石家庄以岭药业股份有限公司关于收到化学原料药上市申请批准通知书的公告

Core Viewpoint - Shijiazhuang Yiling Pharmaceutical Co., Ltd. has received approval for the listing application of Memantine Hydrochloride, a chemical raw material drug, which is expected to enhance the company's product line and market share in the Alzheimer's treatment sector [1][2]. Group 1: Approval Notification - The approval notification was issued by the National Medical Products Administration for the chemical raw material drug Memantine Hydrochloride, submitted by the company's wholly-owned subsidiary, Hengtai Wanyuan Pharmaceutical Co., Ltd. [1] - The registration number for the drug is Y20240000483, confirming that it meets the requirements for drug registration under Chinese law [1]. Group 2: Drug Overview - Memantine Hydrochloride is a non-competitive NMDA receptor antagonist used to treat moderate to severe Alzheimer's disease, blocking neuronal damage caused by elevated glutamate levels [2]. - According to the 2024 China Alzheimer's Disease Report, there are approximately 16.9 million dementia patients in China, with a prevalence rate of about 1.19% [2]. - The anti-dementia market in China is valued at 1.56 billion yuan, with Memantine being a first-line treatment drug holding a market share of 22% [2]. - The market capacity for Memantine Hydrochloride in China is expected to reach 340 million yuan by 2025, with a year-on-year growth of 11% [2]. Group 3: Impact on the Company - The approval of Memantine Hydrochloride allows the company to sell the drug in the domestic market, enriching its product line and expanding its business scope [3]. - Currently, the approval is not expected to have a significant impact on the company's immediate operating performance [3].