Shanghai Bao Pharmaceuticals Co., Ltd. (BAO PHARMA-B, 02659) announced that China’s National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for KJ103 for Injection on 4 June 2026 and placed the product on its priority review and approval track on 20 May 2026.

KJ103 profile • First-in-class, low-immunogenic recombinant IgG-degrading enzyme targeting the hinge region between CH1 and CH2 of human IgG. • Designed to rapidly eliminate pre-existing HLA antibodies in highly sensitized kidney-transplant candidates, thereby preventing hyperacute rejection. • Received Breakthrough Therapy Designation from the NMPA’s Center for Drug Evaluation (CDE) on 19 November 2024.

Clinical data • Phase III trial has completed primary follow-up for all participants. • Reported 100% success in pre-transplant desensitization and 100% kidney-transplant success; graft survival exceeded three months in all recipients. • Comparative public data indicate lower incidence and titre of pre-existing antibodies versus approved IgG-degrading enzymes, suggesting a favourable safety profile.

Pipeline expansion • Completed Phase II study in anti-glomerular basement membrane (anti-GBM) disease in October 2025. • Initiated Phase II trial in Guillain-Barré syndrome (GBS) in November 2025, underscoring broader autoimmune potential.

Market backdrop Chronic kidney disease affects an estimated 13.40% of the global population, with 4.90 million–7.10 million patients requiring kidney replacement therapy. Roughly 40% of wait-listed transplant candidates carry anti-HLA antibodies, creating significant demand for advanced desensitization therapies. KJ103 targets this underserved segment by offering a potential alternative to conventional plasma-exchange regimens, which have shown limited efficacy in highly sensitized patients.

Risk statement The company cautions that clinical, regulatory and commercialization outcomes remain uncertain, and there is no assurance of eventual market approval or success.