Everest Medicines Announces New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy
Everest Medicines 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.
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 reaches the Peyer's patch region of the lower small intestine. 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.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on 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, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
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