Bio-Thera Solutions (688177.SH): Aishali/Xishali (Ustekinumab Injection) has obtained a drug registration certificate.

Bio-Thera Solutions (688177.SH) announced that the company recently received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA) regarding the approval of the monoclonal antibody injection of ustekinumab (BAT2206, trade name: Aishali) and ustekinumab intravenous infusion (BAT2206, trade name: Xishali). BAT2206 is a ustekinumab monoclonal antibody injection developed by Bio-Thera Solutions based on the biosimilar drug development guidelines of the NMPA, the Food and Drug Administration (FDA) of the United States, and the European Medicines Agency (EMA). Ustekinumab is a fully human monoclonal antibody that targets the p40 subunit shared by interleukin-12 and interleukin-23. IL-12 and IL-23 are naturally occurring cytokines that play a role in inflammation and immune response processes. Ustekinumab binds specifically with high affinity to the p40 subunit, blocking its interaction with cell surface receptors, thus disrupting IL-12 and IL-23-mediated signaling and cytokine effects. As of the date of this announcement, BAT2206 has been approved for marketing by the FDA and EMA, with the trade name Starajemza in the United States and Usymro in Europe. Commercialization authorization for BAT2206 has already covered 71 countries and regions worldwide.