On November 28, the National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security announced the inclusion of NEFECON® in the "National Reimbursement Drug List (2024)" (NRDL), effective January 1, 2025. This decision marks a significant advancement in the treatment of IgA nephropathy (IgAN) in China, offering improved access and affordability to millions of patients. NEFECON®, developed by Everest Medicines, is the first etiological treatment for IgAN to be included in the NRDL.
Clinical Validation and Guidelines
NEFECON® has received full approval from the U.S. Food and Drug Administration (FDA) and breakthrough therapy designation in China by the China National Medical Products Administration (NMPA). Data presented at the 2024 American Society of Nephrology (ASN) Annual Meeting from the open-label extension (OLE) phase of the NefIgArd Phase 3 trial showed that patients undergoing a second course of NEFECON® treatment experienced similar benefits in estimated glomerular filtration rate (eGFR) preservation and proteinuria reduction as observed after the initial treatment, with good tolerance. These findings align with recommendations from the "KDIGO 2024 Clinical Practice Guideline for The Management Of Immunoglobulin A Nephropathy (IgAN) And Immunoglobulin A Vasculitis (IgAV)". NEFECON® is also the only treatment proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes.
Market Impact and Unmet Needs
IgAN is highly prevalent in Asia and is a leading cause of kidney failure in young adults in China. With approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand. Since its first prescription in Mainland China in May 2024, NEFECON® has demonstrated strong market performance, achieving RMB1.673 billion in sales within its first month.
Everest Medicines' Portfolio Expansion
In addition to NEFECON®, Everest Medicines' portfolio includes XERAVA® (eravacycline) for complicated intra-abdominal infections, which demonstrated an overall treatment effectiveness rate of 90.1% in a recent comprehensive evaluation project. As of the first half of 2024, XERAVA® achieved cumulative sales of RMB2.33 billion. VELSIPITY®, for autoimmune diseases, has also made progress, receiving approval for use in the Greater Bay Area under the "Hong Kong and Macau Medicine and Equipment Connect" policy and is now available for use in three designated medical institutions within the Greater Bay Area. Everest Medicines has submitted a new drug application (NDA) for VELSIPITY® in Hong Kong and plans to submit an NDA in Mainland China by the end of the year.
Innovation in R&D
Everest Medicines' proprietary mRNA development platform is now fully localized. The company's first personalized mRNA cancer vaccine, EVM16, has initiated an Investigator-Initiated Clinical Trial (IIT). Additionally, EVER001, a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor being developed globally for the treatment of renal diseases, marks another important advancement. Everest Medicines will host an investor call on December 4th to discuss the results of the Phase 1b/2a clinical study of EVER001 in primary membranous nephropathy.
