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被饶毅打假的“神药” 复星高管回应为何巨额收购
经济观察报· 2025-12-17 05:11
Core Viewpoint - Fosun Pharma is optimistic about the potential of the Alzheimer's drug "971," expecting it to complete clinical trials by the end of 2028, receive approval in the first half of 2029, and enter health insurance by 2030, with peak sales projected to reach approximately 4 billion yuan by 2035 [1][2][5]. Group 1: Acquisition and Financial Implications - Fosun Pharma announced plans to invest approximately 1.412 billion yuan to acquire a 51% stake in Green Valley Pharmaceutical, known for the drug "971" [2]. - Following the acquisition announcement, Fosun Pharma's stock fell by 4.22% in A-shares and 5.81% in Hong Kong, indicating market skepticism regarding the decision [3]. - The overall cost for the domestic Phase III clinical trial is estimated to be 685 million yuan, with additional funding planned based on progress [6]. Group 2: Clinical Trial and Regulatory Path - The clinical trial for "971" will be conducted in collaboration with Green Valley Pharmaceutical, with a target of enrolling over 1,900 patients [6][7]. - The expected timeline for completing the registration-confirmatory Phase III clinical trial is by the end of 2028, with a streamlined approval process anticipated to take about 5 to 6 months [6][7]. - The drug's target patient population is estimated to be around 3.56 million, with a market penetration rate projected at 22% [7]. Group 3: Efficacy Controversies - The efficacy of "971" has faced significant scrutiny, with notable criticisms from scholars regarding its mechanism of action and clinical trial data [9][11]. - Despite the controversies, Fosun Pharma maintains confidence in the drug's effectiveness, citing clinical data from over 800 patients that reportedly show better results than placebo [9][12]. - The drug's commercial potential remains strong, with high demand leading to inflated prices in the market, significantly above previous insurance prices [12][13]. Group 4: Company Background and Future Outlook - Green Valley Pharmaceutical, founded by Lü Songtao, has a history of controversial products, but "971" has been a focal point of its business strategy [15][16]. - Following the acquisition, Green Valley will become a subsidiary of Fosun Pharma, with its future operations primarily focused on clinical trials [16]. - The financial impact of Green Valley's operations on Fosun Pharma's overall financials is expected to be minimal in the short term, as the focus will be on completing the necessary clinical work [16].
被饶毅打假的“神药” 复星高管回应为何巨额收购
Jing Ji Guan Cha Wang· 2025-12-17 04:33
经济观察报 记者 刘晓诺 一款曾被知名学者饶毅炮轰为"假药"的阿尔茨海默病(AD)药物,近期又重获上市销售的可能。 12月15日,复星医药(600196.SH/02196.HK)公告,拟出资约14.12亿元,收购绿谷(上海)医药科技有限公司(下称"绿谷医药")51%的股权。 绿谷医药以甘露特钠胶囊(俗称"971")闻名,这款治疗轻度至中度阿尔茨海默病的创新药于2019年在中国获批附条件上市,打破了全球17年间无AD药物上 市的纪录。2024年,971在中国卖出200多万盒。 但各界对971的质疑从未间断。2025年,因绿谷医药未完成上市后确证性临床研究,国家药监局没有重新批准971的上市申请,该药停产。 12月15日晚间,复星医药高管在电话会上表示,根据现有临床证据,他们看好971的疗效与前景。 接下来,复星医药将推动971的上市后确证性临床试验。按复星医药最乐观的计划,这款药物2029年上半年获批、2030年进入医保,销售峰值预计在2035年 达到约40亿元。 资本市场对交易反应强烈。这次收购是2025年4月新上任的复星医药董事长陈玉卿上任后的第一笔收购,部分股民对其决策合理性提出疑问。12月16日,复 星 ...
控股绿谷医药 复星医药勇闯AD“死亡谷”
Bei Jing Shang Bao· 2025-12-16 16:19
停产危机后,九期一将易主复星医药。 12月16日,复星医药抛出一则让医药圈震动的消息,控股子公司复星医药产业拟出资约14.12亿元控股 收购绿谷医药,从而将绿谷医药核心产品甘露特钠胶囊(商品名:"九期一")收入囊中。 阿尔茨海默病(AD)有医药研发"死亡谷"之称。而2019年获批的九期一正是一款AD的治疗药物,曾被 市场寄予厚望,被认为填补了阿尔茨海默病领域17年无新药上市的空白。不过,随着九期一再注册申请 未获批准,目前该药物已停产(商业化)。由于停销核心产品,绿谷医药今年前三季度净利已出现亏 损。截至9月30日,绿谷医药净资产仅为1036万元。 复星医药相关负责人表示,此次14.12亿元的交易对价,主要是用于九期一后续的研发与临床试验。此 次收购完成后,将持续有序推进该药品的上市后确证性临床试验,以使该药品尽快获得国家药品审评部 门批准。 将控股绿谷医药 复星医药最新公告显示,控股子公司复星医药产业拟出资共计14.12亿元控股投资绿谷医药。其中,复 星医药产业拟出资1.43亿元受让转让方合计持有的标的公司2015万元注册资本。同时,复星医药产业拟 出资12.69亿元认缴标的公司约2.01亿元新增注册资本。 ...
