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逾14亿元押注停产“九期一”,何时能重新上市?复星医药回应监管函:预计2029年完成上市后确证性临床试验
Mei Ri Jing Ji Xin Wen· 2025-12-23 05:37
Core Viewpoint - Fosun Pharma is acquiring a controlling stake in Green Valley Pharmaceutical for approximately 14.12 billion RMB, despite the core product, Manzamine Sodium Capsule, being off the market due to regulatory issues. The acquisition has raised concerns in the capital market regarding the timeline for the product's return to commercialization [2][3][4]. Group 1: Acquisition Details - The acquisition will be executed through a combination of stock transfer and subscription to new registered capital, resulting in Fosun Pharma holding 51% of Green Valley Pharmaceutical [4]. - The payment for the acquisition will be made in installments, with an initial payment of 635 million RMB at the time of closing, and the remaining amount contingent on the progress of Green Valley's research and development [4]. - Green Valley's founder will pledge 10% of the company's shares post-acquisition to mitigate potential risks [4]. Group 2: Clinical Trial and Product Timeline - The revised post-marketing confirmatory clinical trial for Manzamine Sodium Capsule has been approved, with full enrollment expected by the end of 2027 and data readout in early 2029 [2][7]. - The product has been off the market since November 2024 due to the expiration of its registration certificate and will require successful completion of the clinical trial and regulatory approval before resuming sales [7][8]. Group 3: Financial and Compliance Status - Green Valley Pharmaceutical has faced regulatory scrutiny, including a 400,000 RMB fine for improper promotional practices, but this has not significantly impacted its operations [9][10]. - An audit revealed no hidden large debts or misuse of funds within Green Valley, indicating a stable financial position prior to the acquisition [10][12]. - As of September 30, 2025, Green Valley's assets and liabilities were 806 million RMB and 795 million RMB, respectively, which have a limited impact on Fosun Pharma's overall financial structure [12]. Group 4: Market Competition and Future Risks - The market for Alzheimer's treatments is competitive, with six other drugs already approved, which may affect the sales performance of Manzamine Sodium Capsule upon its return to the market [8]. - The timeline for the product's re-commercialization has been extended to around 2029, raising concerns about market dynamics and reimbursement conditions at that time [8].
复星医药回应“九期一”热议:确证性临床研究获药审中心认可
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-23 02:32
Core Viewpoint - Fosun Pharma is acquiring a controlling stake in Green Valley Pharmaceutical for approximately RMB 1.412 billion, aiming to integrate its core drug GV-971 into its innovative drug pipeline for Alzheimer's disease treatment [1][2]. Group 1: Acquisition Details - The acquisition involves a combination of "transferring existing equity + subscribing to new registered capital," with Fosun Pharma set to hold 51% of Green Valley's shares [2]. - The total transaction amount of RMB 1.269 billion will be paid in installments, with the first payment of RMB 635 million made on the closing date, and the remaining RMB 634 million to be paid within three years based on the company's R&D progress [2][3]. - The founder-controlled entity of Green Valley will pledge 10% of the company's shares post-acquisition to provide guarantees against potential risks [2]. Group 2: Clinical Trial and Product Development - The acquisition will provide necessary funding for the clinical trials of GV-971 and support its commercialization, including clinical operations, registration, and marketing [3]. - The clinical trial design for GV-971 has been revised to extend the double-blind medication period from 36 weeks to 48 weeks and increase the sample size from 1,312 to 1,950 participants, in accordance with the latest guidelines from the National Medical Products Administration [3][4]. - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with completion of enrollment expected by the end of 2027 and data readout anticipated in early 2029 [4]. Group 3: Strategic Positioning - Fosun Pharma has been focusing on the central nervous system degenerative disease sector, enhancing its product portfolio with a collaborative innovation model that includes both drugs and devices [4][5]. - This acquisition represents a strategic move to address unmet clinical needs in the treatment of Alzheimer's disease, further enriching the company's innovative product pipeline and market positioning [5].
