Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for Nefecon (targeted-release formulation budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression has been approved by the National Medical Products Administration (NMPA).
Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first-pass metabolism. The formulation is designed as a delayed-release capsule that is enteric coated to remain intact until it reaches the Peyer’s patch region of the lower small intestine. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, granting Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. The agreement was extended in March 2022 to include South Korea within Everest Medicines’ territories. The drug received marketing approval in Macau last month.- Flcube.com
