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） 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。 （股份代號：02196） 海外監管公告 证券代码：600196 股票简称：复星医药 编号：临 2025-149 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 控股子公司藥品獲歐盟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9 月1 9 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 ...

Group 1: Changshan Pharmaceutical - The company is preparing for clinical trials of Aibennate peptide for weight loss, with no current plans for oral formulation development [1] - Aibennate peptide is a long-acting GLP-1 receptor agonist, developed through chemical modification of exenatide [1] - The marketing preparation includes team building, product knowledge training, and marketing strategy formulation [1] Group 2: Fosun Pharma - Four innovative drugs approved in the first half of the year are expected to gradually increase sales in the coming months [2] - Innovative drug revenue exceeded 4.3 billion yuan, a year-on-year increase of 14.26%, accounting for over 30% of total drug revenue [2] - The company is actively participating in negotiations for the inclusion of its innovative drugs in insurance and national basic medical insurance directories [2] Group 3: Tiantan Biological Products - The company has established an international cooperation department to enhance its global market presence [3] - Products such as tetanus immunoglobulin and rabies immunoglobulin have already been exported [3] - The company is focused on international certification and registration of key products [3] Group 4: Kangtuo Medical - The US-based subsidiary BIOPLATE has launched a local production line for PEEK plates [4] - The company has completed market access in nearly 40 countries and regions [4] - The marketing of "4D bioactive plates" and PEEK fixation systems is underway in the US [4] Group 5: Tailong Pharmaceutical - The company is focusing on the development of modified new drugs across various therapeutic areas including respiratory, digestive, and oncology [5] - Projects in progress include treatments for Alzheimer's disease and schizophrenia [5] Group 6: Heng Rui Pharmaceutical - The HRS-5635 injection has been included in the list of proposed breakthrough therapies [6][7] - Chronic hepatitis B infection affects approximately 257 million people globally, with a significant mortality rate [7] - There is a pressing need for more effective treatments to achieve functional cure for chronic hepatitis B [7]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products are both injections of dezhushe monoclonal antibody, with specifications of 60mg/mL for BILDYOS® and 120mg/1.7mL for BILPREVDA® [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway, which are part of the European Economic Area [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are biosimilars of denosumab, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway [1] - HLX14, the project code for these biosimilars, is developed independently by the group [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1: Company Developments - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are biosimilars of denosumab, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] - The marketing authorization allows for the sale of these products across all EU member states, as well as in Iceland, Liechtenstein, and Norway [1] Group 2: Industry Implications - The approval of HLX14 represents a significant advancement in the biosimilar market, particularly for osteoporosis treatments, which is a growing area of need in the healthcare sector [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（以下简称"复宏汉霖"）及其控股子公司 自主研发的 BILDYOS ®（规格 60 mg/mL）、BILPREVDA ®（120 mg/1.7mL）两个地舒单 抗注射液产品（项目代号：HLX14）的上市许可申请（MAAs）获欧盟委员会（即 European Commission）批准（以下简称"本次获批"）。据此，BILDYOS ®及 BILPREVDA ®于所 有欧盟成员国及冰岛、列支敦士登和挪威（分别为欧洲经济区国家）获得集中 上市许可。 本次获批适应症为参照药 Prolia ®与 XGEVA ®于欧盟上市的所有适应症，具体情 况如下： 证券代码：600196 股票简称：复星医药 编号：临 2025-149 上海复星医药（集团）股份有限公司 关于控股子公司药品获欧盟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。 一、概况 | 1 欧洲商品名 | 获批适应症 | | --- | --- | | 产品一 ...

Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the European Commission for the marketing authorization applications (MAAs) of two products, BILDYOS® and BILPREVDA® [1] - BILDYOS® (60mg/mL) and BILPREVDA® (120mg/1.7mL) are both injection products containing dexsilone, which are now approved for sale in all EU member states as well as Iceland, Liechtenstein, and Norway [1]

Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, received EU approval for its self-developed injection products BILDYOS and BILPREVDA, targeting osteoporosis and related conditions [1] Group 1: Product Approval - The European Commission approved the marketing authorization for BILDYOS (60mg/mL) and BILPREVDA (120mg/1.7mL) [1] - These products are indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for prostate cancer-related bone loss and other severe bone conditions [1] Group 2: Financial Investment and Projections - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million [1] - The projected global sales for the injection products in 2024 are estimated to be around USD 7.463 billion [1]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received approval from the European Commission for the marketing authorization applications (MAAs) of two monoclonal antibody injection products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are based on the project code HLX14 [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway, which are part of the European Economic Area [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fuhong Hanlin, has received EU approval for two denosumab injection products, BILDYOS® and BILPREVDA®, targeting osteoporosis treatment in high-risk postmenopausal women and men [1] Group 1 - The approved products are indicated for the treatment of osteoporosis in high-risk populations [1] - HLX14 has also been approved in the US for specific osteoporosis indications and its registration application in Canada has been accepted [1] - The commercialization rights for HLX14 have been granted to Organon LLC, with Fosun Pharma set to enjoy related rights under the licensing agreement [1]