亿帆医药: 关于全资子公司收到药品注册受理通知书的公告

Core Viewpoint - Yifan Pharmaceutical's subsidiary has received a notice of acceptance for the registration application of melatonin granules for domestic production, marking a significant step in the company's product development and market entry strategy [1][2]. Group 1: Application Registration Details - The application for the drug registration is for melatonin granules, with the acceptance number CYHS2502833 [1]. - The drug is classified as a Class 4 chemical drug and is intended to improve sleep difficulties in children aged 6-15 with neurodevelopmental disorders [1]. - The application was submitted on July 29, 2025, and was accepted on August 5, 2025 [1]. Group 2: Market Context and Competition - As of the report date, the only approved melatonin granules in China are original imported products, with no other companies having submitted applications [1]. - Yifan Pharmaceutical is the first to apply for a generic version of melatonin granules in China [1]. - According to IQVIA data, the global sales of melatonin granules were approximately $20.09 million in 2024 [2]. Group 3: Research and Development Investment - The company has invested approximately 3 million in the research and development of the melatonin granules project [2].