SHANGHAI, April 24, 2023 /PRNewswire/ -- 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 Nefecon, the first-in-disease treatment for primary immunoglobulin A nephropathy (IgAN), has been approved by the Hainan Medical Products Administration for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary. The launch of this early-access program in Hainan marks the beginning of a new treatment era for IgA nephropathy in China, where Everest can now offer patients a targeted therapy that could fundamentally change their disease progression.
China has the highest prevalence of primary glomerular diseases in the world with an estimated 5 million IgAN patients. There are no approved therapies in the country, and while non-targeted options such as RAS inhibitors are used to treat IgAN, they do not fundamentally alter disease progression. Up to 50% of IgAN patients with disease progression are at the risk of kidney failure within 10-20 years, which may require dialysis or kidney transplant. There is a very significant unmet medical need among IgAN patients in China and other Asian countries.
"We are eager for IgAN patients in China to gain access to this first-in-disease, innovative medicine, with support from favorable national pharmaceutical innovation policy and the Hainan Boao Lecheng Pilot Zone, " said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Renal disease is one of Everest Medicines' core areas of focus. As the anchor product in the company's renal portfolio, Nefecon's early-access program will greatly enhance its awareness among the public and the medical community, and help accelerate the product's commercialization upon potential NDA approval later this year."
"As the world's first-in-disease treatment for IgA nephropathy, Nefecon can reduce the overproduction of pathogenic IgA1 from the origin. In phase 2 and phase 3 clinical studies, Nefecon has proven to significantly reduce the levels of Galactose-deficient IgA1 (Gd-IgA1) and IgA immune complexes in circulation, confirming it as a targeted treatment," 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.
According to the recent topline results from the global NefIgArd study, which investigated the effect of Nefecon versus placebo in patients with primary IgAN, the trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over a two-year period, comprised of nine months of treatment with Nefecon or placebo followed by 15 months of follow-up off drug. Treatment benefit on eGFR was apparent across baseline urine protein creatinine ratio (UPCR) subgroups, and sustained proteinuria effects and eGFR treatment benefits were observed 15 months after drug discontinuation, providing evidence for disease modification.
Nefecon has already been approved and marketed in the United States, the European Union and the UK. It was granted Breakthrough Therapy Designation and Priority Review status in China, and a decision from the National Medical Products Administration is expected in the second half of this year.
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 cardio-renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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