【复星医药：甘露特钠胶囊累计销售19.2亿元 2029年上半年递交总结报告】12月23日，针对上交所监管 工作函，复星医药（600196.SH）进行了回复。公告显示，自2019年获批上市以来，治疗阿尔茨海默病 （AD）的甘露特钠胶囊累计销售额为19.2亿元，累计销售数量为677.11万盒。 上市后确证性临床试验方案计划入组患者1950例。截至2025年12月15日，已累计入组580例、尚需入组 1370例。基于该项目临床方案预估，2027年年底全部受试者可完成入组，2029年年初可完成相关研究并 读出数据，2029年上半年向国家药监局递交临床试验总结报告等资料。中经记者 晏国文 卢志坤 北京报 道 12月15日，复星医药方面披露，拟出资14.12亿元投资控股绿谷医药。甘露特钠胶囊是绿谷医药的核心 产品。不过，自2024年11月起，甘露特钠胶囊未开展商业化生产。因此甘露特钠胶囊在2025年的销售受 到较大影响。 复星医药公告显示，2024年，甘露特钠胶囊原药品注册批件5年有效期到期前，标的公司（绿谷医药） 向监管机构提交关于批准文号有效期事项的补充申请，但因前述上市后确证性临床研究仍在进行中，尚 未完成，根据药 ...

Core Viewpoint - Fosun Pharma has reported significant sales figures for its Alzheimer's treatment, Ganluo Sodium Capsules, but faces challenges in future commercialization due to regulatory hurdles and ongoing clinical trials [2][3]. Sales Data Summary - The cumulative sales amount for Ganluo Sodium Capsules since its approval in 2019 has reached 1.92 billion RMB, with total sales quantity at 6.7711 million boxes [2]. - Sales figures from 2019 to 2025 show a fluctuating trend, with a peak in 2020 at 458.84 million RMB and a notable drop in 2022 to 182.78 million RMB, followed by a recovery to 377.73 million RMB in 2023 [2]. Investment and Regulatory Challenges - Fosun Pharma plans to invest 1.412 billion RMB to gain controlling interest in Green Valley Pharmaceutical, the producer of Ganluo Sodium Capsules [3]. - Starting from November 2024, Ganluo Sodium Capsules will not be commercially produced, significantly impacting sales projections for 2025 [3]. - The company is currently engaged in post-marketing confirmatory clinical trials, with 580 out of 1950 planned patients enrolled as of December 15, 2025, indicating a long timeline for completion and regulatory approval [3].

Core Viewpoint - Fosun Pharma's proposed acquisition of Green Valley Pharmaceutical for 1.412 billion yuan has unexpectedly led to a decline in the company's stock price and a regulatory inquiry from the Shanghai Stock Exchange [2]. Group 1: Acquisition Details - The acquisition involves a combination of "acquiring existing equity + subscribing to new registered capital," with the payment structured in installments: an initial payment of 635 million yuan at the time of closing, followed by another 635 million yuan within three years based on the target company's R&D progress [3]. - Fosun Pharma aims to secure the rights to the main product, the mannitol sodium capsule, which has faced efficacy controversies since its conditional approval in November 2019 for treating mild to moderate Alzheimer's disease [2][3]. Group 2: Clinical Trial and Regulatory Aspects - The mannitol sodium capsule's commercial production is contingent upon completing ongoing post-marketing confirmatory clinical trials and obtaining approval from the National Medical Products Administration (NMPA) [4]. - Fosun Pharma has not identified any unresolved core technical issues or substantial obstacles in advancing the confirmatory clinical trials [4]. - The revised clinical trial protocol, which extends the double-blind treatment period from 36 weeks to 48 weeks and increases the sample size from 1,312 to 1,950 participants, has been approved by the NMPA [5]. - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with projections indicating that all participants could be enrolled by the end of 2027 and data could be available by early 2029 [5].

Core Viewpoint - The acquisition of Green Valley Pharmaceutical by Fosun Pharma for 1.412 billion yuan has led to a significant drop in the company's stock price and triggered regulatory scrutiny from the Shanghai Stock Exchange [3][4]. Group 1: Acquisition Details - Fosun Pharma aims to acquire Green Valley Pharmaceutical primarily to obtain the Alzheimer's drug, Ganluo Sodium Capsule, which has faced efficacy controversies since its conditional approval in November 2019 [3][4]. - The acquisition involves a combination of "acquiring existing equity + subscribing to new registered capital," with a phased payment structure: an initial payment of 635 million yuan at closing, followed by another 635 million yuan based on the target company's R&D progress over three years [5]. - The founder-controlled entity of Green Valley will pledge 10% of the company's shares to secure potential losses from the acquisition, enhancing transaction safety [5]. Group 2: Clinical Trial Progress - Fosun Pharma has communicated that the clinical trial for Ganluo Sodium Capsule is being revised to meet the latest regulatory standards, extending the double-blind treatment period from 36 weeks to 48 weeks and increasing the sample size from 1,312 to 1,950 participants [6]. - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with projections indicating that all participants could be enrolled by the end of 2027, and data could be available by early 2029 [7].

Core Viewpoint - Fosun Pharma's proposed acquisition of Green Valley Pharmaceutical for 1.412 billion yuan has unexpectedly led to a significant decline in the company's stock price and triggered a regulatory inquiry from the Shanghai Stock Exchange [1] Group 1: Acquisition Details - The acquisition involves a total investment of 1.412 billion yuan aimed at acquiring Green Valley Pharmaceutical [1] - Fosun Pharma's response to the regulatory inquiry addressed the specifics of the transaction, the clinical progress of the Alzheimer's disease (AD) drug, and future integration plans [1] Group 2: Product Information - The key product involved in this acquisition is the mannitol sodium capsule, which is Green Valley Pharmaceutical's main offering [1] - This drug received conditional approval from the National Medical Products Administration in November 2019 for the treatment of mild to moderate Alzheimer's disease, marking it as the first AD treatment drug approved globally in 17 years since the approval of Donepezil in 2002 [1]

Core Viewpoint - The acquisition of Green Valley Pharmaceutical by Fosun Pharma has led to a significant decline in the company's stock price and regulatory scrutiny, primarily due to concerns surrounding the clinical efficacy and commercialization of the Alzheimer's drug, Manluotena Capsules [1][2]. Group 1: Acquisition Details - Fosun Pharma plans to acquire Green Valley Pharmaceutical for a total of 14.12 billion yuan, using a combination of stock transfer and subscription to new registered capital, with payments made in installments [2]. - The first payment of 635 million yuan will be made on the closing date, with the remaining amount to be paid over three years based on the target company's R&D progress [2]. - The founder-controlled entity of the target company will pledge 10% of its shares to provide collateral for potential risks, enhancing the security of the transaction [2]. Group 2: Clinical Trial Progress - Manluotena Capsules, initially approved in November 2019, have faced efficacy controversies and require completion of post-marketing confirmatory clinical trials to resume commercialization [1][2]. - The clinical trial protocol has been revised to extend the double-blind treatment 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]. - As of December 15, 2025, 580 participants have been enrolled in the clinical study, with projections indicating that enrollment will be completed by the end of 2027 and data readout by early 2029 [4].

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].

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].

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]

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].