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复星医药(600196) - 复星医药关于控股子公司药品注册申请获受理的公告
2025-12-02 10:15
证券代码:600196 股票简称:复星医药 编号:临 2025-188 关于控股子公司药品注册申请获受理的公告 截至 2025 年 10 月,苏州二叶现阶段针对该药品的累计研发投入约为人民币 861 万元(未经审计)。 根据 IQVIA CHPA 最新数据 1,2024 年,肝素钠注射液于中国境内(不包括港澳 台地区)的销售额约为人民币 13.86 亿元。 1 由 IQVIA 提供,IQVIA 是全球医药健康产业专业信息和战略咨询服务提供商;IQVIA CHPA 数据代表中国境 内 100 张床位以上的医院药品销售市场,不同的药品因其各自销售渠道布局的不同,实际销售情况可能与 IQVIA CHPA 数据存在不同程度的差异。 上海复星医药(集团)股份有限公司 1 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 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 司苏州二叶制药有限公司(以下简称"苏州二叶")就肝素钠注射液(以下简称"该 药品")的药品注册申请获国家药品监督管理局受理。 二、该药品的基本 ...
复星医药(600196) - 复星医药关于控股子公司药品注册申请获受理的公告
2025-12-02 10:15
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 1已获批上市 的所有适应症。 二、HLX14 的基本信息 HLX14 为本集团(即本公司及控股子公司/单位,下同)自主研发的地舒单抗生 物类似药。 截至本公告日期(即 2025 年 12 月 2 日,下同),HLX14 两款产品 2已分别于美 国、欧盟、英国获批上市,于上述相关区域获批适应症覆盖其原研产品(Prolia ®、 XGEVA ®)于当地已获批的所有适应症;此外,2024 年 9 月,HLX14 的上市注册申请 (NDSs)获加拿大卫生部(Health Canada)受理。 截至 2025 年 10 月,本集团现阶段针对 HLX14 的累计研发投入约为人民币 3.20 亿元(未经审计)。 证券代码:600196 股 ...
复星医药(600196) - 复星医药2025年第二次临时股东会决议公告
2025-12-02 10:15
证券代码:600196 证券简称:复星医药 公告编号:临2025-187 上海复星医药(集团)股份有限公司 2025年第二次临时股东会决议公告 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。 本次会议有无否决议案:无 一、会议召开和出席情况 (一)股东会召开的时间:2025 年 12 月 2 日 (二)股东会召开的地点:上海市虹许路 358 号上海天禧嘉福璞缇客酒店 (三)出席会议的普通股股东和恢复表决权的优先股股东及其持有股份情况: | 1、出席会议的股东和代理人人数 | 1,726 | | --- | --- | | 其中:境内上市内资股(A 股)股东人数 | 1,725 | | 境外上市外资股(H 股)股东人数 | 1 | | 2、出席会议的股东所持有表决权的股份总数(股) | 1,081,006,672 | | 其中:境内上市内资股(A 股)股东持有表决权股份总数(股) | 952,051,193 | | 境外上市外资股(H 股)股东持有表决权股份总数(股) | 128,955,479 | | 3、出席会议的股东所持有 ...
复星医药(600196) - 复星医药:国浩律师(上海)事务所关于上海复星医药(集团)股份有限公司2025年第二次临时股东会的法律意见书
2025-12-02 10:15
国浩律师(上海)事务所 法律意见书 国浩律师(上海)事务所 关于上海复星医药(集团)股份有限公司 2025 年第二次临时股东会 的法律意见书 致:上海复星医药(集团)股份有限公司 一、本次股东会的召集、召开程序 就公司召开本次股东会,董事会已于 2025 年 11 月 8 日在《中国证券报》 《上海证券报》《证券时报》和上海证券交易所网站以公告方式通知各股东。公 司另亦按照《香港联合交易所有限公司证券上市规则》的要求,向公司 H 股股东 发出了关于召开本次股东会的通告。 公司发布的上述公告载明了会议的时间、地点、会议审议的事项,说明了股 东有权出席,并可委托代理人出席和行使表决权及有权出席股东的股权登记日, 出席会议股东的登记办法等事项。 国浩律师(上海)事务所(以下简称"本所"),接受上海复星医药(集团) 股份有限公司(以下简称"公司")的委托,指派本所律师出席公司 2025 年第二 次临时股东会(以下简称"本次股东会"),并根据《中华人民共和国公司法》 (以下简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证券法》")、 《上市公司股东会规则》(以下简称"《股东会规则》")以及《上海复星医药( ...
复星医药(600196.SH):肝素钠注射液药品注册申请获受理
Ge Long Hui A P P· 2025-12-02 10:12
Core Viewpoint - Fosun Pharma's subsidiary, Suzhou Er Ye Pharmaceutical, has received acceptance for the drug registration application of sodium heparin injection by the National Medical Products Administration, indicating progress in the company's drug development pipeline [1]. Group 1: Drug Information - The sodium heparin injection is a self-developed chemical drug by the group [1]. - The drug is intended for multiple uses, including the prevention and treatment of venous thrombosis and pulmonary embolism, as well as for patients at risk of thromboembolic diseases due to major surgeries [1]. - Additional applications include treatment for atrial fibrillation with embolism, acute and chronic consumptive coagulopathy, and as an anticoagulant in various medical procedures such as blood transfusions and dialysis [1].
