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。 補體參與介導的腎臟疾病（Complement - mediated kidney disease,「CMKD」）是一類由 補體系統異常激活直接或間接介導的腎臟疾病，涵蓋多種原發性和繼發性腎小球疾病。 根據發病機制，CMKD可分為兩大類：（1）由補體系統異常活化直接介導的腎病，包 括C3腎小球病（C3 glomerulopathy, 「C3G」）、非典型溶血尿毒癥綜合徵、免疫複合 * 僅供識別 1 自願性及業務進展公告 創新藥補體因子B抑制劑CMS-D017 獲得補體參與介導的腎臟疾病適應症 藥物臨床試驗批准通知書 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，於二零二六年二月三日，本集團自主研發的創新藥CMS-D017膠囊 （「CMS-D017」或「產品」）獲得中國國家藥品監督管理局（「NMPA」）簽發的藥 物臨床試驗批准通 ...

CMS-D017是一种新型选择性补体因子B小分子抑制剂。补体系统是先天免疫系统的重要组成部分，可 通过经典途径、凝集素途径和旁路途径被激活从而发挥生物学功能。补体因子B是一种主要由肝脏合成 的特异性丝氨酸蛋白酶，是补体旁路途径中的「核心开关」和「效应放大器」，其活性直接影响补体反 应的强度。CMS-D017通过靶向抑制补体因子B，阻止补体旁路途径的异常活化，减低膜攻击复合物对 靶组织和器官的损伤，缓解补体失调相关疾病的进展。CMS-D017在临床前研究中表现出优异的有效性 和安全性，临床拟用于治疗阵发性睡眠性血红蛋白尿症。CMS-D017未来还拟开发用于治疗补体参与介 导的肾脏疾病、年龄相关性黄斑变性和重症肌无力等疾病。 康哲药业(00867)公布，于2026年1月30日，集团自主研发的创新药CMS-D017胶囊获得中国国家药品监 督管理局(NMPA)签发的药物临床试验批准通知书。NMPA同意集团在中国健康参与者中开展评价CMS- D017安全性、耐受性、药代动力学和药效动力学特徵的临床试验。 ...

CMS-D017是一种新型选择性补体因子B小分子抑制剂。补体系统是先天免疫系统的重要组成部分，可 通过经典途径、凝集素途径和旁路途径被激活从而发挥生物学功能。补体因子B是一种主要由肝脏合成 的特异性丝氨酸蛋白酶，是补体旁路途径中的"核心开关"和"效应放大器"，其活性直接影响补体反应的 强度。CMS-D017通过靶向抑制补体因子B，阻止补体旁路途径的异常活化，减低膜攻击复合物对靶组 织和器官的损伤，缓解补体失调相关疾病的进展。CMS-D017在临床前研究中表现出优异的有效性和安 全性，临床拟用于治疗阵发性睡眠性血红蛋白尿症。CMS-D017未来还拟开发用于治疗补体参与介导的 肾脏疾病、年龄相关性黄斑变性和重症肌无力等疾病。 康哲药业(00867)公布，于2026年1月30日，集团自主研发的创新药CMS-D017胶囊获得中国国家药品监 督管理局(NMPA)签发的药物临床试验批准通知书。NMPA同意集团在中国健康参与者中开展评价CMS- D017安全性、耐受性、药代动力学和药效动力学特徵的临床试验。 ...

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。 * 僅供識別 1 自願性及業務進展公告 創新藥補體因子B抑制劑CMS-D017 獲得陣發性睡眠性血紅蛋白尿症適應症 藥物臨床試驗批准通知書 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，於二零二六年一月三十日，本集團自主研發的創新藥CMS-D017膠囊 （「CMS-D017」或「產品」）獲得中國國家藥品監督管理局（「NMPA」）簽發的藥 物臨床試驗批准通知書。NMPA同意本集團在中國健康參與者中開展評價CMS-D017安 全性、耐受性、藥代動力學和藥效動力學特徵的臨床試驗。 CMS-D017是一種新型選擇性補體因子B小分子抑制劑。補體系統是先天免疫系統的重 要組成部分，可通過經典途徑、凝集素途徑和旁路途徑被激活從而發揮生物學功能。補 體因子B是一種主要由肝臟合成的特異性絲氨酸蛋白酶，是補體旁路途徑中的「核心開 關」和「效應放 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received a notice of acceptance from the National Medical Products Administration for the market approval application of HRS-5965 capsules, a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) [1][2] Group 1: Product Development - The application for HRS-5965 is based on a pivotal study involving PNH patients who had not previously received complement inhibitor treatment [1] - The study, HRS-5965-301, is a Phase III clinical trial comparing HRS-5965 capsules with Eculizumab in treating PNH patients, involving 76 patients across 13 centers in China [1] - Results indicate that HRS-5965 significantly improves hemoglobin levels, reduces the need for blood transfusions, and alleviates fatigue compared to Eculizumab, enhancing patients' quality of life [1] Group 2: Market Context - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis [2] - HRS-5965 is a complement factor B inhibitor that can suppress complement-mediated hemolytic reactions and improve hemoglobin levels [2] - Currently, the only approved drug targeting this indication is Novartis's Iptacopan (Fabhalta), with projected global sales of approximately $129 million in 2024 [2] - The cumulative R&D investment for HRS-5965 has reached approximately 218 million yuan [2]

Core Insights - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Rivolumab tablets, a second-generation AR inhibitor, which is expected to enhance treatment for metastatic hormone-sensitive prostate cancer [1][2] - The company’s subsidiary, Chengdu Shengdi Pharmaceutical Co., has its HRS-5965 capsules listed for priority review, targeting adult patients with paroxysmal nocturnal hemoglobinuria (PNH) [1][2] Group 1: Rivolumab Tablets - Rivolumab tablets are a second-generation AR inhibitor with stronger AR suppression and no agonistic effects compared to first-generation inhibitors [1] - The global sales of similar products are projected to reach approximately $11.037 billion in 2024 [1] - Cumulative R&D investment for Rivolumab tablets has reached about 693 million yuan [1] Group 2: HRS-5965 Capsules - HRS-5965 capsules are a complement factor B inhibitor designed to treat PNH, a rare acquired hemolytic disease [2] - The global sales for HRS-5965 are estimated to be around $12.9 million in 2024 [2] - Cumulative R&D investment for HRS-5965 has reached approximately 210 million yuan [2] Group 3: Share Buyback Program - Heng Rui Medicine has repurchased 7.9188 million shares, accounting for 0.12% of the total share capital, with a total expenditure of 535 million yuan [2][3] - The buyback program was approved in August, with a maximum purchase price of 90.85 yuan per share and a total budget between 1 billion and 2 billion yuan [3] - The buyback period is set for 12 months from the board's approval date [3]