China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, a treatment for primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. This marks the first regional approval of Nefecon within Everest’s territories.
Nefecon’s Mechanism and Approval Significance
Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid known for its potent glucocorticoid activity and weak mineralocorticoid activity. The drug’s formulation is designed to remain intact until it reaches the Peyer’s patch region of the lower small intestine, where it targets mucosal B-cells in the ileum, the site where IgAN originates according to predominant pathogenesis models.
License Agreement and Expansion
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, further expanding Everest Medicine’s territories and underscoring the company’s commitment to bringing innovative treatments to patients across the region.
Conclusion
The approval of Nefecon in Macau is a significant milestone for Everest Medicines, highlighting the company’s progress in advancing treatments for IgAN and its dedication to addressing unmet medical needs in the region. This approval paves the way for the potential introduction of Nefecon in other regions within Everest’s territories, offering hope to patients suffering from this progressive kidney disease.-Fineline Info & Tech
