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 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). The approval of NEFECON^® in South Korea further expands its reach across Asia, bringing new hope to more patients in the region suffering from IgAN.

"As the world's first and only IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA), NEFECON^® will provide a new treatment option for patients in South Korea." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines." 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. We will continue to work on enhancing the accessibility and affordability of NEFECON^® across Asia to meet the urgent needs of more IgAN patients for this innovative therapy."

The approval of NEFECON^® in South Korea is based on the global Phase 3 NefIgArd clinical trial, which showed that compared to placebo, NEFECON^® 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), reducing 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 delaying the progression to dialysis or kidney transplantation by 12.8 years.

Additionally, the complete 2-year data of the NefIgArd study further analyzed the potential differences in the response to NEFECON^® treatment between Asians (n=83) and Caucasians (n=275). The results showed that compared to placebo, treatment with NEFECON^® for 9 months in both Asians and Caucasians can significantly delay the decline of eGFR, protect kidney function, and bring about a sustained reduction in proteinuria and reduce the risk of microscopic hematuria.

NEFECON^® has been prescribed in mainland China since May this year and has been approved in Macau, Hong Kong and Taiwan, and in Singapore under the trade name Nefegan^®. In July this year, the National Medical Products Administration in China officially accepted the supplementary application for the complete data of the final clinical trial stage of NEFECON^®, and NEFECON^® is expected to become the first and only fully approved etiological treatment for IgAN in China.