金陵药业股份有限公司关于分公司收到药物临床试验批准通知书的公告

Core Viewpoint - Jinling Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of Orelagol tablets, which are intended for the treatment of moderate to severe pain associated with endometriosis [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for Orelagol tablets was accepted on June 20, 2025, and has been approved to proceed with Phase III clinical research [2]. - The product is classified as a Class 3 chemical drug and is available in dosages of 150mg and 200mg [1][3]. - Orelagol is a GnRH antagonist used primarily for treating moderate to severe pain related to endometriosis [3]. Group 2: Regulatory Compliance - The application for the clinical trial meets the requirements set forth by the Drug Administration Law of the People's Republic of China [2]. - The approval signifies compliance with the relevant drug registration regulations [2]. Group 3: Product Information - Orelagol tablets are included in the second batch of encouraged generic drug lists in China [3].