Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1: Product Approval and Specifications - HLX14 is a biosimilar of denosumab, with two specifications: 60mg/mL and 120mg/1.7mL [1] - The FDA approval allows HLX14 to be used for treating osteoporosis in postmenopausal women and other indications consistent with the reference drug's label [1] Group 2: Regulatory Progress in Other Regions - In May 2024, HLX14's marketing authorization application (MAA) will be accepted by the European Medicines Agency (EMA), with a positive review opinion expected by July 2025 [1] - In September 2024, HLX14's new drug submission (NDS) will be accepted by Health Canada [1]

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"） 自主研发的 60 mg/mL、120 mg/1.7mL 两项规格的地舒单抗注射液（项目代号：HLX14） 的生物制品许可申请（BLA）获美国 FDA（即美国食品药品监督管理局）批准，本次 获批情况如下： 证券代码：600196 股票简称：复星医药 编号：临 2025-143 上海复星医药（集团）股份有限公司 关于控股子公司获美国 FDA 药品注册批准的公告 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 | 美国商品名 | 获批适应症 | | --- | --- | | | （1）骨折高风险的绝经后妇女的骨质疏松症治疗； （2）骨折高风险的男性骨质疏松患者的增加骨量治疗； | | | （3）糖皮质激素引起的骨折高风险的男性与女性骨质疏松症的 | | 产品一：BILDYOS®1 | 治疗； | | （60 mg/mL） | （4）接受雄激素剥夺治疗的骨折高风险的非转移性前列腺癌 ...

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 控股子公司獲美國FDA藥品註冊批准的公告》，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9 月1 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、潘東輝先生及吳以芳先生；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 ...

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, received FDA approval for its self-developed denosumab injection (HLX14) in two specifications, which includes five indications for osteoporosis treatment [1] Group 1: Product Approval - The FDA approved the biologics license application (BLA) for denosumab injection in two concentrations: 60mg/mL and 120mg/1.7mL [1] - The approved indications include treatment for osteoporosis in postmenopausal women, osteoporosis in male patients, glucocorticoid-induced osteoporosis, non-metastatic prostate cancer in male patients undergoing androgen deprivation therapy, and breast cancer in women receiving aromatase inhibitor therapy [1] Group 2: Market Potential - The global sales revenue for denosumab injection is approximately $7.462 billion [1]

FF301 致：香港交易及結算所有限公司 公司名稱: 上海復星醫藥(集團)股份有限公司 ( 於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02196 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 551,940,500 | RMB | | 1 RMB | | 551,940,500 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 551,940,500 | RMB | | 1 RMB | | 551,940,500 | ...

Core Insights - The core viewpoint emphasizes that Fosun International is effectively mitigating market uncertainties through its global operational capabilities, while also experiencing signs of economic recovery in China [1] Financial Performance - In the first half of the year, Fosun reported total revenue of 87.28 billion yuan, operating profit of 3.15 billion yuan, and net profit attributable to shareholders of 660 million yuan [1] - Fosun Pharma's net profit increased by 37.6% year-on-year, and Fosun Tourism's revenue reached a historical high [1] Strategic Focus - Fosun is shifting from blind expansion to a strategy of "slimming down and strengthening," focusing on core businesses and long-term value creation [1][2] - The company has been divesting non-core assets, including the sale of German private bank HAL for 670 million euros and the complete exit from Homelike [2] Operational Strategy - Fosun has developed a "red-yellow-green light" mechanism to evaluate assets based on their alignment with core family consumption sectors, profitability, and sustainability [3] - The company aims for a "double hundred billion" target, seeking to achieve 10 billion yuan in operating profit and self-owned cash flow, with 7 billion yuan expected from four core subsidiaries [3] Asset Management - The strategy of "embracing light and combining heavy" focuses on enhancing cooperation with various capital sources to improve light asset operations [4] - The Taicang Alps International Resort project is highlighted as a significant example of this light asset capability [4][5] Tourism Sector - Fosun Tourism is concentrating on vacation strategies, leveraging the Club Med brand to cater to the evolving preferences of Chinese consumers for "light vacations" [6] - The company is exiting unrelated businesses, such as scenic area construction and management services, to focus solely on vacation-related operations [6] AI Integration - Fosun is committed to an "All in AI" approach, emphasizing the importance of AI applications in enhancing business processes rather than merely investing in AI technology [8] - The company is currently in the "business + AI" phase, aiming to transition to "AI + business" to fundamentally restructure its core business processes [8][9] Pharmaceutical Innovation - Fosun Pharma recognizes the potential of AI in drug development, launching the PharmAID platform to provide quantifiable decision-making support in research and clinical trials [9]

