China-based biotech Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its Nefecon, an oral budesonide-targeted release preparation. The drug is intended for the treatment of primary IgA nephropathy (IgAN) with a risk of progression. This marks a significant step forward in addressing a condition that affects approximately 5 million people in China, where no targeted therapy currently exists.
Licensing and Regulatory Milestones
Everest Medicines obtained exclusive development and commercialization rights to Nefecon in Greater China and Singapore through a licensing deal with Calliditas Therapeutics AB in June 2019. The drug has received orphan drug designations (ODDs) from both the US FDA and the European Medicines Agency (EMA). Nefecon was awarded breakthrough therapy designation (BTD) in China in December 2020 and received its first approval in the US in December 2021. In March 2022, Everest expanded the licensing deal to include South Korea.
Clinical Trial Results
The Part A of the NefIgArd study, which met primary endpoints in November 2020, demonstrated significant therapeutic benefits of Nefecon. After nine months of treatment, the urinary protein creatinine ratio (UPCR) of the Nefecon group decreased by 27% compared to the placebo group (P=0.0003). Specifically, the UPCR of the Nefecon group decreased by 31% from baseline, compared to a 5% decrease in the placebo group. In terms of renal function protection, the estimated glomerular filtration rate (eGFR) of the Nefecon group remained stable, decreasing only 0.17 ml/min/1.73m² from baseline, compared to a 4.04 ml/min/1.73m² decrease in the placebo group. The treatment benefit in eGFR for the Nefecon group was statistically significant at 3.87 ml/min/1.73m² (P=0.0014). Additionally, Nefecon was well-tolerated, with no serious infection-related adverse events reported.
China Subgroup Data
In April 2022, Everest published clinical data from the Nefecon China subgroup, which indicated that the results for proteinuria decline and stable glomerular filtration rate (eGFR) were consistent with the primary outcomes of the global Phase III NefIgArd A study. This further supports the potential of Nefecon as an effective treatment option for IgA nephropathy.-Fineline Info & Tech
