Announcement #Yunnan Baiyao: Compound sulfamethoxazole tablets passed the consistency evaluation

Shanghai Securities News China Securities Network News (reporter Han Yuanfei) Yunnan Baiyao announced at noon on December 31, recently, the company received the State Drug Administration approved the issuance of compound sulfamethoxazole tablets "Drug Supplement Application Approval Notice", the product through the generic drug quality and efficacy consistency evaluation.

Compound sulfamethoxazole tablets are a combination formulation of sulfamethoxazole (SMZ) and trimethoprim (TMP), originally developed by Sun Pharm INDs and marketed in the United States in 1973 with FDA approval. The drug is a sulfonamide antibacterial drug, mainly used to prevent or treat infection caused by sensitive strains, and is a national essential drug, a class A drug in the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2020). Yunnan Baiyao has invested about RMB 7.1 million in research and development costs for the consistency evaluation of compound sulfamethoxazole tablets.

Yunnan Baiyao said that the compound sulfamethoxazole tablets passed the consistency evaluation of the quality and efficacy of generic drugs, which is the embodiment of the company's comprehensive strength in research and development capabilities, production and quality management system, and is also the recognition of the above comprehensive capabilities and product quality by the national drug regulatory authorities. At the same time, it has also accumulated valuable experience for the company's subsequent compliance evaluation of other generic drugs.