北京福元医药股份有限公司关于酮洛芬凝胶贴膏获得药物临床试验批准通知书的公告

Core Viewpoint - Beijing Fuyuan Pharmaceutical Co., Ltd. has received approval for clinical trials of Ketoprofen Gel Patch from the National Medical Products Administration (NMPA) [1][2] Group 1: Clinical Trial Approval - The drug name is Ketoprofen Gel Patch, with the notification number 2025LP03166, and it is classified as a Class 3 chemical drug [2][3] - The approved indications include pain relief and anti-inflammatory treatment for conditions such as osteoarthritis, shoulder periarthritis, tendonitis, tennis elbow, muscle pain, and post-injury swelling and pain [1][3] Group 2: R&D Investment - Fuyuan Pharmaceutical has invested approximately RMB 3.9676 million (about 0.4 million USD) in the research and development of the Ketoprofen Gel Patch [3] Group 3: Market Situation - As of 2024, the sales revenue of Ketoprofen Gel Patch in China is approximately RMB 49.58 million (about 4.96 million USD), with significant sales in urban public hospitals and county-level public hospitals [6] - In the first half of 2025, the sales revenue increased to approximately RMB 76.44 million (about 7.64 million USD) [7] Group 4: Regulatory Pathway - The clinical trial application has been approved, and the product must undergo clinical research and receive further approval from the NMPA before it can be marketed [7]