复星医药拟14亿元收购绿谷医药
Zheng Quan Ri Bao· 2025-12-16 16:15
Core Viewpoint - Shanghai Fosun Pharmaceutical plans to invest approximately 1.412 billion yuan to acquire a controlling stake in Green Valley (Shanghai) Pharmaceutical Technology, making it a subsidiary and integrating its core drug, Manluo Sodium Capsule, into Fosun's innovative drug pipeline [1] Group 1: Acquisition Details - The acquisition will allow Fosun Pharmaceutical to control Green Valley Pharmaceutical, with the core product, Manluo Sodium Capsule (marketed as "Jiuqi Yi"), being included in its innovative drug pipeline [1] - Following the announcement, there has been significant market attention and investor concern regarding the efficacy and value of "Jiuqi Yi" in relation to the acquisition price of 1.412 billion yuan [1] Group 2: Product Background - "Jiuqi Yi" was conditionally approved for sale in November 2019 for treating mild to moderate Alzheimer's disease and is the first drug targeting the gut-brain axis mechanism for this condition [2] - The drug's registration certificate will expire in November 2024, and the National Medical Products Administration has not approved its re-registration application, leading to a halt in production and sales after existing inventory is depleted [2] - The drug's mechanism, which involves adjusting gut microbiota rather than directly acting on the brain, has been a subject of controversy, raising questions about its clinical data support [2] Group 3: Clinical Trial and Market Response - A clinical trial published in March 2021 indicated that "Jiuqi Yi" showed significant cognitive improvement in patients with mild to moderate Alzheimer's, particularly in moderate cases [3] - Despite the controversy, some patients have expressed positive feedback about "Jiuqi Yi," with many requesting continued access to the drug after its production halt [2][3] - Fosun Pharmaceutical aims to conduct post-marketing confirmatory clinical trials for "Jiuqi Yi" to seek approval, with ongoing efforts to advance these studies [3] Group 4: Strategic Implications - The acquisition is part of Fosun Pharmaceutical's strategy to enhance its portfolio in the neurodegenerative disease sector, which includes a combination of drugs and devices for treatment [4] - The company emphasizes the significant clinical demand in the neurodegenerative disease field and is committed to supporting the confirmatory clinical research for Manluo Sodium Capsule [4]
郭广昌14亿押注国产阿尔茨海默病“神药”,监管函先来了
Xin Lang Cai Jing· 2025-12-16 12:51
炒股就看金麒麟分析师研报,权威,专业,及时,全面,助您挖掘潜力主题机会! 来源:财通社 在核心产品停产、再注册受挫的背景下,复星医药拟控股收购绿谷医药,引发市场高度关注。 交易尚未落地,上交所即下发监管工作函。 围绕监管审批、产品前景与经营现实,这笔收购正被置于放大镜下审视。 01 控股收购案被关注 昨日傍晚,商业大佬郭广昌实控的复星医药(600196.SH,02196.HK)发布了一则对外投资公告。 相关退股成本由绿谷医药先行垫付,后续通过注册资本转让及转让价格安排在复星医药与吕松涛之间分 摊。 本次收购完成后,复星医药将通过复星医药产业及SPV合计持有绿谷医药53%股权,绿谷医药纳入合并 报表。 若后续吕松涛受让复星医药产业所持SPV股权,则复星医药间接持有绿谷医药51%的股权,其依然并 表。 值得注意的是,公告明确了重要的时间节点: 若未能在2026年1月31日或另行约定时间前完成交割,复星医药产业有权单方面终止交易,并将已取得 的股权转回原转让方或绿谷医药。 今天上午,上交所就该对外投资事项向复星医药下发监管工作函,具体内容未披露。 投资人为复星医药控股子公司复星医药产业发展有限公司(下称"复星医药产 ...
14亿控股绿谷医药,复星医药“豪赌”阿尔茨海默症“神药”?
