Xin Lang Cai Jing·2025-12-23 12:43Core 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].