Shanghai, China – August 4, 2025 – 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 that the supplemental application for the production expansion of NEFECON® has been officially approved by China's National Medical Products Administration (NMPA). NEFECON® is the first and only etiological treatment for IgA nephropathy (IgAN) to receive full approval in China, the United States, and Europe, providing a foundational first-line cornerstone treatment for IgAN patients. This approval for production expansion will further boost capacity and increase product supply, enabling a more efficient response to the growing clinical demand in China and across Asia.

“The expansion of our NEFECON® production capacity will help better meet the growing clinical treatment needs of IgAN patients in China.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. ““China has one of the highest rates of primary glomerular disease in the world, with more than 5 million patients estimated to be living with IgAN and over 100,000 new cases diagnosed each year. Chinese IgAN patients generally experience faster disease progression and poorer prognosis, highlighting a significant unmet medical need.

As the only etiological treatment for IgAN currently recommended by both international and Chinese guidelines, the expansion of NEFECON® production will further accelerate the uptake of etiological treatment, enabling more patients to access standardized treatment earlier to delay disease progression and protect kidney function. We will continue to enhance the accessibility and affordability of NEFECON®, supporting its advancement from ‘changing the treatment landscape’ to ‘redefining the standard of care.’”

NEFECON® specifically modulates the mucosal immune system in the gut to reduce the formation of pathogenic galactose-deficient IgA1 (Gd-IgA1) that trigger IgAN. Results from the Phase 3 clinical study NefIgArd demonstrated that NEFECON® reduces the decline in kidney function by 50%1. Results from Phase 3 clinical study NefIgArd of the Chinese population shows that NEFECON® reduces kidney function decline by 66%2, and delays disease progression to dialysis or kidney transplantation by 12.8 years3.

NEFECON® was first approved in November 2023 through NMPA’s priority review for the treatment of primary IgAN in adults at risk of disease progression. It was subsequently included in the National Reimbursement Drug List (NRDL) in November 2024, and received full approval from the NMPA in May 2025, irrespective of proteinuria levels, benefiting most individuals living with IgAN.

NEFECON®, as the only in-disease IgAN treatment has been included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (public review draft), making it the only targeted therapy endorsed by both international and Chinese guidelines. NEFECON® has been approved across all Everest Medicines’ territories, including mainland China, Hong Kong SAR, Macau SAR, Taiwan region, China, as well as 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, Macau, Taiwan (China) and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicines’ 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.

References

1.Lafayette R,et al. Lancet. 2023 Sep 9;402(10405):859-870.

2.2023ASN. Oral presentation.

3.Jonathan Barratt, et al. Clinical Kidney Journal, February 2025, sfae404.

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