BAO PHARMA-B (02659) has announced a major breakthrough: the global first low-sensitive IgG degradation enzyme Ricefidase has successfully completed Phase II clinical trials, potentially bringing the first drug therapy for anti-GBM disease.

At the 63rd European Renal Association (ERA) Congress, the results of a Phase II, open-label, single-arm, multicenter study led by Professor Zhao Minghui and the team from Peking University First Hospital, sponsored by BAO PHARMA-B(02659), on the early multiple doses of the novel IgG degrading enzyme Ricefidase (KJ103) treatment for anti-GBM disease were officially announced, attracting attention from the international nephrology community. The study showed that Ricefidase, in combination with standard immunosuppressive therapy, can achieve rapid and sustained clearance of anti-GBM antibodies and suggest potential benefits in some key clinical outcomes, providing a new direction for the treatment of this life-threatening rare autoimmune disease. KJ103 is a globally first recombined low immunogenicity IgG degrading enzyme used to treat various immune diseases mediated by pathological IgG antibodies. This product specifically cuts and degrades pathological IgG antibodies circulating in the blood, inhibiting immune response activation, and providing a targeted, rapid treatment option for antibody-mediated autoimmune diseases. Landing on an important international nephrology academic platform The ERA Congress is one of the important academic conferences in the field of global nephrology and an important academic exchange platform in the international nephrology community, alongside ASN Kidney Week. The conference brings together global nephrology experts and researchers to showcase the latest research advances in the field. The release of the Phase II clinical data of Ricefidase in this conference signifies the further entry of related research results into the international academic exchange perspective. Anti-GBM disease: a highly lethal rare disease with significant unmet treatment needs Anti-GBM disease is a rare but rapidly progressive autoimmune disease mediated by anti-glomerular basement membrane antibodies (mainly IgG), which can lead to rapid progressive renal failure and pulmonary hemorrhage. Patients have a low long-term survival rate, severely impaired quality of life, high mortality rates, and bring a heavy burden of disease and economic to families and society. Currently, patients with anti-GBM disease lack standardized treatment options, and there are no formally approved treatment drugs. Existing clinical strategies cannot achieve rapid clearance of anti-GBM antibodies, leading to poor overall prognosis. Most patients eventually progress to end-stage renal disease and find it difficult to obtain clear clinical benefits from current treatments. Ricefidase: Mechanism exploration of a novel IgG degrading enzyme Ricefidase is a new IgG degrading enzyme developed by Baoji Pharmaceutical based on protein modification from streptococcus, which specifically cuts and clears circulating IgG antibodies, quickly reducing the levels of pathogenic antibodies. Its features include lower pre-existing antibody levels and the potential to support short interval repetitive dosing, providing possibilities for multiple dosing regimen design. Phase II study results suggest potential clinical benefits The results show that multiple doses of Ricefidase in addition to standard immunosuppressive therapy can achieve rapid and sustained control of anti-GBM antibodies and show an improvement trend in key endpoints such as 6-month dialysis-free survival rate. In addition, patients receiving the three-dose regimen did not require plasma exchange therapy during the study, suggesting that this regimen may reduce reliance on traditional clearance methods. These results provide important evidence for further conducting Phase III confirmatory clinical studies. Baoji Pharmaceutical will continue to collaborate with clinical research centers such as Peking University First Hospital to accelerate the subsequent clinical development of Ricefidase in the anti-GBM disease field.