复星医药(600196) - 复星医药H股公告-证券变动月报表
2025-12-02 09:30
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12月2日 FF301 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11月30日 狀態: 新提交 致:香港交易及結算所有限公司 I. 法定/註冊股本變動 | 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 | R ...
复星医药(02196) - 截至2025年11月30日之股份发行人的证券变动月报表
2025-12-02 08:31
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12月2日 I. 法定/註冊股本變動 | 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 | 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: ...
复星医药:创新药的“未来三重奏”
Core Insights - Fosun Pharma has successfully treated over 84 million severe malaria patients in Africa with its artemisinin-based products, showcasing its commitment to addressing unmet clinical needs [1] - The company has established a clear strategic focus for the 14th Five-Year Plan, emphasizing innovation, deep internationalization, and embracing AI as key pillars for high-quality development [1][7] - Fosun Pharma has achieved significant milestones in innovation, including the launch of 12 self-developed and licensed innovative drugs during the 14th Five-Year Plan [1][4] Innovation and Product Development - Fosun Pharma has developed several firsts in the industry, including China's first self-developed biosimilar drug Hanlikang and the first CAR-T cell therapy product Yikaida [2][3] - The company has built a comprehensive innovation system with four core technology platforms: small molecules, antibodies, ADCs, and cell therapy, enabling full-cycle innovation from R&D to commercialization [3] Financial Performance - In the first three quarters of 2025, Fosun Pharma's innovative drug revenue exceeded 6.7 billion yuan, reflecting an 18.09% year-on-year growth [4] - The company aims to continue optimizing its innovation pipeline value over the next five years, focusing on unmet clinical needs [4] Global Expansion Strategy - Fosun Pharma has actively expanded its global market presence, with its anti-tumor innovative drug approved in approximately 40 countries and regions during the 14th Five-Year Plan [5][6] - The company has established a marketing team of over 1,000 people and a network covering more than 110 countries, emphasizing localized strategies for different markets [6] Embracing AI in Development - Fosun Pharma is committed to integrating AI into its operations, viewing it as a tool for enhancing R&D efficiency and organizational evolution [7][8] - The company has launched its internally developed PharmAID decision-making platform, which is already being utilized in various stages of drug development [7][8]
上海复星医药(集团)股份有限公司 关于控股子公司药品获临床试验批准的公告
Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received approval from the National Medical Products Administration for clinical trials of HLX37 injection, a bispecific antibody for treating advanced/metastatic solid tumors [2][3]. Group 1 - HLX37 is a recombinant humanized bispecific antibody targeting PD-L1 and VEGF, developed for the treatment of advanced/metastatic solid tumors. Preclinical studies indicate that HLX37 can inhibit tumor growth and has good safety profiles [3]. - As of October 2025, the cumulative R&D investment in HLX37 by the group is approximately RMB 50.23 million (unaudited) [3]. - According to IQVIA MIDASTM data, the global sales of PD-1/PD-L1 and VEGF bispecific antibody products are projected to be around USD 920 million in 2024, with the first product expected to be approved in May 2024 [3].
“药”创新 “药”转型 “药”出海——上海生物医药行业面向“十五五”谋新篇布新局
Core Viewpoint - Shanghai is emerging as a global hub for biopharmaceutical innovation, with local companies leveraging innovation, transformation, and internationalization to enhance their competitiveness on the world stage [4][6]. Group 1: Innovation - Junshi Bioscience has focused on unmet clinical needs, successfully launching its PD-1 monoclonal antibody, which has reshaped the landscape for domestic innovative drugs in international markets [4][5]. - Fosun Pharma has achieved significant milestones in innovation, including the development of China's first self-developed CAR-T cell therapy product and the first PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer [8][9]. - The company has established a comprehensive innovation system, with over 12 innovative drugs launched during the 14th Five-Year Plan period, focusing on oncology, immune inflammation, and chronic diseases [11][12]. Group 2: Transformation - First Pharmaceutical has adapted to the challenges posed by e-commerce in the pharmaceutical retail sector by integrating smart healthcare services, revitalizing its traditional pharmacy model [5][30]. - Fosun Pharma's transformation journey aligns with the rapid evolution of China's innovative drug industry, emphasizing a combination of generics and original innovations [5][11]. - Seer Bio has expanded its research into broader biotoxin treatments after mastering snake venom therapies, indicating a strategic shift towards a wider range of biological toxin therapies [5][26]. Group 3: Internationalization - Fosun Pharma has successfully penetrated international markets, with its anti-tumor innovative drug, Slulizumab, approved in approximately 40 countries, showcasing the company's global strategy [12][13]. - Junshi Bioscience has transitioned from a "single-point breakthrough" to "platform innovation," with its core product, Toripalimab, now available in major markets including the US and EU [16][17]. - The company is building a global commercialization network through partnerships and local teams, aiming to enhance its international presence [22][23]. Group 4: Market Challenges and Opportunities - First Pharmaceutical faces significant challenges in the pharmaceutical distribution industry, including regulatory changes, evolving sales models, and increased consumer expectations for professional services [32][33]. - Despite these challenges, First Pharmaceutical has reported substantial revenue growth, with sales increasing from 1.398 billion yuan in 2021 to 1.915 billion yuan in 2024 [32]. - The company is strategically focusing on the silver economy, aiming to develop integrated services for the elderly, aligning with national policies on aging [34][35].