证券代码：600196 股票简称：复星医药 编号：临 2025-144 上海复星医药（集团）股份有限公司 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、概况 上海复星医药（集团）股份有限公司（以下简称"本公司"）控股子公司复星 万邦（江苏）医药集团有限公司（以下简称"复星万邦"）于近期收到国家药品监 督管理局（以下简称"国家药监局"）关于同意丁二酸复瑞替尼胶囊（项目代号： SAF-189，申请注册分类：化药 1 类；以下简称"该新药"）用于间变性淋巴瘤激酶 （ALK）阳性或者 c-ros 肉瘤致癌因子-受体酪氨酸激酶（ROS1）阳性的 IB 期至ⅢA 期非小细胞肺癌患者肿瘤根治性切除术后的辅助治疗开展临床试验的批准。复星万 邦拟于条件具备后于中国境内（不包括港澳台地区，下同）开展该新药的Ⅲ期临床 试验。 二、该新药的基本信息及研究情况 三、风险提示 关于控股子公司药品获临床试验批准的公告 该新药为创新型小分子化学药物，拟主要用于治疗非小细胞肺癌(ALK+)、非小 细胞肺癌（ROS1+）等。该新药由本公司控股子公司重庆复创 ...

证券代码：600196 股票简称：复星医药 编号：临 2025-145 上海复星医药（集团）股份有限公司 关于控股子公司药品获美国 FDA 临床试验批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、概况 上海复星医药（集团）股份有限公司（以下简称"本公司"）控股子公司上海复 宏汉霖生物技术股份有限公司及其控股子公司（以下合称"复宏汉霖"）于近日获美 国 FDA（即美国食品药品监督管理局）批准开展 HLX17（即重组抗 PD-1 人源化单克 隆抗体注射液，以下简称"HLX17"）用于治疗多种已切除实体瘤患者的 I 期临床试 验。复宏汉霖拟于条件具备后于美国开展该国际多中心临床研究。 二、HLX17 的研究情况 HLX17 为本集团（即本公司及控股子公司/单位，下同）自主研发的帕博利珠单 抗生物类似药，潜在适应症包括黑色素瘤、非小细胞肺癌、食管癌、头颈部鳞状细 胞癌、结直肠癌、肝细胞癌、胆道癌、三阴性乳腺癌、微卫星高度不稳定型或错配 修复基因缺陷型肿瘤、胃癌等原研药已获批适应症。2024 年 9 月，HLX17 相关 ...

格隆汇9月8日丨复星医药(600196.SH)公布，公司控股子公司复星万邦(江苏)医药集团有限公司(称"复星 万邦")于近期收到国家药品监督管理局关于同意丁二酸复瑞替尼胶囊(项目代号：SAF-189，申请注册分 类：化药1类;称"该新药")用于间变性淋巴瘤激酶(ALK)阳性或者c-ros肉瘤致癌因子-受体酪氨酸激酶 (ROS1)阳性的IB期至ⅢA期非小细胞肺癌患者肿瘤根治性切除术后的辅助治疗开展临床试验的批准。复 星万邦拟于条件具备后于中国境内(不包括港澳台地区，下同)开展该新药的Ⅲ期临床试验。 ...

格隆汇9月8日丨复星医药(600196.SH)公布，公司控股子公司复星万邦(江苏)医药集团有限公司(称"复星 万邦")于近期收到国家药品监督管理局关于同意丁二酸复瑞替尼胶囊(项目代号：SAF-189，申请注册分 类：化药1类;称"该新药")用于间变性淋巴瘤激酶(ALK)阳性或者c-ros肉瘤致癌因子-受体酪氨酸激酶 (ROS1)阳性的IB期至ⅢA期非小细胞肺癌患者肿瘤根治性切除术后的辅助治疗开展临床试验的批准。复 星万邦拟于条件具备后于中国境内(不包括港澳台地区，下同)开展该新药的Ⅲ期临床试验。 ...

复星医药公告，控股子公司复宏汉霖生物及其子公司于近日获美国FDA批准开展HLX17用于治疗多种 已切除实体瘤患者的I期临床试验。HLX17为集团自主研发的帕博利珠单抗生物类似药，潜在适应症包 括黑色素瘤、非小细胞肺癌、食管癌等。 ...

复星医药公告，控股子公司复星万邦（江苏）医药集团有限公司于近期收到国家药品监督管理局关于同 意丁二酸复瑞替尼胶囊用于间变性淋巴瘤激酶（ALK）阳性或者c-ros肉瘤致癌因子-受体酪氨酸激酶 （ROS1）阳性的IB期至ⅢA期非小细胞肺癌患者肿瘤根治性切除术后辅助治疗开展临床试验的批准。 复星万邦拟于条件具备后于中国境内开展该新药的Ⅲ期临床试验。截至2025年7月，本集团针对该新药 的累计研发投入约为4.53亿元。 ...

