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生物类似药新突破!复星医药HLX14剑指70亿美元地舒单抗市场
Ge Long Hui· 2025-12-05 01:44
Core Viewpoint - The acceptance of the marketing registration application for HLX14, a biosimilar of denosumab by Fosun Pharma, marks a significant advancement in providing new treatment options for osteoporosis in China, following approvals in Europe and the US [1][3]. Group 1: Product Development and Market Position - Fosun Pharma's subsidiary, Fuhong Hanlin, has submitted a marketing registration application for HLX14, a biosimilar of denosumab, aimed at treating osteoporosis in postmenopausal women and men, as well as glucocorticoid-induced osteoporosis [1]. - The original denosumab, developed by Amgen, has generated over $7 billion in global sales, with a significant presence in the domestic market where it was approved around 2020 and included in the medical insurance directory [3]. - In 2024, the sales of denosumab in the domestic hospital market exceeded 1.8 billion yuan, reflecting a year-on-year growth rate of 57%, and in the first half of 2025, sales surpassed 1.4 billion yuan, with a growth rate of 79.05% [3]. Group 2: Competitive Landscape - The expiration of the original drug's patent has intensified competition in the domestic biosimilar market, with four companies, including Taikang Biopharma and Qilu Pharmaceutical, having received approvals for denosumab biosimilars [5]. - Several other companies, such as Maitaiabo and Haosen Pharmaceutical, are actively advancing their clinical trials for denosumab biosimilars, indicating a clearer competitive landscape in this sector [5]. Group 3: Investment and Future Outlook - As of October this year, Fosun Pharma has invested approximately 320 million yuan in the development of the denosumab injection product, and successful approval of this application could open new growth pathways for the company [11]. - The entry of more biosimilars and improved new drugs in the market is expected to enhance accessibility, treatment options, and long-term management for patients, ultimately benefiting a larger patient population [11].
复星与沙特Fakeeh Care Group达成战略合作
Sou Hu Cai Jing· 2025-12-04 10:36
近日,复星健康与Fakeeh Care Group在沙特吉达正式签署战略合作备忘录。双方围绕专科建设与学术交流、IT与数字化医院解决方案、预防医学与可穿戴设 备、干细胞与再生医学四大核心方向达成战略合作探索意向,为"一带一路"倡议下中沙医疗健康合作注入新活力,也为沙特"2030 愿景"医疗板块升级添砖 加瓦。 近日,复星健康董事长兼首席执行官胡航,复星健康联席总裁、首席战略官沈赟,复星健康副总裁、佛山复星禅诚医院院长赵晓东等领导团队,受邀前往沙 特阿拉伯,对当地领先的私营医疗健康集团Fakeeh Care Group进行实地考察与深度交流。 复星健康领导一行参观了该集团位于吉达的旗舰医院,双方围绕医院规划、学科运营和服务质量等议题展开深入探讨。复星健康董事长兼首席执行官胡航对 Fakeeh Care Group医院体系化的管理、先进设施和高标准服务表示赞赏,期待双方团队紧密协作,推动合作项目扎实落地。Fakeeh Care Group吉达旗舰医院 首席执行官Sohail Bajammal博士表示,沙特医疗市场需求广阔,期待引入复星健康在中国市场的经验与创新模式,共同促进项目在沙成功实施。 随后,在复星健康董事 ...
上海复星医药(集团)股份有限公司关于2025年A股股票期权激励计划首次授予结果公告
证券代码:600196 证券简称:复星医药 公告编号:临2025-190 上海复星医药(集团)股份有限公司关于 2025年A股股票期权激励计划首次授予结果公告 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、完整性承担法律责任。 重要内容提示: ●A股期权首次授予登记日:2025年12月2日 ●A股期权首次授予登记数量:4,446,400份 根据《上海复星医药(集团)股份有限公司2025年A股股票期权激励计划》(以下简称"2025年A股期权 计划"或"本次激励计划")及上海复星医药(集团)股份有限公司(以下简称"本公司")2025年第一次 临时股东会的授权,本次激励计划首次授予及登记工作已完成,现将相关事项公告如下: 一、本次激励计划首次授予情况 2025年11月4日,本公司第十届董事会第十四次会议审议通过关于2025年A股期权计划首次授予相关事 项的议案,董事会认为本次激励计划首次授予的条件已经成就,同意以2025年11月4日作为首次授予 日、向共计195名首次授予激励对象授予合计4,535,100份A股期权,并办理该授予所需的相关事宜。该 议案 ...
