Core Viewpoint - Kangzheng Pharmaceutical has received approval from the National Medical Products Administration (NMPA) for clinical trials of its innovative drug CMS-D017, which targets complement-mediated kidney diseases [1][2]. Group 1: Product Overview - CMS-D017 is a novel selective small molecule inhibitor of complement factor B, which plays a crucial role in the complement system, a key component of the innate immune system [2]. - The drug aims to inhibit the abnormal activation of the complement pathway, thereby reducing damage to target tissues and organs associated with complement dysregulation-related diseases [2]. - CMS-D017 has shown excellent efficacy and safety in preclinical studies and is intended for the treatment of various complement-mediated kidney diseases, including IgA nephropathy, idiopathic membranous nephropathy, lupus nephritis, and C3 glomerulopathy [2][3]. Group 2: Clinical Need and Market Potential - Complement-mediated kidney diseases (CMKD) encompass a range of primary and secondary glomerular diseases, with IgA nephropathy and idiopathic membranous nephropathy being prevalent in China [3]. - Current treatment options, such as steroids and immunosuppressants, have significant limitations, including limited efficacy and notable side effects, indicating a substantial unmet clinical need [3]. - Targeting complement factor B is considered an effective therapeutic approach for CMKD, and CMS-D017 may provide a superior treatment option for patients [3]. Group 3: Strategic Implications for the Company - If approved for market launch, CMS-D017 will enhance the company's strength in the kidney disease treatment sector, complementing its other innovative drugs, such as Vifor (for CKD-related hyperphosphatemia) and Dexamethasone (for renal anemia) [4]. - The synergy between CMS-D017 and existing products is expected to improve the company's competitive position and market presence in the nephrology field [4]. - The company is actively preparing to initiate clinical trial work to expedite the product's market entry [5].

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 ...

Core Viewpoint - Kangzheng Pharmaceutical (00867) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its innovative drug CMS-D017, which is a selective complement factor B small molecule inhibitor aimed at treating complement-mediated diseases [1] Group 1: Drug Development - CMS-D017 has been approved for clinical trials to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants in China [1] - The drug targets complement factor B, a key component in the complement system, which is crucial for innate immunity and can be activated through various pathways [1] - CMS-D017 aims to prevent abnormal activation of the complement pathway, thereby reducing damage to target tissues and organs associated with complement dysregulation [1] Group 2: Clinical Applications - The drug is primarily intended for the treatment of paroxysmal nocturnal hemoglobinuria, with potential future applications in treating complement-mediated kidney diseases, age-related macular degeneration, and myasthenia gravis [1] - Preclinical studies have demonstrated excellent efficacy and safety for CMS-D017, indicating a promising future for its clinical use [1]

Core Viewpoint - Kangzheng Pharmaceutical (00867) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its innovative drug CMS-D017, which is a selective complement factor B small molecule inhibitor aimed at treating complement-mediated diseases [1] Group 1: Drug Development - CMS-D017 has been granted a clinical trial approval notice by NMPA to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants in China [1] - The drug targets complement factor B, a key component in the complement system, which is crucial for innate immunity and can be activated through various pathways [1] - CMS-D017 aims to prevent abnormal activation of the complement pathway, thereby reducing damage to target tissues and organs associated with complement dysregulation [1] Group 2: Clinical Applications - The drug has shown excellent efficacy and safety in preclinical studies and is intended for the treatment of paroxysmal nocturnal hemoglobinuria [1] - Future development plans for CMS-D017 include potential applications in treating complement-mediated kidney diseases, age-related macular degeneration, and myasthenia gravis [1]

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]