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复星医药接力攻坚甘露特纳临床研究,积极布局阿尔茨海默病治疗领域
Hua Xia Shi Bao· 2025-12-24 04:12
Core Viewpoint - The Alzheimer's treatment drug, Ganluo Sodium Capsule, is entering a new phase under Fosun Pharma after facing scientific scrutiny and market challenges, with plans for post-marketing confirmatory clinical trials approved by the National Medical Products Administration (NMPA) [1][2]. Group 1: Clinical Development and Market Position - Fosun Pharma has announced a post-marketing confirmatory clinical trial plan for Ganluo Sodium Capsule, with an increased sample size of 1,950 participants, aiming for completion by the end of 2027 and data release in early 2029 [1][2]. - The drug was conditionally approved for marketing in November 2019 and has since benefited hundreds of thousands of patients, with sales exceeding 1 billion yuan since its inclusion in the national medical insurance catalog in 2021 [1][2]. - The price of the drug decreased from 895 yuan to 296 yuan after being included in the national medical insurance catalog, with over 2 million boxes expected to be sold in 2024 alone [1]. Group 2: Scientific and Regulatory Challenges - The drug faced challenges due to the NMPA not approving the extension of its conditional marketing authorization, leading to a supply interruption and various criticisms [2]. - Prior to conditional approval, Ganluo Sodium Capsule completed phase III confirmatory clinical trials with 818 participants across 34 clinical research centers, and real-world studies involving 3,300 participants have been submitted to validate its long-term safety and efficacy [3]. Group 3: Market Demand and Strategic Response - Alzheimer's disease has become a significant public health challenge in China, with nearly 17 million patients reported in 2021, representing 29.8% of global cases [4]. - The existing treatment options are limited and primarily symptomatic, highlighting a substantial unmet clinical need for effective therapies [4][5]. - The Chinese government is encouraging innovation in drug development, aligning with Fosun Pharma's strategic focus on addressing unmet clinical needs in the Alzheimer's treatment space [5]. Group 4: Company Capabilities and Future Outlook - Fosun Pharma's confidence in taking over the Ganluo Sodium project stems from its proven integrated capabilities in research, clinical trials, and commercialization, with ongoing investments in CNS-related products [6]. - The company has successfully launched several innovative drugs in China and is expanding its clinical and commercial teams in the U.S. to support global market entry [6]. - If clinical results are positive, Ganluo Sodium could re-enter the market post-2029, enhancing Fosun Pharma's capabilities in CNS diseases and attracting further collaborations [7].
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
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].
复星医药收购绿谷制药,14亿豪赌阿尔茨海默病市场
Guan Cha Zhe Wang· 2025-12-18 13:53
Core Viewpoint - The acquisition of Green Valley Pharmaceutical by Fosun Pharma is a strategic move to gain control over the Alzheimer's drug "Jiuyiqi" (Mannose Sodium Capsules), which has faced regulatory challenges and production halts, reflecting both potential opportunities and significant risks in the CNS disease market [1][3][4]. Company Summary - Fosun Pharma plans to invest approximately 1.412 billion RMB to acquire a 53% stake in Green Valley Pharmaceutical, which will be consolidated into Fosun's financial statements post-acquisition [1]. - The core asset of this acquisition is the drug "Jiuyiqi," which has been halted from commercial production due to regulatory issues, specifically the expiration of its drug registration certificate in November 2024 [1][4]. - Green Valley's revenue for the first three quarters of 2025 was only 102 million RMB, with a net loss of 67.61 million RMB, indicating a significant decline in its financial health [1][4]. Industry Summary - The Alzheimer's drug market is characterized by high unmet clinical needs, with approximately 17 million patients in China and projected social costs reaching 3.2 trillion RMB by 2030 [9]. - "Jiuyiqi" has been surrounded by controversy regarding its efficacy and regulatory compliance, leading to a halt in its production and a rise in black market activity due to supply shortages [4][5]. - The acquisition is part of Fosun's broader strategy to enhance its portfolio in the CNS disease sector, which includes investments in diagnostic and therapeutic technologies [6][7].
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]
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].