Group 1 - The CRO concept index increased by 2.88%, ranking 8th among concept sectors, with 56 stocks rising, including Baohua Pharmaceutical, Dezhan Health, and ST Weiming hitting the daily limit [1][2] - Notable gainers in the CRO sector included Yiqiao Shenzhou, Puris, and Baicheng Pharmaceutical, which rose by 10.65%, 8.59%, and 8.46% respectively [1][2] - The sector saw a net inflow of 1.876 billion yuan, with 39 stocks receiving net inflows, and 7 stocks attracting over 50 million yuan [2][3] Group 2 - The leading stock in terms of net inflow was WuXi AppTec, with a net inflow of 1.04 billion yuan, followed by Fosun Pharma, Dezhan Health, and Chengdu Xian Dao with net inflows of 233 million yuan, 126 million yuan, and 93.8 million yuan respectively [2][3] - The highest net inflow ratios were observed in Dezhan Health, ST Weiming, and Baohua Pharmaceutical, with ratios of 26.23%, 17.45%, and 16.34% respectively [3][4] - The trading volume and turnover rates for key stocks in the CRO sector showed significant activity, with WuXi AppTec having a turnover rate of 4.09% and a price increase of 8.02% [3][4]

Group 1 - The CRO concept sector increased by 2.88%, ranking 8th among concept sectors, with 56 stocks rising, including Baohua Pharmaceutical, Dezhan Health, and ST Unimed hitting the daily limit [1] - Notable gainers in the CRO sector included Yiqiao Shenzhou, Puris, and Baicheng Pharmaceutical, which rose by 10.65%, 8.59%, and 8.46% respectively [1] - The sector saw a net inflow of 1.876 billion yuan, with 39 stocks receiving net inflows, and 7 stocks exceeding 50 million yuan in net inflow, led by WuXi AppTec with 1.04 billion yuan [2][3] Group 2 - The top stocks by net inflow ratio included Dezhan Health, ST Unimed, and Baohua Pharmaceutical, with net inflow ratios of 26.23%, 17.45%, and 16.34% respectively [3] - The top stocks in the CRO concept by net inflow included WuXi AppTec, Fosun Pharma, and Dezhan Health, with net inflows of 1.04 billion yuan, 233.4 million yuan, and 126.1 million yuan respectively [3][4] - Stocks with significant declines included Sichuan Shuangma, ST Biology, and Hitec Biotech, which fell by 3.73%, 3.03%, and 2.67% respectively [1][6]

Core Viewpoint - The weight loss drug sector has shown a significant increase, with a rise of 2.99% as of September 1, ranking it seventh among concept sectors, driven by strong performances from several stocks [1][2]. Group 1: Sector Performance - The weight loss drug sector saw 48 stocks increase in value, with notable gainers including Baihua Pharmaceutical (up 10.91%), Dezhan Health (up 10.00%), and Health元 (up 9.98%) [1][2]. - Conversely, stocks such as Sichuan Shuangma, Nawei Technology, and Deyuan Pharmaceutical experienced declines, with drops of 3.73%, 3.61%, and 1.64% respectively [1][2]. Group 2: Capital Flow - The weight loss drug sector attracted a net inflow of 1.528 billion yuan, with 35 stocks receiving net inflows, and 6 stocks exceeding 100 million yuan in net inflows [2][3]. - Leading the net inflow was Heng Rui Pharmaceutical, which saw a net inflow of 524 million yuan, followed by Fosun Pharmaceutical (233 million yuan), Health元 (213 million yuan), and Yi Pin Hong (128 million yuan) [2][3]. Group 3: Stock Specifics - Health元, Dezhan Health, and Baihua Pharmaceutical had the highest net inflow ratios at 28.67%, 26.23%, and 16.34% respectively [3]. - Specific stock performances included Heng Rui Pharmaceutical (up 3.20% with a turnover rate of 1.37%), Fosun Pharmaceutical (up 6.38% with a turnover rate of 4.71%), and Health元 (up 9.98% with a turnover rate of 3.05%) [3][4].

Group 1 - The chemical pharmaceutical sector increased by 3.54% on September 1, with Maiwei Biotech leading the gains [1] - The Shanghai Composite Index closed at 3875.53, up 0.46%, while the Shenzhen Component Index closed at 12828.95, up 1.05% [1] - Notable gainers in the chemical pharmaceutical sector included Maiwei Biotech, which rose by 20.00% to a closing price of 57.60, and Xingqi Eye Medicine, which increased by 14.65% to 77.54 [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 1.245 billion yuan from main funds, while retail funds experienced a net outflow of 41.1167 million yuan [2] - The top stocks by main fund inflow included Heng Rui Medicine with 474 million yuan and Fuxing Medicine with 256 million yuan [3] - Conversely, stocks like Duorui Medicine and ST Suwu experienced significant declines, with Duorui Medicine down 9.36% to 41.17 [2][3]