Shanghai Bao Pharma completes Phase III trial follow-up for first-in-class KJ103 in kidney-transplant desensitisation

Bulletin Express03-25

Shanghai Bao Pharmaceuticals Co., Ltd. (Shanghai Bao Pharma) announced the completion of primary follow-up for all patients enrolled in its Phase III clinical study (CTR20252973) of KJ103 as a desensitisation therapy for highly sensitised kidney-transplant candidates in mainland China. The trial, which began in August 2025, assessed KJ103’s ability to clear pre-existing human leukocyte antigen antibodies and reduce the risk of hyper-acute rejection.

KJ103 is described as a globally first-in-class, low-immunogenicity recombinant IgG-degrading enzyme targeting immune-mediated diseases driven by pathogenic IgG antibodies. The programme received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) in November 2024.

With the clinical follow-up phase now concluded as of 20 March 2026, the company intends to file a new drug application with the NMPA “as soon as practicable.” Management cautioned that development and commercialisation timelines remain subject to regulatory evaluation and other uncertainties, and advised shareholders and potential investors to exercise caution when dealing in the company’s shares.

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