SHANGHAI, July 18, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that China's National Medical Products Administration（NMPA）has accepted the submission of a supplemental New Drug Application (sNDA) seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. NEFECON® is expected to become the first-in-disease IgA nephropathy (IgAN) treatment to receive full approval by the NMPA.
NEFECON® was first approved in November 2023 under China NMPA's accelerated approval pathway for the treatment of primary IgAN in adults at risk of disease progression. The U.S. Food and Drug Administration (FDA) had approved NEFECON® delayed release capsules for adults with primary IgAN who are at risk for disease progression, irrespective of proteinuria levels.
"NMPA's acceptance of the submission of NEFECON® sNDA further demonstrates the innovative advantages of this first-in-disease treatment for IgAN. IgAN is prevalent in the Asian population, which has 56% higher risk of progression to end-stage renal disease and faster disease progression. Since launching in China in May, NEFECON® has already opened a new era of IgAN treatment. With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "NEFECON® has undergone a 20-year research and development process and become the first approved medicine with the IgAN indication by the NMPA. It is also the first fully US FDA-approved treatment for adults with primary IgAN who are at risk for disease progression, irrespective of proteinuria levels. We look forward to working closely with the regulatory authority to bring this innovative treatment to all IgAN patients in China soon."
This supplemental application is based on the global Phase 3 NefIgArd clinical trial. The global Phase 3 NefIgArd clinical trial was a randomized, double-blind, multicenter study that 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. In the global study, NEFECON® demonstrated a statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with NEFECON® and 15-months of follow-up off drug. The reduction in urine protein creatinine ratio (UPCR) observed with NEFECON® treatment was also durable and the proportion of patients with microhematuria in the NEFECON® group declined.
Results from the Chinese subpopulation analysis demonstrated numerically greater magnitude of NEFECON® treatment effect compared with placebo in kidney function, proteinuria and microhematuria. The mean absolute change from baseline in eGFR at 24 months showed approximately 66% less deterioration in kidney function with NEFECON® compared with the global population which demonstrated a 50% less reduction in loss of kidney function. Patients treated with NEFECON® in mainland China showed a 31% reduction (95% CI 0%, 53%) in UPCR compared with placebo at 9 months and a 43% (95% CI 8%, 65%) reduction at 24 months. This compares to the global data analysis in which patients treated with NEFECON® recorded an approximately 30% reduction in proteinuria at both 9 months and 24 months compared to placebo. NEFECON® was generally well tolerated, with a safety profile in the Chinese population generally consistent with the larger global study. The Chinese patient data were presented at the American Society of Nephrology (ASN) Kidney Week 2023.
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 Therapeutics, 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.
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. For more information, please visit its website at www.everestmedicines.com.
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