Everest Medicines, a biopharmaceutical business based in Hong Kong that specialises in new treatments, has reported a significant milestone for its flagship drug, Nefecon, a patented oral formulation of budesonide, a corticosteroid noted for its powerful glucocorticoid effect. Its delayed-release capsules target mucosal B-cells in the ileum, the disease's major site, making it a pioneering therapy option as China's new National Reimbursement Drug List (NRDL) goes into effect on January 1, 2025. This action will greatly benefit people suffering from IgA nephropathy (IgAN), a chronic kidney disease.

Nefecon, which has been on the NRDL since November 2024, is the first and only medication capable of addressing the cause of IgAN approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and China's National Medical Products Administration. In November 2023, the NMPA approved Nefecon's New Drug Application (NDA) under a Priority Review process, marking a watershed moment in IgAN treatment in China.

The inclusion of Nefecon in the NRDL assures that patients can obtain the medication at a lower cost at specified medical institutions or pharmacies due to government reimbursement procedures. "With NRDL reimbursement, Nefecon will be accessible to more patients, alleviating their financial burden and improving health outcomes," Everest said.

This increased accessibility is crucial for IgAN patients in China, as the condition frequently causes serious consequences, such as dialysis or kidney replacement. Nefecon's inclusion in the NRDL emphasises the necessity of developing breakthrough medications to improve patients' lives.

The Phase 3 NefIgArd study's Chinese population results demonstrate Nefecon's therapeutic efficacy. The medicine slows the decline in kidney function by 66% and delays disease progression to dialysis or transplantation by an average of 12.8 years. Its novel mechanism and efficacy have resulted in recommendations in various authoritative guidelines, including the KDIGO 2024 Clinical Practice Guideline for IgAN and IgAV.

A representative for Everest Medicines emphasised the significance of these findings: "The clinical evidence reinforces Nefecon's potential to transform the treatment landscape for IgAN." Nefecon targets mucosal B-cells in the ileum, addressing the disease at its source. 

Everest Medicines has exclusive rights to develop and commercialise Nefecon in China, Hong Kong, Macau, Taiwan, Singapore, and South Korea under a licensing arrangement with Calliditas Therapeutics. According to the business, with the NRDL update now in force, Nefecon is on track to improve the quality of life for thousands of IgAN patients across China.