Everest Medicines Announces Major Regulatory Updates in Taiwan and South Korea for Nefecon for the Treatment of Primary IgA Nephropathy
Everest Medicines (HKEX: 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today the Taiwan Food and Drug Administration and Ministry of Food and Drug Safety in South Korea have granted fast-tracked approval process to Nefecon®. Nefecon is our lead product in the renal disease portfolio as a first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN) and a New Drug Application (NDA) has been accepted in mainland China
-- Taiwan Food and Drug Administration grants Accelerated Approval Designation (AAD) to Nefecon --
-- Ministry of Food and Drug Safety in South Korea grants ODD to Nefecon --
-- Nefecon is a first-in-disease treatment for IgAN patients and has been approved in U.S. and E.U. --
SHANGHAI, Nov. 27, 2022 /PRNewswire/ -- Everest Medicines (HKEX: 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today the Taiwan Food and Drug Administration and Ministry of Food and Drug Safety in South Korea have granted fast-tracked approval process to Nefecon®. Nefecon is our lead product in the renal disease portfolio as a first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN) and a New Drug Application (NDA) has been accepted in mainland China.
