Jing Ji Guan Cha Wang·2025-12-17 04:33Core Viewpoint - A controversial Alzheimer's drug, known as "971," has regained the possibility of being marketed after a significant investment by Fosun Pharma, despite ongoing skepticism regarding its efficacy [2][3]. Company Summary - Fosun Pharma announced plans to invest approximately 1.412 billion yuan to acquire a 51% stake in Green Valley (Shanghai) Pharmaceutical Technology Co., known for the drug "971" [3]. - The drug was conditionally approved in China in 2019, marking the first Alzheimer's drug to enter the market in 17 years, with sales of over 2 million boxes expected in 2024 [3][13]. - Due to the failure to complete post-marketing confirmatory clinical trials, the National Medical Products Administration (NMPA) did not approve the drug's reapplication in 2025, leading to its suspension [3][5]. - Fosun Pharma's management expressed confidence in the drug's efficacy and plans to conduct the necessary clinical trials to seek reapproval by 2029, with peak sales projected to reach around 4 billion yuan by 2035 [3][5][8]. Clinical Trial and Regulatory Summary - The company aims to complete the post-marketing confirmatory clinical trials, which are estimated to cost around 685 million yuan, and will involve over 1,900 patients [6][7]. - The trials will assess cognitive and functional outcomes in accordance with international standards, with completion expected by the end of 2028 [7][10]. - Fosun Pharma has already discussed a new plan with the NMPA to meet drug registration requirements [6][8]. Market Reaction and Financial Impact - The market reacted negatively to the acquisition announcement, with Fosun Pharma's stock dropping by 4.22% in A-shares and 5.81% in Hong Kong shares on December 16 [3]. - The estimated target population for the drug is around 3.56 million, with a projected market penetration rate of 22% [8][10]. - If the drug is approved in the first half of 2029 and enters insurance coverage by 2030, peak sales could reach approximately 4 billion yuan; if delayed, sales could still exceed 1 billion yuan in 2030 [8][10]. Controversy and Efficacy Concerns - The drug's efficacy has been heavily criticized, with notable academic figures questioning its mechanism and clinical trial data [9][10]. - Despite the controversies, there is a significant demand for the drug, with prices in the market reportedly reaching 1,600 to 2,400 yuan, significantly higher than its previous insurance price [11][12]. - The ongoing debate about the drug's effectiveness continues to influence investor sentiment and market dynamics [9][10].