Just now, NMPA released the drug approval certificate delivery information on January 2, 2024.This batch has approved 79 application numbers, of which 11 are for consistency evaluation., including the following approved varieties:Yabang Pharmaceutical Co., Ltd., Famotidine Injection
Warrant Pharmaceutical, Ornidazole Injection
Anhui Weiman Pharmaceut Ical Co., Ltd., Cefotaxime Sodium for Injection
This time, 49 marketing application acceptance numbers have been approved, involving more than 30 varieties., such as:SUNCADIAAbiraterone Acetate Tablets (Ⅱ); Jilin Sihuan Pharmaceutical Co., Ltd.Sacubitril Valsartan Sodium Tablets; Renheyikang Group'sNicorandil for Injection; Yichang Humanwell Pharmaceutical Co.,Ltd.Acetaminophen and Oxycodone Tablets; CHIATAI TIANQINGEverolimus Tablets; BrightGene Pharmaceutical Co.,Ltd.Oseltamivir Phosphate Granules; Shijiazhuang No.4 Pharmaceutical Co.,Ltd.Nifedipine Sustained-Release Tablets (Ⅱ)。In addition,BeOne Medicines' Tislelizumab Injection Receives Approval for New IndicationThe speculated indication is:For the treatment of first-line unresectable or metastatic hepatocellular carcinoma.Shanghai Junshi Biosciences' Toripalimab Injection Receives Approval for New Indication;Jiangsu Kanion Pharmaceutical Co., Ltd.'s Jichuan Decoction Granules and Shenwei Pharmaceutical's Yiguan Decoction Granules, two new traditional Chinese medicine drugs, have been approved.Sanofi (China)'s Rosuvastatin Ezetimibe Tablets (I) Approved for Marketing，For the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients.Rosuvastatin Ezetimibe Tablets (I) is the first single-tablet combination formulation of rosuvastatin and ezetimibe approved for marketing in China.Roche's Faricimab Injection Approved for Marketing in ChinaFor the treatment of diabetic macular edema (DME).Nirsevimab, a long-acting monoclonal antibody jointly developed by Sanofi and AstraZeneca, has been approved for marketing.，For the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in newborns and infants.Nirsevimab is the first and only approved preventive measure in China to protect the broad population of infants against RSV infection, covering healthy full-term infants, premature infants, and those susceptible to severe RSV infections due to specific health conditions.Welcome to add WeChat and join the Approval Family.For communication only, unrelated to official sources.
