Everest Medicines Announces Full Approval of NEFECON® in Taiwan
SHANGHAI, Aug. 6, 2025 /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 the Taiwan Food and Drug Administration (TFDA) has approved the supplementary application for NEFECON®. NEFECON® is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression, irrespective of proteinuria levels.
With this label update, the previous requirement in accelerated approval stage to submit full confirmatory trial analysis to demonstrate clinical benefit has been formally removed. Additionally, data demonstrating NEFECON®'s efficacy in delaying kidney function decline has been included in the approved product label. IgAN is highly prevalent among Asian populations, with a 56% higher risk of progression to end-stage renal disease compared to other groups and often progresses more rapidly[1].
Taiwan region became the last region across all Everest's territories to grant full approval for NEFECON®, together with Mainland China, Singapore, Macao SAR, Hong Kong SAR and South Korea. This further demonstrates NEFECON®'s foundational first-line cornerstone treatment for IgAN patients.
"NEFECON® has received full approval in Taiwan, further validating its outstanding clinical value and offering physicians a more solid clinical foundation for treatment decisions." Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said. "As the first and only fully approved etiological treatment for IgAN, NEFECON® has now achieved full approval across Asia. This milestone will benefit a broader patient population by enabling more individuals with IgAN to access this etiological treatment earlier, helping to slow disease progression and improve quality of life. We will continue to expand the accessibility and affordability of NEFECON® across Asia, aiming to benefit more IgAN patients and improve their quality of life."
The approval is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, it not only brought about a durable reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR), reducing the decline in kidney function by 50% over a period of 2 years[2], comprising 9 months of treatment and 15 months of observation, and potentially delaying the progression to dialysis or kidney transplantation by 12.8 years[3].
Additionally, the complete 2-year data of the NefIgArd study[4] further analyzed the potential differences in the response to NEFECON® treatment between Asians (n=83) and Caucasians (n=275). The results showed that compared to placebo, treatment with NEFECON® for 9 months in both Asians and Caucasians can significantly delay the decline of eGFR, protect kidney function, and bring about a sustained reduction in proteinuria and reduce the risk of microscopic hematuria.
NEFECON® has been recommended by several authoritative treatment guidelines, including the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (Public Review Draft)"[5], and the "Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis in Chinese Adults (For Public Review)". NEFECON® was included in China's National Reimbursement Drug List (NRDL) in November 2024, and the supplemental application for the production expansion of NEFECON® has been officially approved by NMPA in August 2025.
NEFECON® is currently the world's first IgAN treatment to have received full approval from the National Medical Products Administration (NMPA) in China, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency（MHRA）in the United Kingdom , as well as in other Asian territories where Everest Medicines holds the rights, including Hong Kong SAR, Macao SAR, Taiwan region (China), Singapore, and South Korea.
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 SAR, Macao SAR, Taiwan (China) 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
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.
Reference:
1. Sean J. Barbour, et al. Kidney International (2013) 84, 1017–1024.
2. Lafayette R, et al. Lancet. 2023 Sep 9;402(10405):859-870.
3. Jonathan Barratt, et al. Clinical Kidney Journal, February 2025, sfae404. https://doi.org/10.1093/ckj/sfae404
4. Jonathan Barratt, et al. 2024 WCN. Poster WCN24-1674. WCN24-1674 NEFECON TREATMENT RESPONSE IN ASIAN AND WHITE PATIENT POPULATIONS WITH IMMUNOGLOBULIN A NEPHROPATHY: A 2YEAR ANALYSIS OF THE PHASE III NEFIGARD TRIAL - ScienceDirect
5. https://doi.org/10.34067/kid.0000000583DRAFT of KDIGO 2024 CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF IMMUNOGLOBULIN A NEPHROPATHY (IgAN) AND IMMUNOGLOBULIN A VASCULITIS (IgAV)
SOURCE Everest Medicines
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