World's First Low-Immunogenic IgG-Degrading Enzyme — Ricefidase Phase III Clinical Trial Officially Launched

— A Breakthrough Therapy for Highly Sensitized Kidney Transplantation

On March 29, 2025, Bao Pharma successfully held the National Kick-off and Protocol Review Meeting for the Phase III Clinical Trial of KJ103 (Recombinant Immunoglobulin G-degrading Enzyme Ricefidase for injection) in Highly Sensitized Kidney Transplantation in Wuhan, marking China’s first innovative desensitization therapy for highly sensitized kidney transplant patients entering a pivotal clinical stage.

The meeting was led by Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, with Professor Zhishui Chen, Director of the Organ Transplantation Institute, serving as the national principal investigator. More than 50 clinical experts from 8 leading transplant centers participated in the event, which combined online and offline discussions to comprehensively review and refine the Phase III clinical trial protocol.

As the first low-immunogenic IgG-degrading enzyme worldwide to advance into Phase III clinical development, Ricefidase has demonstrated breakthrough therapeutic efficacy in its Phase II study.

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Academic Leadership: Building a High-Standard Research Framework

In his opening remarks, Professor Zhishui Chen emphasized: “Highly sensitized patients account for a substantial proportion of those on kidney transplant waiting lists, yet effective standardized treatments have long been lacking. The Phase II data of Ricefidase showed that after drug treatment, 100% of highly sensitized patients achieved graft survival at six months’ post-transplantation, demonstrating the potential to establish a new paradigm in desensitization therapy. Today’s Phase III trial launch marks an important step forward in our research on highly sensitized kidney transplantation. I firmly believe that with the joint efforts of all experts, we will achieve a successful Phase III trial and deliver better therapeutic options and more effective medicines for these patients.”

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Industrial Commitment: Advancing High-Quality Clinical Research

Ms. Zheng Wang, CEO of Bao Pharma, stated: “KJ103 has shown remarkable efficacy and reliable safety in highly sensitized patients, rekindling hope for countless individuals waiting for organ transplantation. The Phase III trial is not only a crucial step in drug development but also a major stride toward our mission of ‘benefiting people’s health.’ Bao Pharma will fully dedicate the necessary resources and work hand in hand with all participating investigators to ensure a high-quality clinical study, accelerating the path to market for this innovative therapy and enabling more highly sensitized patients to escape the agony of waiting and regain healthy lives.”

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Clinical Value: Addressing a Century-Long Challenge in Transplant Medicine

During the meeting, experts comprehensively reviewed Phase II clinical data of KJ103, and focused on discussions regarding Phase III trial design, endpoint evaluation criteria and safety monitoring. Constructive feedback was provided on key aspects such as inclusion/exclusion criteria and laboratory asses**ent frequency, laying a solid foundation for the successful implementation of the Phase III study.

This meeting not only brings new hope to millions of highly sensitized patients worldwide awaiting organ transplantation but also highlights a transformative leap in China’s innovative drug development—from “Me-too” to “First-in-class.” Once validated, the Phase III results are expected to become a valuable addition to the “Guidelines for Immunosuppressive Therapy in Kidney Transplant Recipients”, representing a historic transition for China in the field of transplant desensitization therapy—from follower to global leader.

Bao Pharma will continue to collaborate closely with clinical experts to develop a “China Solution” for organ transplantation treatment, contributing new health-technology momentum to the shared future of humanity.

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According to the R&D team, Ricefidase’s indication expansion into acute severe autoimmune diseases is already under active investigation.