On June 27th, Globenewswire reported that HJB Pharmaceutica-B (02142.HK) has made progress in developing bartolizumab (HBM9161). Since the release of this announcement, the company has continued to actively communicate with the National Medical Products Administration ("NMPA") of China regarding the biologics license application ("BLA") of bartolizumab (HBM9161) and the subsequent related interactions and processes. The company hereby announces that it has submitted the BLA for bartolizumab (HBM9161) to the NMPA again on June 26, 2024.
According to the disclosure, bartolizumab is a fully human monoclonal antibody that selectively binds and inhibits neonatal Fc receptor (FcRn). FcRn plays a key role in preventing the degradation of IgG antibodies. High levels of pathogenic IgG antibodies can induce various autoimmune diseases. As one of the most advanced FcRn inhibitors in clinical development in Greater China, bartolizumab has the potential to become a breakthrough therapy for the treatment of various autoimmune diseases in this region.