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]

Core Points - Fosun Pharma's subsidiary, Fosun Wanguo, has received notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for the drug Dihydrosuccinimide Capsules [1] - The drug is an innovative small molecule chemical drug intended primarily for the treatment of non-small cell lung cancer (ALK+ and ROS1+) [1] - The registration application for the drug was accepted in March for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who are ALK positive [1] - The withdrawal of the registration application does not signify the termination of the project; Fosun Wanguo plans to improve the registration materials according to the latest technical requirements from the NMPA and will resubmit the application [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanguo, has received notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for the drug SAF-189, an innovative small molecule chemical drug intended for treating non-small cell lung cancer (NSCLC) [1] Group 1 - The drug SAF-189 was primarily aimed at treating ALK+ and ROS1+ non-small cell lung cancer [1] - The registration application for SAF-189 was accepted by the NMPA in March 2025 for treating locally advanced or metastatic NSCLC patients with ALK positivity [1] - The withdrawal of the registration application does not signify the termination of the project; Fosun Wanguo plans to enhance the registration materials according to the latest technical requirements from the NMPA and will resubmit the application promptly [1] Group 2 - The withdrawal of the registration application is not expected to have a significant impact on the current performance of the group, which includes the company and its subsidiaries [1]

Core Insights - Fosun Pharma's subsidiary, Fosun Wanguo, has received notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for the drug SAF-189, an innovative small molecule chemical drug intended for treating non-small cell lung cancer (NSCLC) [1] Group 1 - The drug SAF-189 was initially accepted for registration in March 2025 for treating ALK-positive locally advanced or metastatic NSCLC patients [1] - The withdrawal of the registration application is not a termination of the project; Fosun Wanguo plans to improve the registration materials according to the latest technical requirements from the NMPA and will resubmit the application as soon as possible [1] - The withdrawal of the registration application is not expected to have a significant impact on the current performance of the group, which includes the company and its subsidiaries [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，並明確表示，概不對因本公告全部或任何部份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。 董事會會議日期 上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司（「 本 公 司 」）董 事 會（「 董 事 會 」）茲 通 告 謹 定 於 2025 年 10月28日（ 星期二 ）舉行董事會會議，藉以（ 其中包括 ）考慮及通過本公司及其附屬公司截至 2025年9月30日止九個月的第三季度業績並予以刊發。 上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. * （ 於中華人民共和國註冊成立的股份有限公司） （股份代號：02196） 中國，上海 2025年10月14日 於本公告日期，本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生及王可心先生；本公司之非執行 董事為陳啟宇先生及潘東輝先生；本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生 及楊玉成先生；以及本公司 ...

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanguo, has withdrawn the registration application for the innovative drug SAF-189 (Dibutyl Succinate Reversitin Capsules) intended for treating non-small cell lung cancer (ALK+ and ROS1+) [1] Group 1: Company Actions - Fosun Wanguo received a notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for SAF-189 [1] - The withdrawal is not a termination of the project; Fosun Wanguo plans to improve the registration materials according to the latest technical requirements from the NMPA and will resubmit the application as soon as possible [1] - The withdrawal of the registration application will not have a significant impact on the current performance of the group, which includes the company and its subsidiaries [1] Group 2: Drug Information - SAF-189 is an innovative small molecule chemical drug primarily aimed at treating ALK-positive and ROS1-positive non-small cell lung cancer [1] - The drug's registration application for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with ALK positivity was accepted by the NMPA in March 2025 [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，並明確表示，概不對因本公告全部或任何部份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。 上 海 復 星 醫 藥（ 集 團 ）股 份 有 限 公 司 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* （於中華人民共和國註冊成立的股份有限公司） （股份代號：02196） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出。 茲載列上海復星醫藥（集團）股份有限公司（「本公司」）在上海證券交易所網站刊登的《關於 控股子公司藥品註冊申請進展的公告》，僅供參閱。 承董事會命 陳玉卿 中國，上海 2025 年1 0 月1 4 日 於本公告日期，本公司之執行董事為陳玉卿先生、關曉暉女士、文德鏞先生及王可心先生；本公司之非執行 董事為陳啟宇先生及潘東輝先生；本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生 及楊玉成先生；以及本公司之職工董事為嚴佳女士。 * 僅供識別 证券代码：600196 股票简称： ...

证券代码：600196 股票简称：复星医药 编号：临 2025-157 上海复星医药（集团）股份有限公司 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。2025 年 3 月，该新药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）患者治疗的药品注册申请获国家药监局受 理。 本次撤回注册申请并非终止该项目。复星万邦将根据国家药监局最新技术要求， 进一步完善注册资料，并尽快重新提交药品注册申请。本次撤回注册申请不会对本 集团（即本公司及控股子公司）当期业绩产生重大影响。 关于控股子公司药品注册申请进展的公告 董事会 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。 二零二五年十月十四日 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（以下简称"复星万邦"）收到国家药品监 督管理局（以下简称"国家药监局"）关于同意其撤回丁二酸复瑞替尼胶囊（项目 代号：SAF-189；以下简称"该新药"）注册申 ...

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanguo, has received notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for the drug Dihydrosuccinimide Ruxolitinib capsules, which is intended for the treatment of non-small cell lung cancer (ALK+ and ROS1+) [1] Group 1 - The new drug is an innovative small molecule chemical drug primarily aimed at treating non-small cell lung cancer [1] - The registration application for the drug was accepted by the NMPA in March 2025 for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who are positive for anaplastic lymphoma kinase (ALK) [1] - The withdrawal of the registration application does not signify the termination of the project; Fosun Wanguo plans to enhance the registration materials according to the latest technical requirements from the NMPA and will resubmit the application as soon as possible [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanguo, has received notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for the drug Dihydrosuccinimide Ruxolitinib Capsules, which is intended for the treatment of non-small cell lung cancer (ALK+ and ROS1+) [1] Summary by Categories Company Actions - The withdrawal of the registration application will not have a significant impact on the company's current performance [1] - Fosun Wanguo plans to improve the registration materials according to the latest technical requirements from the NMPA and will resubmit the drug registration application as soon as possible [1] Industry Context - The drug in question is an innovative small molecule chemical drug aimed at treating specific types of non-small cell lung cancer, indicating ongoing developments in targeted cancer therapies within the pharmaceutical industry [1]