复星医药表示，该新药为创新型小分子化学药物。除本次申报适应症外，截至公告日期，该新药的另一 适应症非小细胞肺癌（ROS1+）于中国境内（不包括港澳台地区）也已完成 II 期临床研究。 北京商报讯（记者 丁宁）1月8日晚间，复星医药（600196）发布公告称，公司控股子公司复星万邦 （江苏）医药集团有限公司就丁二酸复瑞替尼胶囊再次递交的药品注册申请获国家药品监督管理局受 理，本次申报适应症为用于间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌 （NSCLC）患者的治疗。 ...

格隆汇1月8日丨复星医药(02196.HK)公告，近日，上海复星医药(集团)股份有限公司控股子公司复星万 邦(江苏)医药集团有限公司就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")再次递交的药品注册申请获国家药品监督管理局受理，本次申报适应症为用于间变性 淋巴瘤激酶(ALK)阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者的治疗。 截至2025年11月，集团(即公司及控股子公司/单位，下同)现阶段针对该新药的累计研发投入约为人民币 4.80亿元(未经审计)。根据IQVIACHPA最新数据，2024年，用于治疗非小细胞肺癌(ALK+)的主要药品 于中国境内的销售额约为人民币33.67亿元。 该新药为创新型小分子化学药物。除本次申报适应症外，截至本公告日期(即2026年1月8日)，该新药的 另一适应症非小细胞肺癌(ROS1+)于中国境内(不包括港澳台地区，下同)也已完成II期临床研究。 ...

北京商报讯（记者 王寅浩 宋雨盈）1月8日，复星医药发布公告称，公司控股子公司复星万邦（江苏） 医药集团有限公司就丁二酸复瑞替尼胶囊再次递交的药品注册申请获国家药品监督管理局受理，申报适 应症为用于间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治 疗。 ...

复星医药（600196）(02196)发布公告，近日，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)医药集团有限公司就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")再次递交的药品注册申请获国家药品监督管理局受理，本次申报适应症 为用于间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者的治疗。 ...

智通财经APP讯，复星医药(02196)发布公告，近日，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)医药集团有限公司就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")再次递交的药品注册申请获国家药品监督管理局受理，本次申报适 应症为用于间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者的治疗。 ...

人民财讯1月8日电，复星医药(600196)1月8日公告，近日，控股子公司复星万邦（江苏）医药集团有限 公司就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）再次递交的药品注册申 请获国家药品监督管理局受理，本次申报适应症为用于间变性淋巴瘤激酶（ALK）阳性的局部晚期或 转移性非小细胞肺癌（NSCLC）患者的治疗。 转自：证券时报 ...

格隆汇1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)医药集团有限公司就丁二酸 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")再次递交的药品注册申 请获国家药品监督管理局受理，本次申报适应症为用于间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移 性非小细胞肺癌(NSCLC)患者的治疗。 该新药为创新型小分子化学药物。除本次申报适应症外，截至本公告日期(即2026年1月8日)，该新药的 另一适应症非小细胞肺癌(ROS1+)于中国境内(不包括港澳台地区，下同)也已完成II期临床研究。 ...

Policy Developments - Guizhou Province is advancing the monitoring of adverse reactions to medical institution formulations, highlighting issues such as insufficient awareness and inadequate responsibility among institutions [1] - Liaoning Province is implementing a tiered management system for outpatient medical insurance settlements at designated medical institutions starting next year, aiming to improve the efficiency of medical insurance fund usage [2] Drug and Device Approvals - GlaxoSmithKline announced that the NMPA has approved the use of its Shingrix vaccine for adults aged 18 and older with known diseases or treatments that increase the risk of shingles, addressing a significant health concern in China with approximately 6 million cases annually [2] - Shanghai Pharmaceuticals received FDA approval for its doxycycline capsules, primarily used for treating inflammatory lesions of rosacea, with projected sales of approximately $130 million in the U.S. for 2024 [3] - Gilead Sciences has completed pre-NDA communication with the NMPA regarding its new drug denifanstat for treating moderate to severe acne, planning to submit the application soon [4] - BD Medical's PleurX IPC system has been approved for clinical use in mainland China under the "Hong Kong and Macau Drug and Device Pass" policy [5] Capital Market Activities - Shanghai Guotou signed agreements with 10 general partners during the 2025 Shanghai International Biopharmaceutical Week, marking a significant step in building a comprehensive fund matrix for the biopharmaceutical industry [6][7] - Jinhai Biological announced plans to issue shares through a simplified procedure, which was approved by its board and supervisory board [8] Industry Events - Guangdong Province's Drug Inspection Institute has launched a new experimental zone for batch release, enhancing the province's capacity for vaccine quality assurance [9] Public Sentiment Alerts - Fosun Pharma announced the withdrawal of its registration application for dimethyl succinate for the treatment of non-small cell lung cancer, stating that this will not significantly impact current performance as they plan to improve the registration materials and resubmit [10]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanguo (Jiangsu) Pharmaceutical Group, has received notification from the National Medical Products Administration regarding the withdrawal of its registration application for Dihydroartemisinin-Ruxolitinib capsules [2] Group 1 - The announcement was made on the evening of October 14 [2] - The withdrawal of the registration application indicates a strategic decision by the company [2]

Core Viewpoint - Fosun Pharma (02196) announced that its subsidiary, Fosun Wanguo (Jiangsu) Pharmaceutical Group Co., Ltd., has received notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for the drug Dihydrosuccinimide Ruxolitinib Capsules (project code: SAF-189) [1] Group 1 - The drug is an innovative small molecule chemical drug primarily intended for the treatment of non-small cell lung cancer (ALK+) and non-small cell lung cancer (ROS1+) [1] - The registration application for this drug for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) positivity was accepted by the NMPA in March 2025 [1] - The withdrawal of the registration application does not signify the termination of the project; Fosun Wanguo will enhance the registration materials according to the latest technical requirements from the NMPA and will resubmit the application as soon as possible [1] Group 2 - The withdrawal of the registration application is not expected to have a significant impact on the current performance of the group (including the company and its subsidiaries) [1]