Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [2]

Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [2]

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: 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]

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 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]

Group 1: Regulatory Actions - Shanghai Municipal Drug Administration reported six typical cases of violations in the pharmaceutical and medical device sectors, emphasizing strict enforcement of drug safety regulations [1] - Cases included unauthorized retail of drugs, non-compliance with quality management standards, and unlicensed activities related to medical devices [1] Group 2: Healthcare Financing Innovations - The National Healthcare Security Administration announced that Jiangxi province has implemented a direct settlement model for medical payments, reducing the payment cycle from 180 days to 30 days, significantly improving cash flow for pharmaceutical companies [2] - As of July 2025, Jiangxi's healthcare departments have directly settled payments with pharmaceutical companies totaling approximately 296.42 billion yuan, with 99.73 billion yuan settled in 2025 alone [2] Group 3: Drug Approvals - The FDA approved two biosimilars developed by Fuhong Hanlin for the treatment of osteoporosis, targeting specific patient populations [3] - Zai Lab received approval for TIVDAK (维替索妥尤单抗) in Hong Kong for treating recurrent or metastatic cervical cancer in adults [4] - Hansoh Pharmaceutical announced the approval of a second indication for its drug, Yina Li (伊奈利珠单抗), for adult patients with IgG4-related disease [5] Group 4: Capital Market Activities - Nanwei Medical reported a cumulative buyback of approximately 110,000 shares, representing 0.0585% of its total share capital, with a total expenditure of about 9.6 million yuan [6] - Olin Bio announced the termination of a 175 million yuan private placement due to current market conditions, stating that it would not adversely affect its operations [7][8] Group 5: Strategic Collaborations - Koyi Pharmaceuticals entered into an exclusive licensing agreement with RADIANCE Biopharma for its first-in-class dual antibody ADC drug, KY-0301, with potential milestone payments totaling up to 1.5 billion USD [8][9]

Core Viewpoint - Henlius has received FDA approval for two biosimilar products, BILDYOS® and BILPREVDA®, which are biosimilars to PROLIA® and XGEVA®, respectively, covering all indications approved for the original products in the U.S. [1] Group 1 - The FDA approved BILDYOS® (60mg/mL) for five indications, including osteoporosis [3] - The FDA approved BILPREVDA® (120mg/1.7mL) for three indications, including bone-related events [3] - This marks Henlius's third product approved in the U.S. [3] Group 2 - The approval reflects Henlius's commitment to scientific excellence and product quality [1] - The collaboration with Organon aims to enhance the accessibility of high-quality biologics for U.S. patients [1]

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]