Xin Lang Cai Jing·2025-12-23 12:41Core 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].