证券日报网讯12月23日，复星医药（600196）在互动平台回答投资者提问时表示，公司坚持"创新驱动 +全球化"战略，创新药方面，聚焦实体瘤、血液瘤、免疫炎症等核心治疗领域，重点强化抗体/ADC、 细胞治疗、小分子等核心技术平台，并积极向心脑血管、肾脏与代谢等慢病领域及中枢神经系统领域拓 展布局，打造协同开放式、全球化的创新研发体系，持续提升管线价值，推动重磅产品的研发及商业 化；在制造与供应链方面，公司持续推进生产体系的整合，强化规模化、有成本竞争力的制造体系，公 司制药板块国内控股子公司所有商业化生产线均已通过国内GMP认证，还有多条生产线通过了美国、 欧洲等主流法规市场的GMP认证，为国际化供应奠定基础。 ...

Core Viewpoint - Fosun Pharma is acquiring a controlling stake in Green Valley Pharmaceutical for approximately 14.12 billion yuan, despite the core product, Manzotai Capsules, being suspended from production and sales. The acquisition has raised concerns in the capital market regarding the timeline for the product's re-entry into the market [1][2]. Group 1: Acquisition Details - Fosun Pharma's acquisition will result in it holding 53% of Green Valley's shares through its subsidiary and a special purpose vehicle (SPV) [2]. - The acquisition involves a combination of stock transfer and subscription to new registered capital, with Fosun Pharma's subsidiary expected to hold 51% of Green Valley's shares [2]. - The payment for the acquisition will be made in installments, with an initial payment of 6.35 billion yuan on the closing date and the remaining amount contingent on Green Valley's future R&D progress [3]. Group 2: Clinical Trial Progress - The revised post-marketing confirmatory clinical trial for Manzotai Capsules has been approved by the National Medical Products Administration, with an estimated completion of subject enrollment by the end of 2027 and data readout in early 2029 [1][4]. - As of December 15, 2025, 580 subjects have been enrolled in the clinical study, with 1,370 more needed to complete the trial [4]. - The clinical trial design has been updated to extend the double-blind treatment period from 36 weeks to 48 weeks and increase the sample size from 1,312 to 1,950 [3]. Group 3: Financial and Compliance Aspects - Green Valley Pharmaceutical has faced administrative penalties for improper promotional practices, resulting in a fine of 400,000 yuan, but this has not significantly impacted its operations [6]. - An audit by Ernst & Young revealed no hidden large debts or misuse of funds within Green Valley, indicating a stable financial condition [6][7]. - The acquisition is not expected to have a significant impact on Fosun Pharma's consolidated profits in the short term, as Green Valley's assets and liabilities represent a small fraction of Fosun's total [7].

Core Viewpoint - Fosun Pharma is investing 14.12 billion yuan in Green Valley Pharmaceutical to acquire a controlling stake, aiming to integrate the Alzheimer's drug, Manluotena Capsules, into its innovative drug pipeline, enhancing its position in the Alzheimer's disease sector [2][7]. Group 1: Investment Details - The investment consists of acquiring existing equity (1.43 billion yuan) and subscribing to new registered capital (12.69 billion yuan) [3][8]. - The payment for the new registered capital will be made in installments, with the first payment of 6.35 billion yuan due on the closing date, and the remaining 6.35 billion yuan to be paid within three years based on the target company's R&D progress [4][8]. Group 2: Clinical Progress and Regulatory Issues - Manluotena Capsules received conditional approval from the National Medical Products Administration (NMPA) in November 2019 for treating mild to moderate Alzheimer's disease, becoming the first approved drug for this indication since 2002 [2][7]. - The drug has faced efficacy controversies, with criticisms regarding the validity of its research and changing mechanisms of action [2][7]. - Green Valley Pharmaceutical submitted a supplementary application to extend the drug's registration before its five-year validity expires in 2024, but the NMPA did not approve it due to incomplete post-marketing confirmatory clinical studies [2][7]. Group 3: Risk Management and Future Plans - Fosun Pharma conducted due diligence covering clinical, regulatory, patent, production, commercialization, financial, legal, human resources, and investment aspects of Green Valley and its main product [3][8]. - The company has implemented risk control measures, including the pledge of 10% of the acquired equity by the founder's entity to secure potential losses [4][8]. - The clinical trial design for the confirmatory study has been revised, extending the double-blind treatment period from 36 weeks to 48 weeks and increasing the sample size from 1,312 to 1,950 participants, with approval from the NMPA [9]. - 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 a summary report to the NMPA in early 2029 [10].

Core Viewpoint - GV-971 (also known as "Jiuyiqi"), an Alzheimer's disease drug, is facing challenges in its clinical validation and regulatory approval process, with significant market reactions following the announcement of its acquisition by Fosun Pharma [1][3]. Group 1: Clinical Research and Approval Status - GV-971's confirmatory clinical research plan has been approved by the drug review center, with 580 patients enrolled so far, and the acquisition funds will be used to advance clinical trials [1][3]. - The drug received conditional approval in November 2019 but failed to complete the necessary post-marketing confirmatory clinical studies, leading to its inability to achieve full approval by the expiration of its registration certificate in November 2024 [3][10]. - The drug's post-marketing confirmatory clinical trial, which began in October 2022, has faced delays, with only 580 out of the targeted 1,312 patients enrolled as of December 2023, indicating significant progress issues [10][11]. Group 2: Market Reaction and Investor Sentiment - Following the announcement of the acquisition plan on December 15, Fosun Pharma's A-shares fell over 4% and H-shares dropped more than 5% by December 16, reflecting investor skepticism regarding the drug's future [1][3]. - The trading volume and value on December 16 were the highest in a week, indicating heightened market activity and concern [1]. Group 3: Research Design and Methodology - The real-world study required for long-term safety and efficacy has been submitted, but the duration of the data collected is only 48 weeks, half of the originally designed 96 weeks, which raises concerns about its adequacy [7][9]. - The confirmatory clinical trial design has been updated to include 1,950 patients and extend the double-blind treatment period from 36 weeks to 48 weeks, aligning it more closely with international standards for Alzheimer's drug trials [11][12].

【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].