浙江华海药业股份有限公司关于制剂产品西格列汀二甲双胍片获得美国FDA暂时批准文号的公告

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received temporary approval from the U.S. FDA for its generic drug, Sitagliptin Metformin Tablets, which is a significant step towards entering the U.S. market for diabetes treatment [1][2]. Group 1: Drug Approval Details - The U.S. FDA has granted temporary approval for the ANDA (Abbreviated New Drug Application) of Sitagliptin Metformin Tablets, indicating that the drug has met all review requirements but is still under patent protection [1][2]. - The drug is primarily used for the treatment of type 2 diabetes and was originally developed by MSD SUB MERCK, first launched in the U.S. in March 2007 [1][4]. - The estimated sales for this drug in the U.S. market for 2024 is approximately $1.1 billion [1]. Group 2: Financial and Strategic Implications - The company has invested around 11.4 million RMB in the research and development of Sitagliptin Metformin Tablets for the U.S. market [2]. - The temporary approval is expected to enhance the company's product supply chain, diversify its product portfolio, and improve market competitiveness, positively impacting its expansion into the U.S. market [2].