Everest Medicines (HKG: 1952), a biopharmaceutical company dedicated to addressing critical medical needs in Asian markets, has achieved a significant step with its supplementary market approval filing for Nefecon being accepted by China’s National Medical Products Administration (NMPA). The drug, which targets the root cause of immunoglobulin A nephropathy (IgAN), is anticipated to become the first fully approved etiological treatment for this condition in China .
In 2019, Everest Medicines entered into an exclusive license agreement with Calliditas, securing rights to develop and commercialize Nefecon in Greater China and several Southeast Asian markets. This agreement was expanded to include South Korea in 2022. The drug received conditional approval for marketing in China in November 2023 .
The supplementary filing is supported by comprehensive data from the Phase III NefIgArd study, a randomized, double-blind, multi-center trial that evaluated Nefecon’s efficacy and safety in adult patients with primary IgAN. The study demonstrated that Nefecon not only significantly reduced proteinuria and the risk of microscopic hematuria but also showed a clinically and statistically significant improvement in estimated glomerular filtration rate (eGFR), slowing renal function decline by up to 50% .
The acceptance of the filing by the NMPA is a positive indicator for Everest Medicines as it moves towards full approval and commercialization of Nefecon in China. This development is crucial for the company, which is focused on nephrology and has been granted Breakthrough Therapy Designation and Priority Review for Nefecon in China . The drug’s potential approval is expected to be a game-changer for the treatment of IgAN, a disease that affects a large population in China and lacks targeted treatment options .
Everest Medicines is committed to bringing innovative therapies to patients in need, and the anticipated approval of Nefecon could mark a new era in the treatment of IgAN, offering a targeted approach to disease management and potentially improving patient outcomes .- Flcube.com
