Everest Medicines Announces NEFECON®, the World's First Approved Treatment for IgA Nephropathy, is Included in China's National Reimbursement Drug List
SHANGHAI, Nov. 28, 2024 /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 that NEFECON® has been included in the National Reimbursement Drug List ("NRDL"). The 2024 NRDL will take effect starting from January 1st, 2025.
"NEFECON®'s inclusion in the NRDL acknowledges its significant clinical value in improving patient care." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, "With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. We believe that with NEFECON®'s inclusion in the NRDL, more patients with IgAN in China will have access to this innovative treatment and benefit from it. Moving forward, we will proactively collaborate with the government departments for the implementation of medical insurance policies, to benefit more Chinese IgAN patients and their families."
"I am excited to see NEFECON®'s inclusion in the NRDL. IgAN is highly prevalent in China and is one of the main causes of kidney failure in young adults. Compared to European and American populations, Chinese IgAN patients experience faster disease progression, poorer prognosis, and impose a heavy burden on patients and society." Said Professor Chen Nan, Director of the Department of Nephrology at Ruijin Hospital-Shanghai Jiao Tong University School of Medicine, Level II Professor and Doctoral Supervisor at Shanghai Jiao Tong University, Tenure Professor at Ruijin Hospital-Shanghai Jiao Tong University School of Medicine, Director of the Clinical Nephrology Committee of the Chinese Medicine Education Association, "As the first and only approved etiological treatment for IgAN in China, NEFECON® has been providing benefits to IgAN patients since its approval. Under the medical insurance policies, we expect more patients with IgAN can benefit from early etiological treatment to help with disease management and embrace a better life."
Results from Phase 3 clinical study NefIgArd of the Chinese population shows that NEFECON® 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 benefit, NEFECON® has been recommended by multiple domestic and international treatment guidelines, further established its first-line cornerstone position in IgAN treatment.
NEFECON® has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong, Taiwan, China, South Korea and in Singapore under the trade name Nefegan®.
NEFECON® was first approved in December 2021 by the United States FDA under the trade name TARPEYO® and was in 2022 approved by the European Commission and in 2023 by the MHRA, United Kingdom under the trade name Kinpeygo®. The product is marketed in the US by Calliditas Therapeutics AB and in Europe by Calliditas' commercial partner, STADA Arzneimittel AG.
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 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.
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