By Fineline Cube 
China-based Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has converted the conditional approval to complete approval for its Nefecon (targeted-release budesonide) as a treatment for adult primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. This full approval lifts the restriction on proteinuria levels and makes Nefecon the first and only etiological treatment for the condition in China.
Clinical Trial Results
The NMPA’s decision is based on the final complete data from the Phase III Nef Ig Ard study, a randomized, double-blinded, multi-center study assessing the efficacy and safety of Nefecon (16 mg, once daily) in adult patients with primary IgAN receiving optimized RAS inhibitor therapy. The study lasted for 2 years, including a 9-month treatment period with Nefecon or placebo, followed by a 15-month follow-up period after discontinuation of medication. Global results show that compared to placebo, Nefecon not only brings persistent proteinuria reduction and reduces the risk of microscopic hematuria but also shows clinical significance and statistical differences (P<0.0001) in estimating glomerular filtration rate (eGFR), reducing renal function decline by up to 50%. Data in the Chinese population shows that Nefecon can delay renal function decline by up to 66% and is expected to delay the progression of the disease to dialysis or kidney transplantation by 12.8 years.
Licensing and Market Expansion
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, giving Everest exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, and Singapore. That deal was expanded to include South Korea in March 2022. Nefecon was conditionally approved for marketing in November 2023 in China to treat primary IgAN in adults at risk of disease progression, followed by marketing nods in South Korea, Singapore, Hong Kong, and Taiwan.-Fineline Info & Tech