[News] KJ103 (Ricefidase) Designated as a Breakthrough Therapy

On November 20, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) included "KJ103 for Injection", developed by Shanghai Bao Pharmaceuticals Co., Ltd. ("Bao Pharma"), in the Breakthrough Therapy Designation (BTD) list. The proposed indication is desensitization therapy for highly sensitized kidney transplant patients, effectively removing pre-existing HLA antibodies to prevent hyperacute rejection.
KJ103 (Ricefidase) is an innovative biologic independently developed by Bao Pharma with a global patent portfolio. It is classified as a Class 1 therapeutic biological product under China’s drug registration system. Bao Pharma submitted the Breakthrough Therapy Drug Evaluation Procedure application to the CDE on October 15, 2024. Following a review and public announcement process (public notice deadline: November 19, 2024), the CDE officially granted Breakthrough Therapy Designation on November 20, 2024.
This designation reflects regulatory authorities' commitment to supporting innovative drug development through policy-level incentives. Encouraged by this recognition, Bao Pharma will leverage the benefits of Breakthrough Therapy Designation to actively engage with the CDE on key topics such as pivotal clinical trial design, approval pathways, and overall drug development strategy. The company is committed to increasing investment in the development of KJ103 for Injection, accelerating its commercialization, and providing safe and effective treatment options for patients in need.