By Fineline Cube 
China-based Everest Medicines (HKG: 1952) announced today that the Taiwan Food and Drug Administration (TFDA) has granted full approval for the supplemental application of Nefecon (budesonide delayed-release capsules). Nefecon is indicated to reduce the decline in kidney function in adults with primary immunoglobulin A (IgA) nephropathy who are at risk of disease progression.
Regulatory Approval Details
This full approval removes the previous condition in the product label that required submitting the complete confirmatory trial analysis to demonstrate clinical benefits. With this approval, Nefecon has now achieved full approval across all of Everest Medicines’ licensed territories, including mainland China, Singapore, Hong Kong, Macau, and South Korea.
Product Overview
Nefecon is an oral, delayed-release capsule formulation of budesonide. It was developed to target the reduction of disease progression in patients with primary IgA nephropathy. The drug has demonstrated significant clinical benefits in reducing the decline of kidney function in affected adults.
Licensing and Expansion
In June 2019, Everest Medicines entered into an exclusive licensing agreement with Calliditas to develop and commercialize Nefecon in Greater China and Singapore. This agreement was expanded in March 2022 to include South Korea within Everest’s licensed territory. With this latest approval, Nefecon reinforces its position as a key treatment option for IgA nephropathy across Asia.-Fineline Info & Tech