BAO PHARMA-B (02659.HK): NMPA Approves IND Application for BJ045 Injection

NewTimeSpace News: On 20 October 2026, Shanghai Bao Pharmaceuticals Co., Ltd. (the "Company") voluntarily announced that on 19 October 2026 the investigational new drug (IND) application for BJ045 injection, a subcutaneously administered anti-enzyme-degradation anti-CD20 monoclonal antibody independently developed by the Company, was approved by the National Medical Products Administration of the People's Republic of China, permitting clinical trials in China.

The announcement disclosed that BJ045 is a subcutaneously administered anti-CD20 antibody resistant to degradation by IgG-degrading enzymes, with potential for combination with IgG-degrading enzymes such as the Company's KJ103 in treating moderate-to-severe autoimmune diseases. BJ045 is a differentially designed CD20 monoclonal antibody which, through the Company's directed hinge engineering platform and defucosylation modification and by specifically binding to the CD20 type II epitope, retains both specific CD20 type II epitope binding and Fc effector function while resisting enzymatic cleavage; it significantly enhances affinity for Fc receptors on effector cells and boosts ADCC activity, supporting deep depletion of CD20-positive B cells in peripheral blood and tissues.

The Company stated that antibody therapies targeting B cells such as CD20 are typically used after acute flares of antibody-mediated autoimmune diseases or during organ transplantation, but such therapies mainly suppress the production of new antibodies without eliminating pathological antibodies already present in patients, and often fail to effectively slow disease progression or prevent further deterioration; when combined with IgG-degrading enzymes such as KJ103, BJ045 can deplete B cells that produce existing IgG antibodies and rapidly lower IgG levels, producing a synergistic therapeutic effect. In addition, leveraging the Company's competitive advantage in subcutaneously administered candidates, BJ045's subcutaneous formulation (containing recombinant human hyaluronidase) is expected to improve the treatment experience and patient compliance. The Company cautioned that, given the many unpredictable factors in clinical trials, it cannot guarantee the eventual successful development or commercialisation of BJ045.