Merck & Co., Inc. (MRK.US) orally administered new drug "Enlicizumab Tablets" have filed for market approval in China.

On July 9th, the official website of the China Drug Evaluation (CDE) showed that the market application for Merck & Co., Inc.'s (MRK.US) Class 1 new drug "Enlicitide tablets" has been accepted. Merck & Co., Inc. previously stated in a press release that Enlicitide is expected to become the first approved oral PCSK9 inhibitor. Enlicitide tablets (Enlicitide, research code: MK-0616) is a PCSK9 oral cyclic peptide inhibitor developed by Merck & Co., Inc. Its design goal is to provide LDL-C lowering effects comparable to PCSK9 monoclonal antibodies, while maintaining safety characteristics similar to placebo. The efficacy and safety of Enlicitide are currently being evaluated through the comprehensive CORALreef clinical trial program, including CORALreefOutcomes, CORALreefHeFH, CORALreefLipids, CORALreefAddOn, etc. Insight database shows that there are currently 7 PCSK9 targeted drugs approved domestically, including Alirocumab, Evolocumab, Inclisiran sodium, Bococizumab, Isunakinra, Angorixumab, and Regacicumab. Among them, Inclisiran sodium is different from the other 6 as it is a small interfering RNA (siRNA) drug, making it more convenient for dosing as it can be administered every six months after the first two doses. In addition, Shenzhen Salubris Pharmaceuticals' Tacacicumab, EVEREST MED's Ledacizumab, and Merck & Co., Inc.'s Enlicitide are all in the market approval stage.