Baoji Pharmaceutical-B Receives NMPA Acceptance for New Drug Application of Injectable KJ103

Baoji Pharmaceutical-B (HKEX: 02659) announced that on June 4, 2026, the New Drug Application (NDA) for its self-developed injectable KJ103 was accepted for review by China's National Medical Products Administration (NMPA).

The application is for the use of KJ103 in desensitization therapy for highly sensitized kidney transplant patients, to effectively clear pre-existing HLA antibodies and prevent hyperacute rejection. The application was also approved for inclusion in a priority review program by the NMPA's Center for Drug Evaluation on May 20, 2026.

KJ103 is a first-in-class, low-immunogenicity innovative recombinant immunoglobulin G (IgG) degrading enzyme, intended for treating various immune diseases and conditions driven by pathological IgG antibody activity. It works by binding to the CH2 region of the IgG constant domain and cleaving IgG at a specific site in the hinge region between CH1 and CH2. This mechanism is well-defined and carries a low immunogenicity risk, allowing for the safe, efficient, rapid, and specific degradation of human IgG to quickly clear pre-existing HLA antibodies in highly sensitized transplant patients.

This specific indication was granted Breakthrough Therapy Designation by the NMPA's Center for Drug Evaluation on November 19, 2024. KJ103 has now completed the primary trial follow-up for all participants in its Phase III clinical trial, with the completed studies supporting this marketing application.

Clinical data show that KJ103 administration can rapidly and effectively reduce or eliminate HLA antibodies, achieving a 100% desensitization treatment success rate and a 100% kidney transplant success rate prior to transplantation, with a graft survival rate of 100% beyond three months.

The company is also actively exploring the therapeutic potential of KJ103 in other antibody-mediated acute autoimmune diseases. For instance, KJ103 completed a Phase II clinical trial for anti-glomerular basement membrane disease (anti-GBM disease) in October 2025, and initiated a Phase II clinical trial for Guillain-Barré syndrome (GBS) in November 2025.

According to publicly available data, compared to other approved IgG degrading enzymes on the market, KJ103 demonstrates lower percentages and titers of pre-existing antibodies, indicating its potential to offer a safer and more effective treatment option for patients with acute autoimmune conditions.