Bio-Thera Solutions (688177.SH): Ashuli (golimumab injection) receives drug registration certificate
Bio-Thera Solutions (688177.SH) announced that the company recently received the Drug Registration Certificate for golimumab injection (BAT2506, trade name: Ashuli) approved and issued by the National Medical Products Administration (NMPA).
Bio-Thera Solutions (688177.SH) announced that the company recently received the Drug Registration Certificate approved and issued by the National Medical Products Administration (NMPA) for golimumab injection (BAT2506, trade name: Ashuli).
It is reported that BAT2506 is a golimumab biosimilar developed by the company in accordance with the relevant biosimilar guidelines of the NMPA, the U.S. Food and Drug Administration, and the European Medicines Agency. Golimumab is an antibody targeting TNF- that can specifically bind with high affinity to both soluble and transmembrane human TNF-, blocking the binding of TNF- to its receptor TNFR, thereby inhibiting TNF- activity. Ashuli is the first golimumab biosimilar in China, and its approval for marketing will help enhance the market competitiveness of the company's products and have a positive effect on the company's business development.
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