公告称，此次申报上市，是基于一项在既往未接受过补体抑制剂治疗的PNH患者中进行的关键研究 (HRS-5965-301)。该研究是一项评估HRS-5965胶囊对比依库珠单抗用于治疗既往未接受过补体抑制剂 治疗的PNH患者的Ⅲ期临床研究，由中国医学科学院血液病医院张凤奎教授和中国医学科学院北京协和 医院韩冰教授担任主要研究者，全国共13家中心共同参与，共计76例患者入组用药。 据了解，富马酸立康可泮胶囊是恒瑞医药自主研制的1类新药。公告显示，截至目前，HRS-5965胶囊相 关项目累计研发投入约2.18亿元。 中证报中证网讯(记者李梦扬)1月9日晚间，恒瑞医药（600276）公告，近日，公司子公司成都盛迪医药 有限公司收到国家药品监督管理局下发的《受理通知书》，公司富马酸立康可泮(HRS-5965)胶囊的药品 上市许可申请获国家药监局受理，适应症为：治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋 白尿症(PNH)成人患者。 ...

证券日报网讯 1月9日，恒瑞医药在互动平台回答投资者提问时表示，公司按要求定期披露股东户数， 敬请留意定期报告相关内容。 （文章来源：证券日报） ...

智通财经APP获悉，香港联交所最新资料显示，1月6日，小摩增持恒瑞医药(01276)112.7828万股，每股 作价74.6126港元，总金额约为8415.02万港元。增持后最新持股数目约为1919.4万股，最新持股比例为 7.43%。 ...

香港联交所最新资料显示，1月6日，小摩增持恒瑞医药（600276）(01276)112.7828万股，每股作价 74.6126港元，总金额约为8415.02万港元。增持后最新持股数目约为1919.4万股，最新持股比例为 7.43%。 ...

（编辑 丛可心） 证券日报网讯 1月9日，恒瑞医药在互动平台回答投资者提问时表示，公司坚持科技创新与国际化两大 发展战略，创新成果转化高效赋能，创新药销售引领业绩增长。2025年上半年，公司创新药销售及许可 收入95.61亿元，占公司营业收入比重60.66%。此外，公司自2023年以来达成12笔创新成果对外授权， 潜在总交易额超270亿美元。公司将继续大力推进"科技创新"和"国际化"两大发展战略，稳步推进研发 创新和制剂产品的国际化。同时，也将着力于产品结构的优化提升，通过产品创新升级和多元化产品管 线的拓展推动公司的持续发展，促进公司业绩可持续增长，以更好的发展回馈股东。 ...

证券日报网讯1月9日，恒瑞医药（600276）在互动平台回答投资者提问时表示，二级市场股价受宏观经 济、市场情绪等多重因素影响。公司将继续大力推进"科技创新"和"国际化"两大发展战略，稳步推进研 发创新和制剂产品的国际化。同时，也将着力于产品结构的优化提升，通过产品创新升级和多元化产品 管线的拓展推动公司的持续发展，促进公司业绩可持续增长，以更好地发展回馈股东。 ...

证券日报网讯1月9日，恒瑞医药（600276）在互动平台回答投资者提问时表示，公司前瞻性地广泛布局 多个治疗领域，并向纵深发展。公司在肿瘤领域有丰富的研发管线，与此同时，在代谢和心血管疾病、 免疫和呼吸系统疾病、神经科学等领域也进行了广泛布局，打造长期发展的多元化战略支柱。公司坚持 差异化研发策略，以临床需求为导向，利用领先的技术平台开发了高度差异化的创新产品矩阵，未来将 稳步加快全球拓展，进一步深化对外合作，积极拓展海外研发边界，同时进一步强化在国内外市场的商 业化能力，最大化挖掘优质创新产品的全球市场潜力。 ...

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received a notice of acceptance from the National Medical Products Administration for the marketing authorization application of HRS-5965 capsules, a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) [1][2] Group 1: Company Developments - The application for HRS-5965's market approval is based on a pivotal study involving PNH patients who had not previously received complement inhibitor treatment [1] - The clinical study (HRS-5965-301) was a Phase III trial comparing HRS-5965 capsules with Eculizumab in treating PNH patients, led by prominent researchers from the Chinese Academy of Medical Sciences [1] - The study included 76 patients across 13 centers nationwide, showing that HRS-5965 significantly improved hemoglobin levels, reduced the need for blood transfusions, and enhanced quality of life compared to Eculizumab [1] Group 2: Industry Context - PNH is a rare acquired hemolytic disease characterized by the deficiency of CD55 and CD59, leading to complement-mediated intravascular hemolysis, and has been included in the national rare disease directory due to its low incidence/prevalence [2] - HRS-5965 capsules act as a complement factor B inhibitor, which can suppress complement-mediated hemolysis and improve hemoglobin levels [2] - Currently, the only other drug targeting this indication is Novartis's Iptacopan (Fabhalta), which is projected to generate global sales of approximately $129 million in 2024 [2] - The cumulative R&D investment for HRS-5965 capsules has reached approximately 218 million yuan [2]

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]

申报阶段：上市 格隆汇1月9日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司子公司成都盛迪医药有限 公司收到国家药品监督管理局下发的《受理通知书》，公司富马酸立康可泮（HRS-5965）胶囊的药品 上市许可申请获国家药监局受理。 药品名称：富马酸立康可泮胶囊 剂型：胶囊剂 受理号：CXHS2600014 申请人：成都盛迪医药有限公司 拟定适应症（或功能主治）：治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH） 成人患者。 ...