复星医药回应市场关切:甘露特钠胶囊确证性临床研究获药审中心认可,已累计入组580例
Jin Rong Jie· 2025-12-23 01:47
Group 1 - The core point of the news is that Fosun Pharma has announced a strategic acquisition of a controlling stake in Green Valley Pharmaceutical, aiming to enhance its capabilities in the Alzheimer's disease treatment sector through a combination of equity transfer and capital subscription [1] - The acquisition involves a total payment of 1.269 billion yuan, with an initial payment of 635 million yuan at the time of closing, and the remaining 634 million yuan to be paid over three years based on the company's subsequent R&D progress [1] - The acquisition will provide necessary funding for the clinical trials of Ganluo Sodium Capsules and support commercialization efforts, including clinical operations, registration, and marketing [1] Group 2 - Fosun Pharma is committed to the field of neurodegenerative diseases and has developed a collaborative innovation model combining drugs and devices, enhancing its product portfolio with various treatments [3] - The company has revised its post-marketing confirmatory clinical trial plan for Alzheimer's disease, extending the double-blind treatment period from 36 weeks to 48 weeks and increasing the sample size from 1,312 to 1,950 participants, which has been approved by the National Medical Products Administration [2] - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with expectations to complete enrollment by the end of 2027 and submit the clinical trial summary report to the regulatory authority in the first half of 2029 [2]
复星医药 (02196) 回应收购绿谷医药:甘露特钠胶囊确证性临床研究获药审中心认可,已累计入组580例
Zhi Tong Cai Jing· 2025-12-23 01:15
Core Viewpoint - Fosun Pharma has announced a strategic acquisition of 51% stake in Green Valley Pharmaceutical, aimed at enhancing its capabilities in the Alzheimer's disease treatment sector and ensuring funding for clinical trials of the drug Ganluo Sodium Capsule [1][3]. Group 1: Acquisition Details - The acquisition will be executed through a combination of "acquiring existing equity + subscribing to new registered capital," with a total payment of 1.269 billion yuan, structured in installments [1]. - The first payment of 635 million yuan will be made on the closing date, while the remaining 634 million yuan will be paid within three years based on the clinical progress of the target company [1]. - The founder-controlled entity of the target company will pledge 10% of its shares post-acquisition to provide collateral against potential risks [1]. Group 2: Clinical Trial Progress - Fosun Pharma has revised the post-marketing confirmatory clinical trial protocol for the Alzheimer's drug, extending the double-blind treatment period from 36 weeks to 48 weeks and increasing the sample size from 1,312 to 1,950 participants [2]. - As of December 15, 2025, a total of 580 participants have been enrolled in the clinical study, with completion of enrollment expected by the end of 2027 and data readout anticipated in early 2029 [2]. Group 3: Strategic Focus - Fosun Pharma is committed to the field of neurodegenerative diseases, enhancing its product portfolio with a collaborative innovation model that includes both drugs and medical devices [3]. - The acquisition is part of the company's strategy to address unmet clinical needs in this therapeutic area and to further enrich its pipeline of innovative products [3].
复星医药(02196)回应收购绿谷医药:甘露特钠胶囊确证性临床研究获药审中心认可,已累计入组580例
智通财经网· 2025-12-23 00:12
Core Viewpoint - Fosun Pharma is acquiring a 51% stake in Green Valley Pharmaceutical through a combination of stock transfer and capital subscription, with a total investment of 1.269 billion yuan, structured to manage clinical and investment risks effectively [1] Group 1: Acquisition Details - The acquisition involves a phased payment structure, with an initial payment of 635 million yuan at the time of closing and the remaining 634 million yuan to be paid within three years based on the company's subsequent R&D progress [1] - The founder-controlled entity of the target company will pledge 10% of its shares post-acquisition to provide collateral against potential risks [1] Group 2: Clinical Development Progress - Fosun Pharma is revising the post-marketing confirmatory clinical trial protocol for its Alzheimer's drug, extending the double-blind treatment period from 36 weeks to 48 weeks and increasing the sample size from 1,312 to 1,950 participants [2] - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with full enrollment expected by the end of 2027 and data readout anticipated in early 2029 [2] Group 3: Strategic Focus - Fosun Pharma is enhancing its product portfolio in the field of neurodegenerative diseases, having developed a collaborative innovation model that includes both drugs and devices [3] - The acquisition is part of the company's strategy to address unmet clinical needs in this therapeutic area and to further enrich its pipeline of innovative products [3]
复星医药回应收购绿谷医药:甘露特钠胶囊确证性临床研究获药审中心认可,已累计入组580例
Zhi Tong Cai Jing· 2025-12-23 00:11
Core Viewpoint - Fosun Pharma is acquiring a 51% stake in Green Valley Pharmaceutical through a combination of stock transfer and capital subscription, with a total investment of 1.269 billion yuan, structured to manage clinical and investment risks effectively [1][2]. Group 1: Acquisition Details - The acquisition involves a phased payment structure, with an initial payment of 635 million yuan at the time of closing and the remaining 634 million yuan to be paid within three years based on the company's R&D progress [1]. - The founder of the target company will pledge 10% of the company's shares post-acquisition to provide collateral against potential risks [1]. Group 2: Clinical Development - Fosun Pharma is committed to funding the clinical trials for the drug Ganluo Sodium Capsule, which will also be integrated into its innovative drug pipeline [1]. - The clinical trial for Alzheimer's disease has been revised to extend the double-blind medication period from 36 weeks to 48 weeks and increase the sample size from 1,312 to 1,950 participants, in line with the latest regulatory guidelines [2]. Group 3: Strategic Focus - Fosun Pharma is enhancing its product portfolio in the field of neurodegenerative diseases, aiming to address unmet clinical needs and strengthen its market position through a collaborative innovation model that includes both drugs and medical devices [3].
