Shang Hai Zheng Quan Bao·2025-12-22 17:56Core Viewpoint - Shanghai Fosun Pharmaceutical Group Co., Ltd. is responding to regulatory inquiries regarding its investment in Green Valley Pharmaceutical, particularly focusing on the uncertainties surrounding the commercialization and clinical trials of its main product, Ganluo Sodium Capsules, which is aimed at treating Alzheimer's disease. Group 1: Investment and Financial Aspects - The company plans to invest a total of 14.12 billion yuan to gain controlling interest in the target company [3] - The acquisition is expected to result in significant goodwill, which may be subject to impairment risks if the clinical trials do not meet expectations [3][4] - As of September 30, 2025, the target company reported total assets of 806 million yuan and liabilities of 795 million yuan, indicating a very low equity position [25] Group 2: Product Development and Clinical Trials - Ganluo Sodium Capsules received conditional approval from the National Medical Products Administration (NMPA) in November 2019 for treating mild to moderate Alzheimer's disease [6] - The product's registration certificate is set to expire in November 2024, and the company must complete ongoing post-marketing confirmatory clinical trials to resume commercialization [24] - The ongoing confirmatory clinical trial aims to enroll 1,950 patients, with 580 already enrolled as of December 15, 2025, and is expected to complete by the end of 2027 [19] Group 3: Regulatory Challenges and Market Competition - The NMPA did not approve the extension of the product's registration due to the ongoing clinical trials, which raises uncertainties about the product's future [10] - The market for Alzheimer's treatments is becoming increasingly competitive, with multiple products either already on the market or in development, which could impact the sales of Ganluo Sodium Capsules [3][4] - The company has implemented various risk control measures to address potential issues related to the product's efficacy and safety during the clinical trial process [17] Group 4: Compliance and Legal Issues - The target company faced administrative penalties for improper sales practices, which were confirmed during due diligence, but these penalties have not significantly impacted its operations [29][30] - The company has established a compliance framework to manage marketing activities and ensure adherence to regulatory standards following the acquisition [30]