Everest Medicines Announces the Implementation of NEFECON National Reimbursement Drug List Pricing in China for the Treatment for IgA Nephropathy

By: Everest Medicines Limited via ACN Newswire

January 01, 2025 at 20:59 PM EST

SHANGHAI, China - January 2, 2025 - (ACN Newswire) - 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 with the official implementation of the latest update of the National Reimbursement Drug List ("NRDL") on January 1, 2025, NEFECON(R) will apply the NRDL pricing, which will benefit more IgA nephropathy (IgAN) patients.

NEFECON(R) was included in the NRDL in November 2024. As the first IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), NEFECON(R) received NDA approval from the National Medical Products Administration (NMPA) of China in November 2023 through Priority Review. It is the only approved treatment for primary IgAN in adults at risk of disease progression in China.

Based on policies in various provinces and cities, NEFECON(R) will be eligible for NRDL reimbursement starting in January. Patients will be able to obtain the medication at designated medical institutions or pharmacies and benefit from the reimbursed pricing. The official implementation of the NRDL will expand the accessibility of NEFECON(R), alleviate the financial burden on patients, and enable more IgAN patients in China to benefit from this innovative drug.

Results from the Chinese population of the Phase 3 clinical study NefIgArd study shows that NEFECON(R) reduces kidney function decline by 66%, and delays disease progression to dialysis or kidney transplantation by 12.8 years. With its innovative mechanism of action and clinical advantages, NEFECON(R) has been recommended by several authoritative treatment guidelines. Most recently, it was included in the KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV) (Public Review Draft), issued by the kidney disease: Improving Global Outcomes (KDIGO) organization.

About NEFECON(R)

NEFECON(R) 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(R) 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 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 atwww.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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Everest Medicines Announces the Implementation of NEFECON National Reimbursement Drug List Pricing in China for the Treatment for IgA Nephropathy

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