NEFECON Included in 2024 KDIGO Clinical Practice Guidelines

October 01, 2024 at 21:18 PM EDT

HONG KONG, Oct 2, 2024 - (ACN Newswire) - Recently, Everest Medicines has announced another positive development. The company’s lead product, NEFECON, as the only in-disease IgA nephropathy (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)” (hereinafter referred to as the “New Guidelines (Draft)”), recommending treatment with a 9-month course of NEFECON for patients who are at risk of progressive kidney function loss with IgAN (2B). This significant milestone further solidifies Everest Medicines' leadership in the treatment of IgAN and brings new hope to IgAN patients worldwide.

NEFECON Ushering in a New Era of Standardized Treatment of IgA Nephropathy

According to the New Guidelines, NEFECON is the only treatment to date proven to reduce levels of pathogenic forms of IgA and IgA immune complexes. The inclusion of NEFECON in the New Guidelines Draft solidifies NEFECON as the first-line cornerstone in the treatment of IgAN, ushering in a new era of standardized treatment. With the imminent release of China’s first-ever IgAN guidelines, NEFECON is expected to be recommended as the first-line treatment for IgAN patients at risk of disease progression, further reinforcing its pivotal role in clinical practice.

According to Everest Medicines’ recent financial reports, NEFECON has generated RMB 167.3 million in sales revenue just over a month after its commercial launch and first prescription in mainland China in May 2024, demonstrating strong market demand. NEFECON has been commercially launched in mainland China, Macau, and Singapore, and has also been approved in Hong Kong. The New Drug Application (NDA) of NEFECON has been accepted in South Korea, signaling steady progress in global commercialization.

In the second half of 2024, Everest Medicines will continue to promote the sales of NEFECON in mainland China and other regions in the Asia-Pacific, while actively participating in China’s National Reimbursement Drug List (NRDL) negotiations to further enhance the affordability and accessibility. It is expected that 2025 will be a breakout year for NEFECON sales, with promising potential for the future.

Core Products Performing Strongly, Differentiated Pipeline Further Refined

According to Everest Medicines’ interim results for the first half of 2024, the company’s total revenue reached RMB 301.5 million, marking a significant growth of 158% compared to the second half of 2023, and achieved commercial level profitability. The commercial launch of NEFECON has been a key driver behind this revenue growth. In addition, XERAVA (eravacycline), the world’s first-in-class fluorocycline antibiotic, also performed exceptionally well, generating RMB 134.2 million in sales in the first half of 2024. As the availability of XERAVA expands to reach more patients, its revenue is expected to grow further.

Within the autoimmune disease portfolio, the lead product VELSIPITY (etrasimod) has been approved in Macau and Singapore, with plans to submit a New Drug Application (NDA) in mainland China and Hong Kong in the second half of 2024, alongside a commercial launch in Macau. Everest Medicines is expected to have three commercialized products by the end of 2024, further refining its differentiated pipeline development and driving the company into a new phase of growth.

In terms of innovative R&D, Everest Medicines owns a proprietary mRNA development platform with full intellectual property and global rights, focusing on developing both preventive and therapeutic self-developed mRNA products. In August 2024, Everest announced the launch of the first-in-human Investigator-Initiated Clinical Trial (IIT) for EVM16, a personalized mRNA cancer vaccine program. Everest Medicines is anticipated to submit investigational new drug applications in the United States and China in 2025 for EVM14, a Tumor-Associated Antigens (TAA) cancer vaccine program.

In addition, EVER001, a next-generation covalent reversible BTK inhibitor, with global rights, is under development for the treatment of renal diseases worldwide. The company is expected to announce the topline results of its Phase 1b study in membranous nephropathy in the second half of 2024.

With the company’s dual-engine strategy of in-house discovery and global in-licensing, Everest Medicines continues to expand its product pipeline and drive business growth. The company maintains its revenue guidance of RMB 700 million for 2024 and remains confident in achieving cash flow break-even by the end of 2025.

With NEFECON being included in multiple authoritative domestic and international treatment guidelines, along with the ongoing R&D and promotion of numerous core products. Everest Medicines has once again demonstrated its leading position in the global biopharmaceutical field. Armed with its robust pipeline and continuous innovative R&D capabilities, the company is steadily advancing towards becoming a top-tier player in the global pharmaceutical industry.