每经AI快讯，9月8日，复星医药（600196）(600196.SH)公告称，公司控股子公司复宏汉霖获得美国 FDA批准开展HLX17(重组抗PD-1人源化单克隆抗体注射液)用于治疗多种已切除实体瘤患者的I期临床 试验。HLX17为本集团自主研发的帕博利珠单抗生物类似药，潜在适应症包括黑色素瘤、非小细胞肺 癌等。 ...

Core Insights - Recently, Dr. Wang Xingli, Co-President of Fosun Pharma and CEO of the Global R&D Center, visited the Shanghai headquarters of Ruizhi Pharmaceutical Technology Co., Ltd. for discussions [1] - The meeting focused on technological innovation in the biopharmaceutical R&D field and the development direction of new modality drugs, further deepening the cooperation consensus between the two companies [1] Company Collaboration - The visit signifies a strategic partnership aimed at enhancing collaboration in biopharmaceutical research and development [1] - Both companies are committed to exploring innovative solutions and advancing drug development processes [1]

Core Viewpoint - Fosun Pharma has transformed from a generic drug company to a high-level innovative enterprise, focusing on innovation and global expansion, reflecting the shift of China's pharmaceutical industry from a follower to a leader in innovation [2] Financial Performance - In the first half of 2025, Fosun Pharma achieved revenue of 19.514 billion yuan and a net profit attributable to shareholders of 1.702 billion yuan, representing a year-on-year growth of 38.96% [2] - Revenue from innovative drugs exceeded 4.3 billion yuan, with a year-on-year increase of 14.26%, driven by product structure optimization and sales growth [2] Innovation Strategy - The company has approved 4 innovative drugs (covering 5 indications) and 57 generic drugs during the reporting period, with 4 innovative drugs and 22 generic drugs submitted for market approval [3] - Fosun Pharma emphasizes the importance of innovation in drug development efficiency, speed to market, and commercialization [4] Global Expansion - In the first half of 2025, overseas revenue reached 5.478 billion yuan, accounting for approximately 28.07% of total revenue [5] - The company has established a clinical operations team in the U.S. for the commercialization of innovative products and has set up regional distribution centers in emerging markets [5][6] Business Development - Fosun Pharma's innovative pipeline quality has improved, leading to increased business development activities and global licensing cooperation [6] - The company has achieved significant international recognition for its PD-1 monoclonal antibody, with approvals in over 30 countries and regions [6] Strategic Focus - The company is implementing a new A+H share equity incentive plan, with core performance indicators focusing on net profit and innovative drug revenue [4] - Fosun Pharma aims for a compound annual growth rate of approximately 20% in innovative drug revenue from 2025 to 2027 [4] Long-term Vision - The company is committed to its 4IN strategy: Innovation, Internationalization, Intelligentization, and Integration, aiming to enhance innovation speed and quality, as well as global reach [8]

Core Viewpoint - Fosun Pharma has transformed from a generic drug company to a high-level innovative enterprise, focusing on innovation and global expansion, reflecting the shift of China's pharmaceutical industry from a follower to a leader in innovation [1] Financial Performance - In the first half of 2025, Fosun Pharma achieved revenue of 19.514 billion yuan and a net profit attributable to shareholders of 1.702 billion yuan, representing a year-on-year growth of 38.96% [1] - Revenue from innovative drugs exceeded 4.3 billion yuan, with a year-on-year increase of 14.26%, driven by product structure optimization and sales growth [1][2] Innovation Strategy - The company has approved 4 innovative drugs and 57 generic drugs during the reporting period, with 4 innovative drugs and 22 generic drugs submitted for market approval [2] - Fosun Pharma aims for a compound annual growth rate of approximately 20% in innovative drug revenue from 2025 to 2027, linking this growth to the increase in net profit attributable to shareholders [2] Global Market Expansion - In the first half of 2025, overseas revenue reached 5.478 billion yuan, accounting for about 28.07% of total revenue, with a focus on building a commercial team in the U.S. for the launch of innovative products [3] - The company has established six regional distribution centers in emerging markets such as Africa and Southeast Asia, providing comprehensive services including drug registration and safety monitoring [3][4] Business Development and Licensing - Fosun Pharma has strengthened its global licensing cooperation, with significant progress in business development for innovative drugs, including the international recognition of its PD-1 monoclonal antibody, Surulitinib [4][5] - The company differentiates between license-in and license-out strategies to enhance its product pipeline and accelerate commercial deployment [5] Strategic Framework - Fosun Pharma adheres to the 4IN strategy: Innovation, Internationalization, Intelligentization, and Integration, aiming to enhance innovation speed and quality, global reach, and embrace AI [6]