BRIEF—China NMPA recommends priority review for Nefecon for IgAN

Shares of Everest Medicines shot up 10% to HK$17.38 today, after it announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New Drug Application (NDA) of Nefecon, a new oral formulation of budesonide, for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression.

This marks another important advancement following the NMPA’s acceptance of the NDA in November 2022. Nefecon has also been granted Breakthrough Therapy designation for IgAN.

In June 2019, Shanghai, China-based Everest entered into an exclusive, royalty-bearing license agreement with Swedish firm Calliditas, which gave Everest 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 as part of Everest’s territories.