亿帆医药股份有限公司关于获得药品注册证书的公告

Core Viewpoint - Yifan Pharmaceutical has received the drug registration certificate for Hydrochloride Etizolam Injection, marking its entry into the controlled substance market and enhancing its product portfolio [1][4]. Group 1: Drug Registration Information - The drug name is Hydrochloride Etizolam Injection, classified as a chemical drug of category 3 [2][3]. - The approval conclusion states that the product meets the requirements for drug registration according to Chinese regulations [1][2]. - The drug registration certificate was issued on April 8, 2025, with a validity period until March 31, 2030 [3]. Group 2: Product Overview - Hydrochloride Etizolam Injection is indicated for pain relief, particularly for cancer pain and postoperative pain [2]. - The company submitted the drug application in June 2023, received acceptance in July 2023, and obtained the research approval for controlled substances in September 2023 [2]. - The product is the first of its kind in China to pass the consistency evaluation for generic drugs [2]. Group 3: Market and Financial Impact - The domestic sales of Hydrochloride Etizolam Injection reached 128 million yuan in 2023 [2]. - The company has invested approximately 10.02 million yuan in the research and development of this product [2]. - The approval of this product is expected to positively impact the company's performance and enhance its competitiveness in the pharmaceutical sector [4].