The marketing authorization application for dapagliflozin tablets from Beijing Saier Biological Pharmaceutical, a subsidiary of Beijing Saisheng Pharmaceutical, has been accepted by the National Medical Products Administration. The drug, available in 5 mg and 10 mg strengths, is an SGLT-2 inhibitor that lowers blood glucose by inhibiting renal tubular glucose reabsorption. It entered the Chinese market in 2017 and is taken orally once daily. The company stated that the product has entered the registration review stage and will not have a significant impact on performance in the near term, but if approved smoothly, it will further enrich the product pipeline. It also reminded investors that there is uncertainty in drug registration approval.
Beijing Science Sun Pharmaceutical Co LtdMarketing authorization application accepted for dapagliflozin tablets, a regulatory milestone that could enrich product pipeline if approved.