Shanghai, China – March. 20, 2024 — Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Singapore Health Sciences Authority (HSA) has approved NEFEGAN® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. NEFEGAN®, known in other Everest territories as Nefecon®, was the first ever treatment for IgAN fully approved by the U.S. Food and Drug Administration, and Singapore marks the third region in Everest territories that received New Drug Application (NDA) approval after Macao and mainland China.

"The NDA approval in Singapore marks an important event for IgAN patients in the region as we continue to expand patient access to Nefecon® throughout Asia, an area of high IgAN disease prevalence," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Following approval of Nefecon® in mainland China and commercial launch in Macao, we are working to rapidly expand availability of this first-in-disease therapy which targets the origin of the disease and can slow disease progression to more underserved patients in 2024 including Hong Kong, Taiwan and South Korea.”

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.

About Nefecon®

Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories. The brand name in Singapore is NEFEGAN®.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.

https://www.everestmedicines.com/news/everest-medicines-announces-singapore-health-sciences-authority-approves-nefegan-for-the-treatment-of-primary-iga/46983947-1c1b-4c4c-8914-5dc5cf355116/