China-based Everest Medicines (HKG: 1952) has announced that Nefecon (delayed-release budesonide), the first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN), has been approved by the Hainan Medical Products Administration for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary. This marks the beginning of a new treatment era for IgA nephropathy in China, where Everest can now offer patients a targeted therapy that could fundamentally change disease progression.
Nefecon: A Targeted Therapy for IgAN
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 and Regional 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. This agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories. The drug is expected to obtain approval in China later this year, with a market filing accepted for review in November 2022, followed by a priority review status.
Regulatory Recognition and Program Inclusion
Nefecon, the first non-tumor product with breakthrough therapy designation (BTD) status in China, was included in the Global Innovative Fast Track (GIFT) program in South Korea in February this year. Additionally, an accelerated approval designation was awarded to the drug in Taiwan in November of last year, highlighting the significance of Nefecon in addressing the unmet medical needs of IgAN patients.-Fineline Info & Tech