复星医药:控股子公司FXS887片获临床试验批准
Zheng Quan Ri Bao Wang· 2025-12-03 13:42
Core Viewpoint - Fosun Pharma has received approval from the National Medical Products Administration for clinical trials of FXS887 tablets for advanced malignant solid tumors [1] Group 1 - Fosun Pharma's subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., is set to conduct Phase I clinical trials of FXS887 in China once conditions are met [1]
复星医药(02196)控股子公司的FXS887片获临床试验批准
智通财经网· 2025-12-03 10:13
Core Viewpoint - Fosun Pharma has received approval from the National Medical Products Administration for clinical trials of FXS0887, an innovative oral small molecule drug aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Trial Approval - Fosun Pharma's subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., has been authorized to conduct Phase I clinical trials of FXS0887 in China once conditions are met [1] - The drug targets advanced malignant solid tumors and specifically inhibits ATR kinase activity, which is involved in cell cycle regulation and DNA damage repair pathways [1] Group 2: Drug Development and Efficacy - FXS0887 has shown promising anti-tumor activity in various tumor models during preclinical studies, with a low risk of off-target effects and good safety profile [1] - As of October 2025, the cumulative R&D investment for FXS0887 is approximately RMB 44 million (unaudited) [1] Group 3: Market Context - As of the announcement date (December 3, 2025), there are no approved small molecule inhibitors targeting the same pathway as FXS0887, either as monotherapy or in combination therapy, globally [1]
复星医药控股子公司的FXS887片获临床试验批准
Zhi Tong Cai Jing· 2025-12-03 10:08
Core Viewpoint - Fosun Pharma has received approval from the National Medical Products Administration for clinical trials of FXS887, an innovative oral small molecule drug aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Trial Approval - Fosun Pharma's subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., has been authorized to conduct Phase I clinical trials of FXS887 in China [1] - The drug is designed to specifically inhibit ATR kinase activity, which is involved in cell cycle regulation and DNA damage repair pathways, thereby suppressing malignant proliferation of tumor cells [1] Group 2: Drug Development and Safety - Preclinical studies have shown that FXS887 exhibits good anti-tumor activity across various tumor models, with a low risk of off-target effects and good safety profile [1] - As of October 2025, the cumulative R&D investment for FXS887 is approximately RMB 44 million (unaudited) [1] Group 3: Market Context - As of the announcement date (December 3, 2025), there are no approved small molecule inhibitors targeting the same pathway as FXS887, either as monotherapy or in combination therapy, globally [1]
复星医药:FXS887片用于晚期恶性实体瘤获临床试验批准
Ge Long Hui· 2025-12-03 10:03
格隆汇12月3日丨复星医药(02196.HK)公告,近日,上海复星医药(集团)股份有限公司(以下简称"公司") 控股子公司上海复星医药产业发展有限公司(以下简称"复星医药产业")收到国家药品监督管理局关于同 意FXS887片(项目代号及以下简称"FXS0887")用于晚期恶性实体瘤开展临床试验的批准。复星医药产业 拟于条件具备后于中国境内1开展FXS0887的I期临床试验。 截至本公告日期(即2025年12月3日),于全球范围内尚无同靶点的小分子抑制剂单药或联合治疗方案获 批上市。 FXS0887为集团(即公司及控股子公司/单位,下同)自主研发的口服小分子创新药物,拟用于治疗晚期恶 性实体瘤。FXS0887可特异性抑制ATR(AtaxiaTelangiectasiaandRad3-related)激酶活性,通过干预细胞周 期调控和DNA损伤修复相关通路,从而抑制肿瘤细胞的恶性增殖。截至目前的临床前研究显示, FXS0887在多种类型肿瘤模型中表现出良好的抗肿瘤活性,脱靶风险较小,安全性良好。截至2025年10 月,集团现阶段针对FXS0887的累计研发投入约为人民币0.44亿元(未经审计)。 ...
复星医药(02196.HK):FXS887片用于晚期恶性实体瘤获临床试验批准
Ge Long Hui· 2025-12-03 10:03
Core Viewpoint - Fosun Pharma has received approval from the National Medical Products Administration for clinical trials of FXS887, an innovative oral small molecule drug aimed at treating advanced malignant solid tumors [1] Group 1: Clinical Development - Fosun Pharma's subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., plans to conduct Phase I clinical trials for FXS887 in China once conditions are met [1] - FXS887 specifically inhibits ATR kinase activity, intervening in cell cycle regulation and DNA damage repair pathways to suppress malignant proliferation of tumor cells [1] Group 2: Preclinical Research - Preclinical studies have shown that FXS887 exhibits good anti-tumor activity across various tumor models, with a low off-target risk and good safety profile [1] - As of October 2025, the cumulative R&D investment for FXS887 is approximately RMB 44 million (unaudited) [1] Group 3: Market Context - As of the announcement date, there are no approved small molecule inhibitors targeting the same pathway as FXS887, either as monotherapy or in combination therapy, globally [1]
复星医药子公司FXS887片临床试验获批
Bei Jing Shang Bao· 2025-12-03 09:57
复星医药表示,截至公告日期,于全球范围内尚无同靶点的小分子抑制剂单药或联合治疗方案获批上 市。 北京商报讯(记者 丁宁)12月3日晚间,复星医药(600196)发布公告称,公司控股子公司上海复星医 药产业发展有限公司(以下简称"复星医药产业")收到国家药品监督管理局关于同意FXS887片用于晚 期恶性实体瘤开展临床试验的批准。复星医药产业拟于条件具备后于中国境内1开展FXS0887的I期临床 试验。 ...
复星医药(02196) - 海外监管公告 - 关於控股子公司药品获临床试验批准的公告
2025-12-03 09:53
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。 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) (股份代號:02196) 海外監管公告 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 控股子公司藥品獲臨床試驗批准的公告》,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1 2 月3 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、王可心先生及劉毅先生;本公 司之非執行董事為陳啟宇先生及潘東輝先生;本公司之獨立非執行董事為余梓山先生、王全弟先生、Chen Penghui先生及楊玉成先生;以及本公司職工董事為嚴佳女士。 * ...