绿谷“九期一”停产因未补齐三期临床数据？药物主要发明人回应：继续做！

Core Viewpoint - The production of the Alzheimer's drug "Jiuyiqi" by Green Valley Pharmaceutical has been halted due to the expiration of its license, prompting concerns among patients about when it will resume production. The drug is required to supplement its Phase III clinical data, which has been deemed insufficient [1][2]. Group 1: Clinical Trial and Regulatory Issues - The initial Phase III clinical trial for "Jiuyiqi" was conducted over a period of only 9 months, which has raised significant concerns regarding its adequacy compared to international standards that typically require two parallel trials [1][2]. - The drug was conditionally approved in November 2019, with the understanding that additional data, including a long-term carcinogenicity study in rats, would be submitted within three months. This data has since been provided, showing no carcinogenic risk [2]. - Due to the COVID-19 pandemic, the originally planned global clinical trials were reduced to a smaller scale conducted domestically, which has led to questions about the rigor of the trial design [3]. Group 2: Market Context and Competitive Landscape - Since the launch of "Jiuyiqi," it has been included in the medical insurance system, significantly reducing the monthly treatment cost from over 1500 RMB to under 300 RMB [4]. - In the past year, new Alzheimer's treatments such as Lecanemab and Donanemab have been approved, but they come with high annual treatment costs of around 200,000 RMB and are not yet covered by insurance [4]. - There is a strong call within the industry for domestic manufacturers to continue investing in innovative Alzheimer's drug development to address the substantial unmet clinical needs, as existing treatments are either expensive or ineffective for late-stage diseases [4].