复星医药(02196.HK):12月22日南向资金减持23.4万股
Sou Hu Cai Jing· 2025-12-22 19:25
证券之星消息,12月22日南向资金减持23.4万股复星医药(02196.HK)。近5个交易日中,获南向资金 减持的有3天,累计净减持65.8万股。近20个交易日中,获南向资金增持的有11天,累计净增持97.95万 股。截至目前,南向资金持有复星医药(02196.HK)3.17亿股,占公司已发行普通股的57.48%。 | 交易日 | 持股总数(股) | 持股变动(股) | 变动幅度 | | --- | --- | --- | --- | | 2025-12-22 | 3.17亿 | -23.40万 | -0.07% | | 2025-12-19 | 3.18亿 | -89.20万 | -0.28% | | 2025-12-18 | 3.18亿 | 140.60万 | 0.44% | | 2025-12-17 | 3.17亿 | 45.35万 | 0.14% | | 2025-12-16 | 3.17亿 | -139.15万 | -0.44% | 上海复星医药(集团)股份有限公司是一家主要从事医药产品研发、制造与销售的中国公司。该公司经 营五个分部。制药分部主要从事创新药、成熟医药产品制造和疫苗业务。医疗器械与医 ...
上海复星医药(集团)股份有限公司关于回复上海证券交易所对外投资事项监管工作函的公告
Shang Hai Zheng Quan Bao· 2025-12-22 17:56
Core Viewpoint - Shanghai Fosun Pharmaceutical Group Co., Ltd. is responding to regulatory inquiries regarding its investment in Green Valley Pharmaceutical, particularly focusing on the uncertainties surrounding the commercialization and clinical trials of its main product, Ganluo Sodium Capsules, which is aimed at treating Alzheimer's disease. Group 1: Investment and Financial Aspects - The company plans to invest a total of 14.12 billion yuan to gain controlling interest in the target company [3] - The acquisition is expected to result in significant goodwill, which may be subject to impairment risks if the clinical trials do not meet expectations [3][4] - As of September 30, 2025, the target company reported total assets of 806 million yuan and liabilities of 795 million yuan, indicating a very low equity position [25] Group 2: Product Development and Clinical Trials - Ganluo Sodium Capsules received conditional approval from the National Medical Products Administration (NMPA) in November 2019 for treating mild to moderate Alzheimer's disease [6] - The product's registration certificate is set to expire in November 2024, and the company must complete ongoing post-marketing confirmatory clinical trials to resume commercialization [24] - The ongoing confirmatory clinical trial aims to enroll 1,950 patients, with 580 already enrolled as of December 15, 2025, and is expected to complete by the end of 2027 [19] Group 3: Regulatory Challenges and Market Competition - The NMPA did not approve the extension of the product's registration due to the ongoing clinical trials, which raises uncertainties about the product's future [10] - The market for Alzheimer's treatments is becoming increasingly competitive, with multiple products either already on the market or in development, which could impact the sales of Ganluo Sodium Capsules [3][4] - The company has implemented various risk control measures to address potential issues related to the product's efficacy and safety during the clinical trial process [17] Group 4: Compliance and Legal Issues - The target company faced administrative penalties for improper sales practices, which were confirmed during due diligence, but these penalties have not significantly impacted its operations [29][30] - The company has established a compliance framework to manage marketing activities and ensure adherence to regulatory standards following the acquisition [30]
复星医药(600196) - 复星医药关于回复上海证券交易所对外投资事项监管工作函的公告

2025-12-22 15:00
证券代码:600196 证券简称:复星医药 公告编号:2025-202 上海复星医药(集团)股份有限公司 关于回复上海证券交易所对外投资事项 监管工作函的公告 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。 ●特别风险提示 1、标的公司主要品种甘露特钠胶囊的药品注册证书(有条件批准)于 2024 年 11 月到期,该药品在重新开展商业化生产和销售前,还需(其中主要包括)补充完成目前 尚在开展中的上市后确证性临床试验并通过国家药监局的审评审批、以及获上海药监局 的再注册结论。鉴于该临床试验尚在开展中,该临床试验能否如期完成受试者入组、达 成临床研究终点以及该药品能否如期获国家药品审评部门的批准,尚存在不确定性。 2、截至本回复出具日,甘露特钠胶囊商业化生产和销售已暂停,且未来一段时间 该公司仍将处于对该药品的临床投入阶段,由于目前标的公司无其他在研药品或已上市 产品,若尚在开展中的甘露特钠胶囊上市后确证性临床研究的数据结果未达预期或未获 国家药品审评部门的批准,则标的公司对该药品的前期研发投入将无法收回,预计将对 标的公司持续经 ...
复星医药(02196) - 海外监管公告 - 关於回覆上海证券交易所对外投资事项监管工作函的公告

2025-12-22 14:55
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 回覆上海證券交易所對外投資事項監管工作函的公告》,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12月22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 、 ...