Everest Medicines’ Nefegan Approved by Singapore HSA for Primary IgAN Treatment

Everest Medicines (HKG: 1952), a China-based biotechnology company, has received marketing approval from the Singapore Health Sciences Authority (HSA) for its drug Nefegan, also known as Nefecon, which is indicated for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression.

Nefecon is a patented oral delayed-release formulation of budesonide, a corticosteroid with significant glucocorticoid activity and minimal mineralocorticoid activity. The drug is designed to undergo substantial first-pass metabolism, with a delayed-release capsule that is enteric coated to release budesonide to the distal ileum. The capsule contains coated beads targeting mucosal B-cells in the ileum, where IgAN is believed to originate according to predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive license agreement with Calliditas, which granted Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. This agreement was expanded in March 2022 to include South Korea within Everest Medicines’ territories. The drug has previously received marketing approval in mainland China and Hong Kong in October and November 2023, respectively.- Flcube.com

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