Baoji Pharmaceutical-B (02659): BJ045 injection clinical trial application approved by China National Drug Administration

Zhitong Finance App News, Baoji Pharmaceutical-B (02659) issued an announcement. On October 19, 2026, the clinical trial application (IND) for the BJ045 injection (an anti-enzymatic anti-CD20 monoclonal antibody administered subcutaneously, collectively known as BJ045) was approved by the China Drug Administration of the People's Republic of China and approved to conduct clinical trials in China.

bj045 is an anti-CD20 antibody administered subcutaneously that is degraded by IgG degrading enzymes, and has the potential to be used in combination with IgG degrading enzymes (such as our KJ103) to treat moderate to severe autoimmune diseases. BJ045 is a CD20 monoclonal antibody with a differentiated design. Through our powerful targeted hinge modification platform and fucoidation modification and specific binding to CD20 type II epitopes, BJ045 maintains specific binding to CD20 type II epitope function and FC effect function while having anti-enzymatic function, which can significantly improve its affinity with effector cell Fc receptors and enhance ADCC activity, which is conducive to deep removal of CD20 positive B cells in peripheral blood and tissues.

Antibody therapy targeting B cells (such as CD20) is commonly used after an attack of antibody-mediated acute autoimmune disease or during organ transplantation. However, these treatments are often not effective in slowing the progression of the disease or preventing further worsening of the disease, because they mainly inhibit the production of new antibodies, but do not eliminate the pathological antibodies already present in the patient's body. In contrast, when used in combination with IgG degrading enzymes (such as KJ103), BJ045 produces a synergistic therapeutic effect by consuming B cells that produce existing IgG antibodies and rapidly reducing IgG levels. Furthermore, with our competitive advantage in drug candidates for subcutaneous administration, BJ045's subcutaneous preparation (containing recombinant human hyaluronidase) is expected to improve treatment experience and patient compliance. These are the main challenges in the current anti-CD20 antibody market.