China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore has accepted for review the New Drug Application (NDA) for its Nefecon (targeted-release formulation-budesonide) for adult patients with IgA nephropathy at risk of disease progression. The drug is anticipated to receive approval within the year.
Nefecon: A Potent Corticosteroid for IgA Nephropathy
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. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, securing 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 within Everest’s territories.
Global Recognition and Regulatory Progress
The drug, which holds orphan drug designations (ODDs) in the US and EU, obtained priority review status in China in November last year, with approval expected later this year. Nefecon is the first non-tumor product with breakthrough therapy designation (BTD) status in China and 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.-Fineline Info & Tech
