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拟控股收购绿谷医药,复星医药收监管函
Huan Qiu Wang· 2025-12-18 09:50
Core Viewpoint - The Shanghai Stock Exchange issued a regulatory work letter regarding Fosun Pharma's investment in Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd., which involves a listed company. The specific content of the regulatory letter has not been disclosed [1]. Group 1: Investment Details - Fosun Pharma announced that its subsidiary, Fosun Pharma Industry, signed an investment agreement with Green Valley and its existing shareholders, planning to invest approximately RMB 1.412 billion to acquire a controlling stake in Green Valley [2][3]. - Following the acquisition, Green Valley will become a subsidiary of Fosun Pharma, and its core drug, Man-nitol Sodium Capsules, will be included in Fosun Pharma's innovative drug pipeline, primarily used for treating mild to moderate Alzheimer's disease [3]. Group 2: Drug Information - The core product of Green Valley is Man-nitol Sodium Capsules, known in the industry as "971" or "Jiuyiqi." It is the first new drug approved globally for treating Alzheimer's disease since 2003 [3]. - The drug received conditional approval from the National Medical Products Administration (NMPA) in November 2019 for use in mild to moderate Alzheimer's disease, filling a 17-year gap in new drug approvals in this field [3]. - Due to the conditional approval, the NMPA requires Green Valley to conduct ongoing pharmacological mechanism studies and long-term safety and efficacy research, as well as to submit relevant trial data on time [3]. Group 3: Regulatory and Market Challenges - In May 2025, there were reports of difficulties in purchasing "Jiuyiqi" at hospitals, and related positions in the product line were reported to be suspended. Analysts suggest this situation arose because the drug registration certificate for Man-nitol Sodium had expired, and the company is awaiting the NMPA's approval results [3]. - Green Valley is expected to submit materials to the NMPA for a new drug license in May 2024, with the regulatory body requesting supplementary materials in October of the same year [3]. Group 4: Company Commitment - Fosun Pharma stated that it will fully support the post-marketing confirmatory clinical research of Man-nitol Sodium Capsules to expedite the approval process [4].