China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, intended for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been accepted for review by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. The company anticipates receiving NDA approval in Macao in 2023. This follows the acceptance of NDAs for the drug by regulatory bodies in mainland China and Singapore in November 2022 and April 2023, respectively.
Nefecon’s Mechanism and Patented Formulation
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. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, where the disease originates, according to predominant pathogenesis models.
Exclusive License Agreement with Calliditas
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. This agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories, further expanding the reach of Nefecon in the region.-Fineline Info & Tech
