阿尔茨海默病“神药”突然被爆停产！多地断货，线上药房现5000元/盒“天价”

Core Viewpoint - The production of Manzoutan capsules, used for treating Alzheimer's disease, has been halted due to the expiration of its drug registration certificate, with the company awaiting approval from the drug regulatory authority [1][8]. Company Summary - Green Valley Pharmaceutical Technology has confirmed the closure of its office and production areas related to Manzoutan capsules, citing the expiration of the drug registration certificate and the ongoing wait for regulatory approval [1][8]. - The company previously acknowledged the difficulties patients faced in obtaining the medication and expressed regret over the potential impact of drug interruptions on patients' conditions [8]. Market Summary - The market price of Manzoutan capsules has surged approximately 40% in recent months, with prices on e-commerce platforms ranging from 428 yuan to 534.5 yuan per box, and some pharmacies listing prices as high as 5000 yuan per box [4]. - Reports indicate that many patients are struggling to find the medication, with numerous complaints about stock shortages and price hikes on social media [5][4]. Regulatory Summary - The approval status of Manzoutan capsules is currently pending, having entered the review queue on October 25, 2024. The situation of halting production due to expired licenses is considered rare in the industry [8][9]. - Manzoutan capsules were conditionally approved for market entry in China in November 2019, marking it as the first new drug for Alzheimer's disease approved globally since 2003 [8][9]. Clinical Summary - Concerns regarding the efficacy and safety of Manzoutan capsules persist, as the drug was approved under conditions requiring further research on its pharmacological mechanisms and long-term safety [9]. - The three-phase clinical trial for Manzoutan lasted only 36 weeks, which is deemed insufficient for a chronic degenerative disease like Alzheimer's, typically requiring longer observation periods to confirm sustained cognitive improvement [9].