoglobulin (HTIG) [2] - The product targets the C-terminal heavy chain of tetanus toxin (TeNT-Hc), blocking its entry into neuronal cells, and has achieved primary efficacy endpoints in Phase III clinical trials [2] - The NDA for Weikangduta Monoclonal Antibody was accepted by the National Medical Products Administration (NMPA) on May 22, 2025, and it was included in the list of breakthrough therapies by the NMPA in May 2024 [2] Group 2: Market Potential - Sileweimi Monoclonal Antibody (GR1801) is the world's first recombinant fully human bispecific antibody for passive immunity against rabies, designed to block the rabies virus from infecting neurons before the rabies vaccine can take effect [3] - The product can be produced in a standardized and stable manner, with broad neutralization spectrum, low immunogenicity, minimal interference with vaccine-induced immunity, and controllable costs [3] - The NDA for Sileweimi Monoclonal Antibody for adults was accepted by the NMPA on January 14, 2025, and clinical trial applications for children aged 2 to 18 were approved in July 2025, with ongoing Phase III clinical trials [3] Group 3: Strategic Focus - Kangzheng Pharmaceutical is committed to developing innovative products with clinical value and differentiated advantages, addressing the limitations of existing passive immunization agents in terms of safety and accessibility [3] - The approval and market launch of Weikangduta and Sileweimi Monoclonal Antibodies are expected to provide new passive immunization options for patients exposed to tetanus and rabies, leveraging the company's existing market resources and expert networks [3]

Group 1 - Huadong Medicine's subsidiary received FDA approval for the clinical trial of HDM2017, a new antibody-drug conjugate targeting Cadherin 17, for advanced malignant solid tumors [1] - Tianjin Pharmaceutical's subsidiary obtained approval for the new indication of Pu You Ke for thrombolytic treatment of acute ischemic stroke, making it the only approved recombinant human urokinase product in China [2] - Yabao Pharmaceutical decided to terminate the clinical trial of SY-009 and fully provision for asset impairment of 55.793 million yuan, which will reduce the company's profit for 2025 [3] Group 2 - Zhixiang Jintai signed exclusive cooperation agreements with Kangzhe Pharmaceutical for the commercialization of GR2001 and GR1801 monoclonal antibodies, with expected payments totaling approximately 510 million yuan [4] - Lepu Medical established a strategic partnership with Hanhai Information to jointly develop the medical aesthetics business, aiming to enhance sales channels and improve performance amid industry competition [5][6]

Core Viewpoint - The announcement of an exclusive cooperation agreement between Zhixiang Jintai and Kangzhe Pharmaceutical is expected to significantly enhance the company's market position and financial performance through the commercialization of two monoclonal antibodies [1][2]. Group 1: Agreement Details - Zhixiang Jintai signed an exclusive cooperation agreement with Kangzhe Pharmaceutical and its subsidiaries, which includes a total payment of up to 260 million RMB, consisting of upfront and milestone payments [1]. - The agreement grants Zhixiang Jintai exclusive commercialization rights for Weikang Duta monoclonal injection and Sileweimi monoclonal injection in mainland China and the Asia-Pacific region [1]. Group 2: Market Impact - Following the announcement, Zhixiang Jintai's stock price rose by 1.41% to 33.79 RMB per share, with a trading volume of 129 million RMB, reflecting positive market sentiment [2]. - Despite a slight decline of 0.18% in the stock price over the past seven trading days, the announcement has boosted investor confidence and increased attention on the company [2]. Group 3: Strategic Outlook - The cooperation is seen as a strategic move to enhance Zhixiang Jintai's market competitiveness and position within the biopharmaceutical industry, responding proactively to future market demands [1][4]. - The company aims to deepen resource integration with key partners, enhance R&D capabilities, and optimize product structure to drive overall transformation and long-term growth [4].

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].

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 injections: GR2001 for passive immunity against tetanus and GR1801 for passive immunity post-suspected rabies virus exposure, with exclusive rights in mainland China and other regions [1][2]. Group 1: Product Details - GR2001 is a recombinant humanized monoclonal antibody targeting the C-terminal of Tetanus Neurotoxin (TeNT), which has shown efficacy in phase III clinical trials and is included in the NMPA's list of breakthrough therapies [2][3]. - GR1801 is a recombinant fully human bispecific antibody targeting the rabies virus glycoprotein, designed to provide immediate protection against rabies post-exposure, and has also met primary efficacy endpoints in phase III trials [4][5]. Group 2: Market Context - Tetanus cases globally are estimated between 500,000 to 1,000,000 annually, with a high mortality rate, particularly among the elderly and infants, highlighting the need for effective preventive treatments [3]. - Rabies is a highly fatal disease with nearly 100% mortality once symptoms appear, necessitating effective post-exposure prophylaxis, which includes the use of passive immunization agents [5][6]. Group 3: Competitive Landscape - Current passive immunization options for tetanus and rabies have significant limitations in safety and accessibility, creating a market opportunity for GR2001 and GR1801, which promise improved safety profiles and efficacy [3][6]. - GR1801 is positioned as the first globally approved bispecific antibody for rabies passive immunity, aligning with WHO recommendations for a "cocktail" approach to enhance efficacy against various virus strains [4][6].

Core Viewpoint - The company has signed exclusive collaboration agreements for two monoclonal antibody products, GR2001 and GR1801, which target passive immunity for tetanus and rabies, respectively, with a focus on commercialization in mainland China and the Asia-Pacific region, as well as the Middle East and North Africa [1][2]. Group 1: Product Details - GR2001 is a recombinant humanized monoclonal antibody targeting the C-terminal of Tetanus Neurotoxin (TeNT), providing passive immunity by blocking TeNT from entering neuronal cells [2]. - GR1801 is a recombinant fully human bispecific antibody targeting the glycoprotein of the rabies virus, preventing the virus from infecting neurons before the active immunity from rabies vaccination takes effect [2]. Group 2: Market Potential and Strategic Positioning - The passive immunity market for tetanus and rabies is significant, with existing products having limitations in safety and accessibility [3]. - GR2001 offers better safety and efficacy compared to human tetanus immunoglobulin (HTIG), providing rapid and long-lasting protection for patients [3]. - GR1801 is the first globally to target specific epitopes of the rabies virus glycoprotein, aligning with WHO development recommendations, and is designed for large-scale standardized production [3]. - If approved, both products are expected to provide new treatment options for patients in China and positively impact the company's performance through synergy with existing products [3].

智翔金泰表示，根据协议，公司将获得首付款、里程碑付款约5.1亿元，并获得其商业化推广等服务， 西藏康哲将获得上述两款产品在中国大陆的独家商业化权，RXILIENT将获得上述两款产品除中国大陆 之外的亚太地区及中东、北非的独家许可权。 北京商报讯（记者 丁宁）9月22日晚间，智翔金泰（688443）发布公告称，公司与康哲药业控股有限公 司之附属公司西藏康哲药业发展有限公司（以下简称"西藏康哲"）和RXILIENT MEDICAL PTE. LTD.就 唯康度塔单抗注射液（GR2001注射液）以及斯乐韦米单抗注射液（GR1801注射液）分别签订独家合作 协议。 ...