每经AI快讯，12月3日，复星医药（600196）(600196.SH)公告称，控股子公司上海复星医药产业发展有 限公司(简称"复星医药产业")收到国家药品监督管理局关于同意FXS887片(简称"FXS0887")用于晚期恶 性实体瘤开展临床试验的批准。FXS0887为本集团(即本公司及控股子公司/单位)自主研发的口服小分子 创新药物，拟用于治疗晚期恶性实体瘤。截至本公告日期(即2025年12月3日)，于全球范围内尚无同靶 点的小分子抑制剂单药或联合治疗方案获批上市。 ...

Core Viewpoint - Fosun Pharma's subsidiary has received approval from the National Medical Products Administration for clinical trials of FXS887 for advanced malignant solid tumors, indicating a significant step in the company's oncology pipeline [1] Group 1: Clinical Development - The company plans to conduct Phase I clinical trials for FXS887 in China once conditions are met [1] - As of October 2025, the cumulative R&D investment for FXS887 is approximately RMB 44 million [1] - No other small molecule inhibitors targeting the same pathway have been approved globally for monotherapy or combination therapy [1]

Core Insights - The biopharmaceutical sector is one of the fastest-growing areas in the pharmaceutical industry, driven by an aging population and increased public health awareness [1][5] - China's biopharmaceutical market is projected to grow from CNY 312 billion in 2019 to CNY 587.1 billion in 2024, and is expected to reach CNY 675.2 billion by 2025, with a potential to hit CNY 1.149 trillion in the next five years [1][5][6] - Innovation remains the core driver of growth in the biopharmaceutical industry, which is capital-intensive and requires significant R&D investment [1][6] Industry Definition and Classification - Biopharmaceuticals are medical products manufactured using biological methods, aimed at replicating the activity of natural substances [2][4] - They can be categorized into vaccines, blood products, biopharmaceutical drugs, diagnostic reagents, and others, with further subdivisions based on source or mechanism of action [2] Current Industry Status - The global biopharmaceutical market is expected to grow from USD 286.4 billion in 2019 to USD 461.6 billion in 2024, with the original biopharmaceutical market projected to increase from USD 268.9 billion to USD 427.9 billion in the same period [5] - China plays a significant role in the global biopharmaceutical market, with rapid growth driven by favorable policies, increased R&D investment, and advancements in biotechnology [5][6] Industry Development Environment - Policies - The Chinese government has implemented various laws and policies to encourage biopharmaceutical R&D, including the Drug Registration Management Measures and regulations for clinical research and application of biomedical technologies [7] Competitive Landscape - The biopharmaceutical sector is recognized as a "new frontier" in the pharmaceutical industry, with major global players actively entering the market [9] - Key companies in China's biopharmaceutical industry include WuXi AppTec, Hengrui Medicine, ZhiFei Biological, BeiGene, and others, with a competitive landscape characterized by differentiated strategies [9] Future Development Trends - Market demand for biopharmaceuticals is expected to continue growing, supported by policy backing, technological advancements, and increased health awareness [10] - Domestic companies are transitioning from biosimilars to First-in-Class drugs, with examples like Hengrui Medicine's ADC drug showing superior efficacy [10][11] - Personalized medicine based on genetic testing is anticipated to become a trend, with increasing international recognition of Chinese innovative drugs [11]

Group 1 - The company held its second extraordinary general meeting of shareholders in 2025, with no resolutions being rejected [2][3] - The meeting was conducted in compliance with the Company Law and the company's articles of association, with a total of 2,639,554,073 shares eligible for voting [2][3] - The meeting was attended by 8 out of 11 directors, including the chairman and CEO, while 3 directors were absent due to other commitments [3] Group 2 - The company announced that its subsidiary, Suzhou Er Ye Pharmaceutical Co., Ltd., received acceptance for its drug registration application for Heparin Sodium Injection from the National Medical Products Administration [8] - The drug is intended for various medical uses, including the prevention and treatment of venous thromboembolism and anticoagulation during surgeries [9][10] - As of October 2025, the cumulative R&D investment for this drug was approximately RMB 8.61 million, with projected sales in China for 2024 estimated at RMB 1.386 billion [10] Group 3 - The company’s subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received acceptance for its drug registration application for HLX14, a biosimilar of Denosumab [13] - HLX14 has been approved in the US and EU, with a cumulative R&D investment of approximately RMB 320 million as of the announcement date [15] - Global sales for Denosumab products are projected to be around USD 7.463 billion in 2024 [16] Group 4 - The company is involved in a private equity investment fund, the Dalian Star Future Fund, which focuses on investing in early-stage medical technology companies [20] - A recent agreement was made for a transfer of partnership shares within the fund, maintaining the company's shareholding percentage at 51% [21][23] - The new partner, Dalian Jinyun, has no prior relationship with the company and does not hold any shares in it [24]

