Zhejiang Jiuzhou Pharmaceutical (603456.SH): The US FDA has approved the listing permit for the slow-release tablets of sitagliptin and metformin sustained release tablets.

Zhejiang Jiuzhou Pharmaceutical (603456.SH) announced that its controlling subsidiary Zhejiang Jiuzhou Biopharmaceutical Co., Ltd. ("Jiuzhou Biopharma") has received temporary approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Sitagliptin Metformin Extended-Release Tablets. Temporary approval means that the FDA has completed all evaluation requirements for generic drugs, but approval is given in a provisional form due to patent or exclusivity rights not yet expiring. Sitagliptin Metformin Extended-Release Tablets are primarily used for type 2 diabetes patients who do not have their blood sugar well controlled with either Metformin alone or a combination of both drugs. The original brand drug for Sitagliptin Metformin Extended-Release Tablets is JanumetXR, developed by Merck & Co., Inc., and was launched in the United States in February 2012. Currently, the drug is still under patent protection in the U.S., with only the original brand product being available on the market. According to publicly available data, the sales of this drug in the U.S. market are approximately $1.1 billion in 2024.