Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced  that its New Drug Application (NDA) for Nefecon® has been accepted for review by the Taiwan Food and Drug Administration (TFDA) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients.

"Following our recent NDA approval for Nefecon® in China and NDA acceptance in South Korea, we are pleased to announce that we have quickly expanded to another one of our territories with NDA acceptance in Taiwan. The Asian population has high prevalence of IgAN and significant risk of progression to end-stage renal diseases," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We look forward to the opportunity of offering Nefecon® to patients throughout Asia including Singapore, Hong Kong, Taiwan and South Korea in 2024, as well as to the five million IgAN patients in Mainland China."

The Taiwan Food and Drug Administration granted Accelerated Approval Designation (AAD) to Nefecon® in Nov. 2022. Everest's licensing partner Calliditas Therapeutics AB announced on Dec. 20 that Nefecon® is now the first and only fully FDA-approved treatment for IgAN based on a measure of kidney function.

The Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study, evaluated the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The NefIgArd study is a 2-year trial, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off study drug. The primary endpoint, time-weighted average of eGFR over 2 years, showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value < 0.0001). It also showed a difference in 2-year total eGFR slope of 2.95 mL/min per 1.73 m² per year in favor of Nefecon®. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline level.

The full two-year results of the NefIgArd trial (n=364 patients) were further analyzed to assess potential differences in response to Nefecon® treatment based on self-reported Asian (n=83) or White (n=275) ancestry in patients with IgAN. Treatment with Nefecon® 16 mg/day over a 9-month period resulted in clinically meaningful preservation of kidney function in both subgroups, as evidenced by reduction in proteinuria and stabilization of eGFR in these two subgroups when compared to placebo.