[News] Bao Pharma’s “KJ103 for Injection” Receives Clinical Trial Approval from NMPA

On August 22, 2024, Shanghai Bao Pharmaceuticals Co., Ltd. ("Bao Pharma") received the Clinical Trial Approval Notification from the National Medical Products Administration (NMPA) for its investigational drug KJ103 for Injection.
Classified as a Class 1 therapeutic biological product, this approval marks the second clinical trial of KJ103 in China, specifically for the treatment of anti-glomerular basement membrane (GBM) disease.
About KJ103
KJ103, also known as Ricefidase, is a novel IgG-degrading enzyme with low immunogenicity, derived from the non-human pathogenic bacterium Streptococcus equi ssp. equi. With a unique and highly efficient mechani**, it rapidly degrades pathogenic IgG antibodies within one hour of administration, effectively alleviating symptoms of IgG-mediated diseases while demonstrating a favorable safety and tolerability profile.
Developed independently by Bao Pharma, KJ103 has a global patent portfolio and broad therapeutic potential, including:
•    Desensitization therapy for highly sensitized kidney transplant patients to reduce pre-existing antibodies and prevent rejection.
•    Rapid symptom relief for acute and severe autoimmune diseases, providing a critical treatment window for further intervention.
KJ103 has successfully completed Phase I clinical trials in both New Zealand and China, demonstrating positive outcomes. In a Phase II clinical trial for highly sensitized kidney transplantation, the drug has shown promising topline results. A Phase III clinical trial is now being initiated.
Additionally, KJ103 has received FDA approval for clinical trials targeting a broad range of autoimmune diseases caused by pathogenic IgG.