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]

Core Insights - Guangzhou Legu Jianjia Rehabilitation Hospital Co., Ltd. has been established with a registered capital of 80 million yuan [1] - The company is involved in various services including the sale of Class I medical devices, health consulting services (excluding diagnostic services), remote health management services, elderly care services, and hospital management [1] - The company is jointly owned by Guangzhou Legu Medical Investment Co., Ltd. and Shanghai Fosun Pingyao Investment Management Co., Ltd., a wholly-owned subsidiary of Fosun Pharma [1] Company Information - Legal representative: Zheng Chunjian [1] - Registered capital: 80 million yuan [1] - Business scope includes: - Sale of Class I medical devices - Health consulting services (excluding diagnostic services) - Remote health management services - Elderly care services - Hospital management [1] Shareholding Structure - Guangzhou Legu Medical Investment Co., Ltd. holds 60.01% of the shares, contributing 48 million yuan [2] - Shanghai Fosun Pingyao Investment Management Co., Ltd. holds 20% of the shares, contributing 16 million yuan [2] - Guangzhou Taibo Rehabilitation Hospital Management Co., Ltd. holds 20% of the shares, contributing 16 million yuan [2]

Group 1 - The core viewpoint of the news highlights the recent stock performance and financial metrics of Fosun Pharma, indicating a decline in stock price and significant net outflow of funds [1][2] - As of September 19, Fosun Pharma's stock price decreased by 2.02% to 30.97 CNY per share, with a total market capitalization of 82.703 billion CNY [1] - The company has seen a year-to-date stock price increase of 26.24%, but a recent decline of 1.74% over the last five trading days [1] Group 2 - Fosun Pharma's main business segments include drug manufacturing and research, with a revenue composition of 45.68% from anti-tumor and immune regulation products, 17.53% from anti-infection products, and 13.83% from metabolic and digestive system products [1] - For the first half of 2025, Fosun Pharma reported a revenue of 19.514 billion CNY, a year-on-year decrease of 4.63%, while the net profit attributable to shareholders increased by 38.96% to 1.702 billion CNY [2] - The company has distributed a total of 12.593 billion CNY in dividends since its A-share listing, with 2.691 billion CNY distributed in the last three years [3]

Group 1 - The core point of the article highlights that southbound funds increased their holdings in Fosun Pharma (02196.HK) by 1.714 million shares on September 18, 2025, while experiencing a net reduction of 1.861 million shares over the past five trading days [1] - Over the last 20 trading days, southbound funds have reduced their holdings in Fosun Pharma for 15 days, resulting in a total net reduction of 26.2152 million shares [1] - As of now, southbound funds hold 321 million shares of Fosun Pharma, accounting for 58.07% of the company's total issued ordinary shares [1] Group 2 - The total number of shares held by southbound funds on September 18, 2025, was 321 million, reflecting a change of 1.714 million shares, or an increase of 0.54% [2] - On September 17, 2025, the total shares held decreased by 4.086 million shares, representing a decline of 1.27% [2] - Fosun Pharma operates in five segments, including pharmaceuticals, medical devices and diagnostics, healthcare services, pharmaceutical distribution and retail, and other pharmaceutical-related businesses [2]