Everest Medicines Announces NMPA Full Approval of NEFECON, Broadening Treatment Access for IgA Nephropathy Patients in China

Everest Medicines announced today that the supplemental New Drug Application (sNDA) for NEFECON has been fully approved by the China National Medical Products Administration (NMPA). This approval expands the treatment options for adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, regardless of proteinuria levels. The previous requirement for elevated proteinuria has been eliminated.
NEFECON is now the first and only etiological treatment for IgAN to receive full approval in China, establishing its position as a first-line therapy and a major advancement in care for IgAN patients.
Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, stated that the approval of NEFECON in China is a significant milestone, providing a foundational first-line treatment for IgAN patients, addressing clinical needs, and reinforcing its efficacy and safety. With over 100,000 new cases of IgAN diagnosed annually in China, there is a significant need for effective treatment options. NEFECON’s inclusion in the National Reimbursement Drug List (NRDL) and availability in 31 provinces and cities will improve accessibility and affordability for patients.
The approval is based on data from the Phase 3 NefIgArd clinical trial, demonstrating NEFECON’s efficacy in preserving kidney function and supporting its clinical utility. In the China subpopulation of the trial, NEFECON reduced kidney function decline and delayed the need for dialysis or transplantation, showing its potential for long-term disease management in Chinese patients.
NEFECON is the first etiological treatment for IgAN approved by the U.S. FDA and the EMA, available in Everest Medicines territories including mainland China, Hong Kong, Macau, Singapore, Taiwan, and South Korea. Its full approval broadens its clinical use and represents a significant achievement in the renal disease sector, showcasing Everest Medicines’ commitment to providing innovative treatments for patients’ long-term benefit.