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 today that the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, has approved its New Drug Application (NDA) for Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Macau is the first region in Everest territories that received Nefecon® NDA approval.
“We are excited that Nefecon®, the world’s first treatment for IgA nephropathy approved by the U.S. FDA and EU EMA and the leading product in our renal portfolio, will soon be accessible to IgAN patients in Macau,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “The NDA approval in Macau is our first step in bringing Nefecon® to patients around Asia and marks the beginning of a new treatment era for IgA nephropathy in this region, with a targeted therapy that could fundamentally change their disease progression. We look forward to having Nefecon® approved in mainland China and Singapore later this year, followed by Hong Kong, South Korea and Taiwan next year.”
“IgA nephropathy is the most common primary glomerular disease in China and occurs at a young age with poor prognosis. A significant portion of IgAN patients with disease progression are at risk of kidney failure. Overall results from the NefIgArd study indicate that Nefecon® can reduce decline in kidney function and delay progression to dialysis or kidney transplantation,” said Professor Zhang Hong with Peking University First Hospital, who is a member of the global steering committee for the Phase 3 clinical study NefIgArd. “Nefecon®’s approval in Macau will allow this first-in-disease medicine to benefit Chinese IgAN patients as soon as possible.”
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.
Nefecon® has already been approved and marketed in the United States, the European Union and the UK. The NDA for Nefecon® in mainland China is under Priority Review and Nefecon® was the first non-oncology medicine to receive Breakthrough Therapy Designation in China. Nefecon® has been available for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary through an early-access program since April 2023.