FOSUNPHARMA(02196)

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一周医药速览(09.15-09.19)
Cai Jing Wang· 2025-09-19 09:11
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]
复星医药子公司两个地舒单抗注射液获欧盟注册批准
Bei Jing Shang Bao· 2025-09-19 09:07
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]
复星医药(600196.SH):两个地舒单抗注射液产品获欧盟注册批准
智通财经网· 2025-09-19 08:32
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]
复星医药:两个地舒单抗注射液产品获欧盟注册批准
Zhi Tong Cai Jing· 2025-09-19 08:32
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]
复星医药(600196) - 复星医药关于控股子公司药品获欧盟注册批准的提示性公告

2025-09-19 08:30
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 ...
复星医药:控股子公司两个地舒单抗注射液产品获欧盟注册批准
Zheng Quan Shi Bao Wang· 2025-09-19 08:24
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]
复星医药:复宏汉霖药品获欧盟批准上市
Xin Lang Cai Jing· 2025-09-19 08:16
复星医药公告,控股子公司复宏汉霖及其控股子公司自主研发的地舒单抗注射液产品BILDYOS (规格 60mg/mL)和BILPREVDA (120mg/1.7mL)的上市许可申请获欧盟委员会批准。该产品适用于骨折高 风险的绝经后妇女及男性骨质疏松症治疗、前列腺癌男性与激素消融相关的骨质流失治疗、与长期全身 糖皮质激素治疗相关骨质流失的治疗,以及预防成人晚期骨恶性肿瘤的骨相关事件和不可手术切除或手 术切除后可能导致严重功能障碍的骨巨细胞瘤患者的治疗。截至2025年7月,集团针对HLX14的累计研 发投入约为人民币3.23亿元。2024年,地舒单抗注射液产品于全球范围的销售额约为74.63亿美元。 ...
复星医药(600196.SH):控股子公司药品获欧盟注册批准
Ge Long Hui A P P· 2025-09-19 08:16
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]
复星医药:控股子公司药品获欧盟注册批准
Mei Ri Jing Ji Xin Wen· 2025-09-19 08:16
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]
复星医药等成立康复医院公司,含养老服务业务
Sou Hu Cai Jing· 2025-09-19 04:42
| 序号 | 股东各称 | 持股比例: | 认歌出演藝 : | | 认徽出资日期: 首次特股日期: 关联产品/机 | | | --- | --- | --- | --- | --- | --- | --- | | - 12 | "州乐直医疗投资有限公司 大战车 | 60.0096 | 4800万元 | 2026-08-31 | 2025-09-16 | | | 日 25 | 上海复盘平爆投资管理有限公司 | 20.00% | 1600万元 | 2026-08-31 | 2025-09-16 | 发型医药 | | 股东 | 二夜 上海如显医药(皇国) 股份有限公司 | 100% | 1000万元 | 2007-03-21 | | | | | 广州泰波康复出院营理有限公司 | 20.00% | 1600万元 | 2026-08-31 | 2025-09-16 | | 企查查APP显示,近日,广州乐谷健嘉康复医院有限公司成立,法定代表人为郑淳键,注册资本为8000 万元,经营范围包含:第一类医疗器械销售;健康咨询服务(不含诊疗服务);远程健康管理服务;养 老服务;医院管理等。企查查股权穿透显示,该公司由广州乐宜医疗 ...