Everest medicines announces Taiwan TFDA approval of NEFECON® for the treatment of Primary IgA Nephropathy

SHANGHAI , Oct. 21, 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 announces that the Taiwan Food and Drug Administration (TFDA) has approved NEFECON^® indicated "to reduce the loss of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression^[1]". There are no restrictions on initial proteinuria levels in the approved indication. This marks the expansion of NEFECON^®, the world's first and only IgAN etiological treatment drug fully approved by the U.S. Food and Drug Administration (FDA), to more IgAN patients.

"The approval of NEFECON^® in Taiwan, China is another milestone for NEFECON^®, following approvals in Singapore, Hong Kong, and the commercial launch in Mainland China this year." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "IgAN is prevalent in the Asian population, which has 56% higher risk of progression to end-stage renal disease and faster disease progression, indicating a significant unmet clinical demand. In the future, we will continue to expand the access of NEFECON^® across Asia to bring this first-in-disease therapy to more patients."

The global Phase 3 NefIgArd clinical trial 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) (p<0.0001), reducing the decline in kidney function by 50% and potentially delaying the progression to dialysis or kidney transplantation by 12.8 years.

Taiwan, China is the fifth region in Everest Medicines' authorized area to approve NEFECON^® after Macau, Mainland China, Singapore, and Hong Kong. As the core product of Everest Medicines in the field of nephrology, NEFECON^® was also submitted for new drug application in South Korea at the end of 2023 and successfully accepted. In May of this year, the first prescription was issued in Mainland China. In July this year, the China's National Medical Products Administration has accepted the submission of a supplemental new drug application seeking full approval of NEFECON^® based on the complete clinical data from the global Phase 3 NeflgArd study, and NEFECON^® is expected to become the first and only fully approved IgAN etiological treatment drug in China.

In addition, NEFECON^® is expected to be included in the first Chinese IgAN guidelines, recommended as the 1L treatment for IgAN patients at risk of disease progression.