Everest Medicines (HKG: 1952) today announced that the supplemental New Drug Application (sNDA) for NEFECON has received full approval from the China National Medical Products Administration (NMPA). This regulatory milestone significantly broadens the treatment population, allowing NEFECON to be used to reduce the loss of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, regardless of proteinuria levels. The prior limitation requiring elevated proteinuria has now been removed.
With this latest approval, NEFECON becomes the first and only etiological treatment for IgAN to receive full approval in China, reaffirming its position as a foundational first-line therapy and marking a major advancement in the standard of care for IgAN patients.
“The full approval of NEFECON in China marks a significant milestone, providing a foundational first-line treatment for IgAN patients, regardless of proteinuria levels, and addressing critical unmet clinical needs,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “As the first and only etiological treatment for IgAN in China to receive full approval from the NMPA, this further reinforces NEFECON’s proven clinical efficacy and safety, providing a solid foundation for treatment decision-making. With over 100,000 new cases diagnosed annually in China, there is a substantial unmet medical need. NEFECON’s inclusion in the National Reimbursement Drug List (NRDL), with reimbursement now available in 31 provinces and cities, is key to improving accessibility and affordability for patients.”
The NMPA’s full approval is supported by robust efficacy and safety data from the global Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating NEFECON (16 mg once daily) compared with placebo in patients on optimized RASi therapy. In the global cohort, NEFECON demonstrated a statistically significant and clinically meaningful benefit in preserving estimated glomerular filtration rate (eGFR) over a two-year period-comprising 9 months of treatment and 15 months of follow-up off drug. NEFECON also showed durable reductions in urine protein creatinine ratio (UPCR) and a decline in microhematuria, further supporting its clinical utility.
In the China subpopulation of the Global Phase 3 NefIgArd Clinical Trial, NEFECON reduced the rate of kidney function decline by 66% and delayed the need for dialysis or kidney transplantation by 12.8 years, reinforcing its transformative potential for long-term disease management in Chinese patients.
As the first IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), NEFECON has been approved across all Everest Medicines territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan(China), as well as Singapore and South Korea. It is now commercially available in mainland China, Hong Kong, Macau, and Singapore, with anticipated launches in Taiwan(China), and South Korea later this year, benefiting IgAN patients in all authorized regions.
The full approval of NEFECON not only broadens its clinical applicability, allowing more IgAN patients to benefit from targeted therapy earlier in their disease progression, but also represents a significant advancement in Everest Medicines leadership in the renal disease sector. This milestone further demonstrates Everest’s dedication to accelerating access to innovative treatments that address critical unmet medical needs and provide long-term value for patients, healthcare systems, and society.