Shanghai Bao Pharmaceuticals Announces Acceptance of New Drug Application for KJ103 for Injection
Date: June 4, 2026
Company: Shanghai Bao Pharmaceuticals Co., Ltd. (Stock Code: 2659)
Key Highlights
- The China National Medical Products Administration (NMPA) has officially accepted Shanghai Bao Pharmaceuticals’ New Drug Application (NDA) for KJ103 for Injection, aimed at desensitization therapy in highly sensitized kidney transplant patients.
- KJ103 has been granted priority review and approval status by the Center for Drug Evaluation of the NMPA, accelerating the regulatory process.
- KJ103 is a globally first-in-class recombinant immunoglobulin G (IgG)-degrading enzyme, designed to rapidly clear pre-existing HLA antibodies and help prevent hyperacute rejection in kidney transplants.
- The product has demonstrated a 100% success rate in desensitization therapy and kidney transplantation during Phase III clinical trials, with 100% graft survival at 3 months post-transplant.
- KJ103 was previously granted Breakthrough Therapy Designation by the NMPA for this indication in November 2024.
- The company is also exploring KJ103 in other acute antibody-mediated autoimmune diseases, including anti-glomerular basement membrane disease (anti-GBM disease) and Guillain-Barré syndrome (GBS).
- Compared to existing IgG-degrading enzymes, KJ103 is expected to offer a safer and more effective treatment with lower immunogenicity.
Details for Investors and Shareholders
Potential to Move Share Price: The acceptance of the NDA and the product’s inclusion in the priority review process are significant milestones that could positively impact the company’s valuation. The clinical data showing 100% success rates in key efficacy endpoints is likely to attract investor interest and potentially boost share prices.
Market Opportunity: Chronic kidney disease affects an estimated 13.4% of the global population, with 4.9–7.1 million patients needing kidney replacement therapy. Approximately 40% of waitlisted kidney transplant patients are highly sensitized, with pre-existing anti-HLA antibodies, making transplantation difficult and driving strong demand for innovative desensitization solutions like KJ103.
Product Differentiation: KJ103 is positioned as a first-in-class drug with the ability to specifically and effectively degrade human IgG, and its lower immunogenicity compared to current competitors could make it the preferred choice for challenging patient populations.
Pipeline Expansion: Beyond kidney transplantation, KJ103 is being developed for other acute autoimmune diseases, with Phase II clinical trial completed for anti-GBM disease and initiated for GBS, expanding its commercial potential.
Risks and Cautions
- The company cautions that successful development and commercialization of KJ103 are not guaranteed, as clinical trials, evaluations, and regulatory approvals are subject to significant uncertainties.
- Shareholders and potential investors should exercise caution when trading shares, considering the unpredictable factors in clinical development and regulatory review.
Board of Directors
The announcement is issued by Dr. Liu Yanjun, Chairman of the Board and Executive Director of Shanghai Bao Pharmaceuticals Co., Ltd., with a diverse board comprising executive, employee, non-executive, and independent non-executive directors.
Disclaimer
This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult professional advisers before making investment decisions. The information provided is based on the latest available company disclosures and may be subject to change.
