【News】 Bao Pharma’s “KJ103 for Injection” Receives NMPA Approval for New Indication Clinical Trial

【News】 Bao Pharma’s “KJ103 for Injection” Receives NMPA Approval for New Indication Clinical Trial

On April 25, 2025, Shanghai Bao Pharmaceuticals Co., Ltd. (“Bao Pharma”) was granted a Clinical Trial Approval Notice by the National Medical Products Administration (NMPA) for a new indication of “KJ103 for Injection”.

“KJ103 for Injection” is classified as a Category 1 therapeutic biological product. This approval marks the third clinical trial authorization for KJ103 in China, with the newly approved indication for the treatment of Guillain-Barré Syndrome (GBS).

About KJ103

KJ103 is a novel, low-immunogenicity IgG-degrading enzyme derived from a non-pathogenic subspecies of Streptococcus equi. Its unique and efficient mode of action enables rapid degradation of pathogenic IgG antibodies within one hour of administration, leading to effective symptom relief in IgG-mediated diseases. KJ103 has demonstrated a favorable safety and tolerability profile in clinical evaluations.

Independently developed by Bao Pharma, KJ103 has established a global patent portfolio. It offers broad therapeutic potential, including applications in desensitization protocols for highly sensitized kidney transplant recipients and in the rapid management of acute and severe autoimmune diseases, providing a critical therapeutic window for subsequent interventions.

Currently, KJ103 has successfully completed Phase I clinical trials in both New Zealand and China, achieving positive results. The Phase II trial in highly sensitized kidney transplant patients has yielded encouraging top-line data, and a Phase III clinical trial is currently ongoing. Enrollment for the Phase II study targeting anti-GBM disease has been completed. Furthermore, KJ103 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of a broad spectrum of autoimmune diseases mediated by pathogenic IgG antibodies.

Bao Pharma remains committed to advancing the clinical development of “KJ103 for Injection” in strict accordance with regulatory requirements, expediting clinical research progress, and ensuring the integrity and robustness of safety and efficacy data. Bao Pharma strives to bring KJ103 to market at the earliest opportunity to address significant unmet medical needs and offer new hope to patients suffering from acute and severe autoimmune diseases.