Everest Medicines Announces New Drug Application Acceptance by China NMPA for Nefecon for the Treatment of Primary IgA Nephropathy
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression
-- NDA acceptance takes Everest closer to making this first-in-disease treatment available for primary IgAN patients in China
-- China is home to the largest patient base for IgAN with estimated 5 million people with the disease and currently there is no approved treatment in the country
-- Nefecon is approved in the U.S. and E.U., and received Breakthrough Therapy Designation (BTD) in China
SHANGHAI, Nov. 14, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. The acceptance brings Nefecon, approved and marketed in the U.S. under the name TARPEYO® and in the E.U. as Kinpeygo®, an important step closer to becoming the first-ever therapeutic option indicated for IgAN treatment in China. The NMPA recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgAN in December 2020.