Core Points - The subsidiary of Fosun Pharma, Fuhong Hanlin, has received acceptance for the drug registration application of the biosimilar HLX14, a drug similar to Dexamethasone, by the National Medical Products Administration [1] - The application is classified as a Class 3.3 therapeutic biological product, with indications based on all approved indications of the reference drug Prolia in China [1] Product Information - HLX14 has been approved for marketing in the United States, European Union, and the United Kingdom, covering all indications of the original product [1] - The application for marketing registration was accepted by Health Canada in September 2024 [1] - Cumulative R&D investment is approximately 320 million yuan (unaudited) as of October 2025 [1] Market Outlook - According to IQVIA data, the global sales of Dexamethasone products are projected to be approximately 7.463 billion USD in 2024 [1]

Core Viewpoint - Fosun Pharma's subsidiary, Suzhou Er Ye Pharmaceutical, has received acceptance for the drug registration application of sodium heparin injection from the National Medical Products Administration of China, indicating progress in the commercialization of this self-developed chemical drug [1] Company Summary - The sodium heparin injection is intended for multiple medical uses, including the prevention and treatment of venous thrombosis and pulmonary embolism, as well as anticoagulation during surgeries and dialysis [1] - As of October 2025, the cumulative R&D investment for this drug by Suzhou Er Ye is approximately RMB 8.61 million (unaudited) [1] Market Summary - According to the latest IQVIA CHPA data, the sales revenue of sodium heparin injection in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 1.386 billion in 2024 [1] - The drug must obtain regulatory approval before commercial production can commence, but the acceptance of the application will not have a significant impact on the current performance of the group [1]

Core Viewpoint - Fosun Pharma's subsidiary, Suzhou Er Ye Pharmaceutical, has received acceptance for the drug registration application of sodium heparin injection from the National Medical Products Administration, indicating a significant step in the company's product development pipeline [1] Group 1: Product Development - The sodium heparin injection is a self-developed chemical drug by the group, intended for multiple medical uses including prevention and treatment of venous thrombosis and pulmonary embolism, and as an anticoagulant in various surgical and medical procedures [1] - As of October 2025, the cumulative R&D investment for this drug by Suzhou Er Ye is approximately RMB 8.61 million (unaudited) [1] Group 2: Market Potential - According to IQVIA CHPA data, the sales revenue of sodium heparin injection in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 1.386 billion in 2024 [1]

Core Viewpoint - Fosun Pharma's subsidiary, Suzhou Er Ye Pharmaceutical, has received acceptance for its drug registration application for Heparin Sodium Injection from the National Medical Products Administration of China, indicating progress in the commercialization of this self-developed chemical drug [1] Company Summary - The Heparin Sodium Injection is intended for multiple medical uses, including the prevention and treatment of venous thrombosis, pulmonary embolism, and anticoagulation during surgeries and dialysis [1] - As of October 2025, the cumulative R&D investment for this drug by Suzhou Er Ye is approximately RMB 8.61 million (unaudited) [1] - The projected sales revenue for Heparin Sodium Injection in mainland China (excluding Hong Kong, Macau, and Taiwan) is estimated to be around RMB 1.386 billion in 2024 according to IQVIA CHPA data [1] - The acceptance of the drug registration application is not expected to have a significant impact on the company's current performance [1]

格隆汇12月2日丨复星医药(02196.HK)近日，上海复星医药(集团)股份有限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自主研发的地舒单抗生物类似药HLX14(即重组抗RANKL全人 单克隆抗体注射液，申请注册分类：治疗用生物制品3.3类；以下简称"HLX14")的药品注册申请获国家 药品监督管理局受理。本次申报适应症为其参照药普罗力®(英文商品名：Prolia®)于中国境内已获批上 市的所有适应症。 ...

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 （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獲受理的公告》，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 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） 陳玉卿 中國，上海 2025 年1 2 月2 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、王可心先生及劉毅先生；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；以及本公司職工董事為嚴佳女士。 * ...