Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on the research and development, clinical development, manufacturing and commercialization of innovative drugs, announced today that the Taiwan Food and Drug Administration (TFDA) has approved NEFECON® (budesonide enteric-coated capsules, NEFECON®) for the treatment of adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) at risk of progression to delay renal function decline by 1, with no baseline proteinuria level restriction. This means that NEFECON®, as the world's first and only causal treatment for IgA nephropathy fully approved by the U.S. Food and Drug Administration (FDA), has further expanded its coverage, bringing new hope to more Chinese IgA nephropathy patients.

The results of the NefIgArd Phase 3 global clinical trial showed that compared with placebo, NefIgArd® not only brought about a lasting decrease in proteinuria and reduced the risk of microscopic hematuria, but more importantly, it showed clinically relevant and statistically significant treatment benefits in the estimated glomerular filtration rate (eGFR) (p<0.0001), which can reduce renal function decline by 50%, and is expected to delay the time from disease progression to dialysis or kidney transplantation by 12.8 years.

Taiwan, China is the fifth region in the authorized area of Everest Medicines to obtain approval for the marketing of NefIgArd® after Macau, China, Mainland China, Singapore and Hong Kong, China. As Everest Medicines' core product in the field of nephrology, Everest Medicines also submitted a new drug marketing authorization application in South Korea at the end of 2023 and successfully obtained acceptance, and issued the first prescription in mainland China in May this year. In addition, in July this year, the China National Drug Administration officially accepted the supplementary application for complete data of the final clinical trial stage of NefIgArd®, and NefIgArd® is expected to become the first and only fully approved causal treatment for IgA nephropathy in China.

In the recently released "2024 KDIGO Practice Guidelines for the Clinical Management of IgA Nephropathy and IgA Vasculitis (Draft for Public Review)", NEFECON® is recommended for 9 months of NEFECON® treatment in patients with IgA nephropathy at risk of disease progression (2B). In addition, NEFECON® is expected to be included in China's first IgA nephropathy diagnosis and treatment guidelines and recommended as a first-line treatment for patients with IgA nephropathy at risk of disease progression.

About NEFECON®

NEFECON® is budesonide enteric-coated capsules. As the world's first causal treatment for IgA nephropathy, it is an immunomodulator targeting intestinal mucosal B cells, which can reduce renal function decline by 50%2 and delay renal function decline by 66% in the Chinese population3. It is expected to delay the time from disease progression to dialysis or kidney transplantation by 12.8 years4. At the same time, the first-pass metabolism of budesonide reaches 90%5, which has good safety. Naifonide® is specially developed for patients with IgA nephropathy. Each capsule contains 4 mg of budesonide. Through a special delayed-release and sustained-release dual formulation process, budesonide is targeted and released to the mucosal B cells (including Peyer's patches) at the end of the ileum. After the capsule is dissolved, the three-layer coated micropellets continuously and stably release budesonide, covering the entire target area with high concentrations, thereby reducing the production of galactose-deficient IgA1 antibodies (Gd-IgA1) that induce IgA nephropathy, thereby intervening in the upstream stage of the pathogenesis and achieving the effect of treating IgA nephropathy.

In June 2019, Everest Medicines signed an exclusive licensing agreement with Calliditas Therapeutics to obtain the rights to develop and commercialize Naifonide® in Greater China and Singapore. The agreement was expanded in March 2022 to include South Korea in Everest Medicines' licensing scope.

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