Core Viewpoint - The Medical Health Index (980016) closed at 6572.66 points, down 0.65%, with a trading volume of 23.397 billion yuan and a turnover rate of 0.87% on November 14 [1] Group 1: Index Performance - Among the index constituents, 16 stocks rose while 33 stocks fell, with Ganli Pharmaceutical leading the gainers at a 2.0% increase and Yirui Technology leading the decliners at a 3.74% decrease [1] - The top ten constituents of the Medical Health Index include major companies such as WuXi AppTec, Hengrui Medicine, and Mindray Medical, with respective weights of 13.66%, 11.00%, and 7.57% [1] Group 2: Market Capitalization and Stock Prices - The total market capitalization of the top ten constituents ranges from 553.09 billion yuan for Kelun Pharmaceutical to 4603.55 billion yuan for Rihai Shenzhou, with stock prices varying from 12.25 yuan to 298.80 yuan [1] - The performance of the top ten stocks shows a mix of slight declines, with WuXi AppTec down 1.49% and Hengrui Medicine down 1.04% [1] Group 3: Capital Flow - The Medical Health Index constituents experienced a net outflow of 472 million yuan from major funds, while retail investors saw a net inflow of 388 million yuan [1] - Detailed capital flow data indicates that Ganli Pharmaceutical had a net inflow of 62.98 million yuan from major funds, despite a net outflow from retail investors [2]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed injectable drug POHERDY®1 (HLX11), indicating a significant advancement in the treatment of HER2-positive metastatic breast cancer [1] Group 1: FDA Approval Details - The FDA approved the biologics license application (BLA) for POHERDY®1, which is an injectable solution for intravenous use [1] - The approved indications include treatment for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 therapy or chemotherapy [1] - The drug is also indicated for use in combination with trastuzumab and chemotherapy for early-stage breast cancer as part of a comprehensive treatment plan [1] Group 2: Treatment Applications - POHERDY®1 is indicated for neoadjuvant treatment in adult patients with HER2-positive locally advanced, inflammatory, or early breast cancer [1] - It is also approved for adjuvant treatment in adult patients with HER2-positive early breast cancer who are at high risk of recurrence [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received FDA approval for its self-developed injection POHERDY®1, indicating a significant advancement in the treatment of HER2-positive metastatic breast cancer [1]. Group 1: FDA Approval Details - The FDA approved the biologics license application (BLA) for POHERDY®1, which is an injection for intravenous use [1]. - The approved indications include treatment for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [1]. - The drug is also approved for use in combination with trastuzumab and chemotherapy for early-stage breast cancer as part of a comprehensive treatment plan [1]. Group 2: Treatment Applications - POHERDY®1 is indicated for neoadjuvant treatment in adult patients with HER2-positive locally advanced, inflammatory, or early breast cancer [1]. - It is also approved for adjuvant treatment in adult patients with HER2-positive early breast cancer who are at high risk of recurrence [1].

Core Viewpoint - The company is progressing as planned in its strategic collaboration with Teva Pharmaceuticals on the development of the drug TEV-56278, which is currently in the preclinical stage within the licensed region [1] Group 1 - The collaboration with Teva Pharmaceuticals is ongoing and on schedule [1] - The drug TEV-56278 is still in the preclinical phase [1] - The company will disclose any significant developments in accordance with the listing rules [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 控股子公司藥品獲美國FDA註冊批准的提示性公告》，僅供參閱。 承董事會命 上海復星醫藥（集團）股份有限公司 董事長 陳玉卿 中國，上海 2025 年1 1 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 ...