Xin Lang Cai Jing· 2025-12-16 12:40
Core Viewpoint - Fosun Pharma announced plans to invest approximately 1.412 billion yuan to acquire Green Valley Pharmaceutical, aiming to integrate the latter's Alzheimer's treatment drug, Manluo Sodium Capsule, into its innovative drug pipeline. This move reflects Fosun Pharma's strategy to accelerate its transition from generic to innovative drugs and seek a revaluation in the capital market [1][15]. Acquisition Details - Fosun Pharma's subsidiary, Fosun Pharma Industry, will invest a total of 1.412 billion yuan to acquire control of Green Valley Pharmaceutical, which will become a subsidiary of Fosun Pharma. The transaction includes a capital transfer of 143 million yuan for 15.15 million yuan of registered capital and an additional 1.27 billion yuan for 2.009 billion yuan of new registered capital [2][16]. - After the acquisition, Fosun Pharma will hold 53% of Green Valley's shares, with plans to reduce this to 51% after further share transfers. Green Valley focuses on developing, producing, and selling drugs for neurodegenerative diseases, with its core product, Manluo Sodium Capsule, conditionally approved for Alzheimer's treatment in November 2019 [3][16]. Controversies Surrounding the Drug - Manluo Sodium Capsule has faced significant controversy since its launch, with questions regarding its mechanism of action and clinical efficacy. The drug's registration has expired, and it will not resume commercial production until it completes ongoing post-marketing confirmatory clinical trials and receives approval from regulatory authorities [4][17]. - Due to the halt in sales of its core product, Green Valley's financial performance has been adversely affected, reporting revenues of 572 million yuan in 2024 and a net profit of 70.77 million yuan, followed by a loss of 67.61 million yuan in the first nine months of 2025 [5][17]. Market Reaction - Following the acquisition announcement, Fosun Pharma's stock fell significantly, with a drop of over 9% at one point in Hong Kong, closing down 5.81% at 21.06 HKD per share, and a decline of 4.22% in A-shares, closing at 26.75 yuan per share [5][18]. Strategic Moves in Innovative Drugs - Fosun Pharma has been actively expanding its innovative drug portfolio through various strategies, including partnerships and licensing agreements. For instance, in July, it signed a licensing agreement with Newco for the development of AR1001, another drug targeting Alzheimer's disease [6][19]. - The company has also made significant investments in its cell therapy platform, acquiring full ownership of Fosun Kite and planning further capital injections to enhance its capabilities in oncology [6][20]. Financial Performance and Challenges - Fosun Pharma's financial performance has shown mixed results, with revenues of 439.52 billion yuan in 2022, declining to 410.67 billion yuan in 2024. The company reported a net profit of 25.23 billion yuan in the first three quarters of 2024, reflecting a year-on-year decline of 4.91% in revenue [10][22]. - The company has faced scrutiny regarding its financial health, with short-term borrowings reaching 16.447 billion yuan and cash reserves insufficient to cover these debts, indicating potential liquidity pressures [11][24]. Future Prospects - The success of the acquisition and the potential re-approval of Manluo Sodium Capsule remain uncertain, raising questions about its contribution to Fosun Pharma's future performance [13][24].
14.12亿元控股绿谷医药,复星医药勇闯AD“死亡谷”
Bei Jing Shang Bao· 2025-12-16 12:03
Core Viewpoint - Fosun Pharma is set to acquire a controlling stake in Green Valley Pharmaceutical for approximately 1.412 billion yuan, aiming to advance the development of the Alzheimer's drug, Ganluo Sodium Capsule, which has faced regulatory challenges and halted production [1][3][6]. Group 1: Acquisition Details - Fosun Pharma's subsidiary plans to invest 1.43 billion yuan to acquire existing shares and 12.69 billion yuan for new capital, resulting in a 53% ownership stake in Green Valley [3][8]. - The acquisition is structured to address existing employee stock incentive plans and involves a transfer of shares at minimal cost to facilitate the deal [3][8]. Group 2: Product Background - Ganluo Sodium Capsule, approved in 2019 for treating mild to moderate Alzheimer's disease, has been recognized for its potential to improve cognitive function but has faced setbacks in commercial production due to regulatory issues [4][6]. - The drug's commercial production has ceased, and Green Valley reported a net loss of 6.761 million yuan in the first three quarters of the year, with total liabilities reaching 795 million yuan [7][8]. Group 3: Market Potential and Strategy - The Alzheimer's treatment market presents significant growth opportunities, with global sales projected at approximately 2.094 billion USD in 2024, while the Chinese market is expected to reach 1.244 billion yuan [10]. - Fosun Pharma aims to leverage this acquisition to enhance its product pipeline in the central nervous system treatment sector, addressing unmet clinical needs and expanding its market presence [11][13]. Group 4: Clinical Development Focus - The success of the acquisition hinges on the completion of confirmatory clinical trials for Ganluo Sodium Capsule, which are essential for regulatory approval and market re-entry [9][12]. - Fosun Pharma plans to conduct international multi-center studies to bolster the drug's academic credibility and support future market access [9][12].
