- Marking Another Milestone in Commercialization
Today, Everest Medicines announced that NEFECON(R) has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). This approval further expands NEFECON(R)’s footprint in Asia and provides Asian patients with a groundbreaking etiological treatment option for IgAN.
Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, expressed his excitement about the approval: “As the world’s first and only IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA), NEFECON(R) will provide a new treatment option for patients in South Korea. We will continue to work on enhancing the accessibility and affordability of NEFECON(R) across Asia to meet the urgent needs of more IgAN patients for this innovative therapy.”
NEFECON(R) is the first and only fully approved etiological treatment for IgAN, with its clinical value widely recognized by the global medical community. The approval of NEFECON(R) in South Korea is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, NEFECON(R) not only brought about a sustained reduction in proteinuria and reduced the frequency of microscopic hematuria but also demonstrated clinically relevant and statistically significant treatment benefits in estimated glomerular filtration rate (eGFR). The study further revealed that NEFECON(R) reduces the decline in kidney function by 50%, over a period of 2 years, comprising 9 months of treatment and 15 months of observation, and potentially delay the progression to dialysis or kidney transplantation by 12.8 years.
Studies have shown that IgAN is highly prevalent among Asian populations, with a 56% higher risk of progression to end-stage renal disease compared to other groups, and often progresses more rapidly. The approval of NEFECON(R) in South Korea provides a breakthrough treatment option for IgAN patients in Asia and highlights its significant commercial potential in the region.
This milestone is further evidence of Everest Medicines’ robust global commercialization capabilities. Earlier this year, NEFECON(R) issued its first prescription in mainland China, with subsequent approvals in Macau, Hong Kong, Singapore (marketed as Nefegan(R)), and Taiwan China. According to the company’s interim report, NEFECON(R) achieved RMB 167.3 million in sales within just over a month of its commercial launch in China, demonstrating strong market performance. The approval in South Korea further validates NEFECON(R)’s clinical value and commercial potential, opening new market opportunities and creating an important revenue growth driver for the company.
Notably, NEFECON(R) participated in China’s National Reimbursement Drug List (NRDL) negotiations this year for the first time. Inclusion in the NRDL would significantly enhance its market penetration and affordability, accelerating its sales growth in China. Industry experts widely view NEFECON(R) as a potential blockbuster drug in the Chinese market, with the ability to drive Everest Medicines’ commercialization strategy while strengthening its competitive edge in both domestic and international markets.