证券代码：600196 股票简称：复星医药 编号：临 2025-176 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 注册批准的提示性公告 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。 二、HLX11 的基本信息及上市注册进展情况 HLX11 为本集团（即本公司及控股子公司/单位，下同）自主研发的帕妥珠单抗 生物类似药。 除本次获批外，HLX11于中国及其他国家/地区的注册进展主要包括：（1）2024 年12月，HLX11的上市注册申请获中国国家药品监督管理局受理；（2）2025年3月， HLX11的上市许可申请（MAA）获欧洲药品管理局（EMA）受理；（3）2025年5月，HLX11 的上市注册申请（NDS）获加拿大卫生部（Health Canada）受理。 1 该商品名由 N.V. Organon 于美国注册商标。 1 截至 2025 年 10 月，本集团现阶段针对 HLX11 的累计研发投入约为人民币 2.25 亿元（未经审计）。 根据 IQVIA MIDAS™最新数据 2，2024 年，帕妥珠单 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval for its biologics license application (BLA) for the injection of POHERDY1, a drug indicated for HER2-positive metastatic breast cancer and early-stage breast cancer treatment [1] Group 1: FDA Approval Details - The FDA approved POHERDY1 for use in combination with trastuzumab and docetaxel for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [1] - The drug is also approved as part of a treatment regimen for early breast cancer, specifically for HER2-positive locally advanced, inflammatory, or early breast cancer patients with tumors larger than 2 cm or positive lymph nodes [1] - Additionally, it is indicated for adjuvant treatment in adult patients with HER2-positive early breast cancer at high risk of recurrence [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed injectable drug POHERDY®1, indicating a significant advancement in the treatment of HER2-positive metastatic breast cancer and early-stage breast cancer [1] Group 1: FDA Approval Details - The FDA approved the biologics license application (BLA) for POHERDY®1, which is an injectable solution for intravenous use [1] - The approved indications include treatment for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [1] - The drug is also approved for use in combination with trastuzumab and chemotherapy for early-stage breast cancer patients, specifically for those with locally advanced, inflammatory, or early-stage breast cancer [1] Group 2: Treatment Combinations - POHERDY®1 is indicated for use in conjunction with trastuzumab and docetaxel for treating metastatic breast cancer [1] - It is also part of a comprehensive treatment regimen for early-stage breast cancer patients with high recurrence risk [1] - The drug serves as neoadjuvant therapy for adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer [1]

Core Viewpoint - Southbound funds have increased their holdings in Fosun Pharma (02196.HK), indicating growing investor confidence in the company [1]. Group 1: Shareholding Changes - On November 12, 2025, southbound funds increased their holdings by 97,500 shares, representing a change of 0.03% [2]. - Over the past five trading days, there have been four days of net increases, totaling 2.72 million shares [1][2]. - In the last 20 trading days, there were 13 days of net increases, amounting to 6.41 million shares [1]. Group 2: Current Shareholding Status - As of now, southbound funds hold a total of 314 million shares of Fosun Pharma, which accounts for 56.85% of the company's issued ordinary shares [1][2]. Group 3: Company Overview - Fosun Pharma is primarily engaged in the research, manufacturing, and sales of pharmaceutical products, operating through five segments [2]. - The pharmaceutical segment focuses on innovative drugs, mature pharmaceutical products, and vaccines [2]. - The medical devices and diagnostics segment is involved in the manufacturing and sales of molecular diagnostics, immunodiagnostics, and microbiological diagnostic devices [2]. - The healthcare services segment operates an integrated online and offline medical service platform [2]. - The pharmaceutical distribution and retail segment is responsible for the wholesale and retail of pharmaceutical products [2]. - The company's products are mainly used in the treatment of oncology, immunology, and central nervous system disorders [2].

Core Viewpoint - The Medical Health R Index (480016) closed at 7616.59 points, up 0.5%, with a trading volume of 25.943 billion yuan and a turnover rate of 0.88% on November 12. The index saw 27 stocks rise, led by BeiGene with a 5.62% increase, while 21 stocks fell, with Tigermed leading the decline at 1.68% [1]. Group 1: Index Performance - The Medical Health R Index reported a net inflow of 537 million yuan from main funds, while retail and speculative funds experienced net outflows of 264 million yuan and 273 million yuan, respectively [1]. - The top ten constituent stocks of the index include WuXi AppTec, Hengrui Medicine, and Mindray Medical, with respective weights of 13.66%, 11.00%, and 7.57% [1]. Group 2: Stock Details - BeiGene (688235) had the highest increase at 5.62%, closing at 293.62 yuan with a market capitalization of 452.37 billion yuan [1]. - Hengrui Medicine (600276) saw a 1.70% increase, closing at 62.10 yuan with a market capitalization of 412.17 billion yuan [1]. - WuXi AppTec (603259) experienced a slight decrease of 0.16%, closing at 92.35 yuan with a market capitalization of 275.55 billion yuan [1]. Group 3: Fund Flow Analysis - Hengrui Medicine had a main fund net inflow of 2.74 million yuan, while speculative funds saw a net outflow of 60.98 million yuan [2]. - BeiGene also experienced a main fund net inflow of 1.81 million yuan, with speculative funds facing a net outflow of 172 million yuan [2]. - The overall fund flow indicates a mixed sentiment among investors, with main funds showing some interest while retail and speculative funds are withdrawing [2].