复星医药斥资14亿进军阿尔茨海默病领域
Guo Ji Jin Rong Bao· 2025-12-16 11:21
Core Viewpoint - Fosun Pharma announced the acquisition of a 53% stake in Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd. for approximately 1.412 billion yuan, making it a subsidiary of Fosun Pharma. This acquisition is a strategic move to enhance its presence in the central nervous system treatment sector, particularly focusing on Alzheimer's disease [1][2]. Group 1: Acquisition Details - The acquisition aims to integrate Green Valley's core product, Manzhuan Sodium Capsules (brand name "Jiuqi Yi"), into Fosun Pharma's innovative drug pipeline, targeting mild to moderate Alzheimer's disease [1][2]. - Fosun Pharma plans to support the post-marketing confirmatory clinical research for Manzhuan Sodium Capsules to expedite its approval process [1][3]. Group 2: Product and Market Context - Manzhuan Sodium Capsules are derived from marine brown algae and were conditionally approved as a Class 1 new drug by the National Medical Products Administration in November 2019 for improving cognitive function in Alzheimer's patients [2]. - The product was included in the national medical insurance catalog in 2021, but due to incomplete post-marketing confirmatory clinical research, the drug's registration certificate will expire in November 2024, halting commercial production [2]. Group 3: Future Plans and Research - Fosun Pharma intends to enhance its research and development efforts, focusing on comprehensive management treatment solutions that include early screening, medical diagnosis, drug intervention, and non-invasive treatment devices [2]. - The company is committed to conducting the necessary post-marketing confirmatory clinical trials under the guidance of drug regulatory authorities to ensure the quality and integrity of the trial data [3].
14.12亿接手争议“神药”,复星医药收购绿谷医药是机遇还是风险?
Xin Lang Cai Jing· 2025-12-16 09:15
Core Viewpoint - Fosun Pharma announced plans to invest approximately 1.412 billion yuan to acquire a controlling stake in Green Valley Pharmaceutical, focusing on the controversial Alzheimer's drug "Jiuyi Yi" (Guanlu Sodium Capsules) amidst Green Valley's negative net profit and production halt due to expired drug registration [1][6]. Financial Summary - As of the valuation reference date, Green Valley's total assets amounted to 806 million yuan, with liabilities of 795 million yuan, resulting in a mere equity of 10.36 million yuan [2][7]. - Fosun Pharma's total investment of 1.412 billion yuan will grant it a 53% stake in Green Valley, with the latter's valuation reaching 1.674 billion yuan post-transaction [2][7]. Regulatory and Compliance Issues - Green Valley has faced regulatory penalties for commercial bribery, with a fine of 400,000 yuan for conducting 587 illegal meetings to promote drug sales, involving a total of 833,400 yuan [2][7]. Market Reaction - Following the acquisition announcement, Fosun Pharma's stock fell by 5.81% in Hong Kong and 4.22% in A-shares, indicating investor skepticism regarding the acquisition [3][8]. Strategic Considerations - The Alzheimer's market presents significant potential, with nearly 17 million patients in China and a lack of effective treatment options. Fosun Pharma aims to enhance its pipeline in the central nervous system sector through this acquisition [4][10]. - Prior to its production halt, "Jiuyi Yi" had benefited hundreds of thousands of patients, with some doctors having practical prescription experience, suggesting a potentially high market acceptance if the product can be relaunched [4][10]. Risks and Challenges - The acquisition carries substantial clinical and regulatory risks, as "Jiuyi Yi" is still under conditional approval and must complete post-marketing confirmatory clinical trials to resume production [4][10]. - Financial and integration pressures are significant, with Green Valley on the brink of insolvency and Fosun Pharma needing to invest further in clinical trials while managing potential R&D failures [4][10]. - The drug has been embroiled in controversy, with doubts about its efficacy, which could impact Fosun Pharma's overall strategy and brand reputation in the central nervous system domain if regulatory approval is not achieved [5][11].
港股异动丨复星医药一度跌超9%,拟收购面临争议药物开发商
Ge Long Hui· 2025-12-16 07:32
外媒称,绿谷医药今年早些时候表示,其阿尔茨海默病药物的注册证书已到期,续期正处于监管审批的 最后阶段。这一动向让外界对该药物的前景产生疑问。 复星医药A股收跌4.22%报26.75元,H股盘中一度跌超9%报20.2港元。消息面上,公司公布,控股子公 司复星医药产业拟出资约14.12亿元人民币收购绿谷医药,其核心药品甘露特钠胶囊,主要用于治疗轻 度至中度阿尔茨海默病。 ...