BAO PHARMA-B (02659) has announced the completion of primary trial follow-up for all participants in the Phase III clinical study of KJ103 as a desensitization therapy for highly sensitized patients awaiting kidney transplantation in China. The follow-up period concluded on March 20, 2026. The company plans to submit a New Drug Application to the National Medical Products Administration promptly.
KJ103 is a first-in-class, low-immunogenicity innovative recombinant immunoglobulin G (IgG) degrading enzyme, developed for treating various immune-mediated diseases and conditions driven by pathological IgG antibodies. In August 2025, the company initiated the Phase III clinical trial (CTR20252973) to evaluate KJ103 for desensitization in highly sensitized renal transplant recipients, with the goal of effectively clearing pre-existing HLA antibodies and preventing hyperacute rejection.
In November 2024, KJ103 received Breakthrough Therapy Designation from the National Medical Products Administration for this specific indication.
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