Everest Medicines Launches Nefecon in China

Calliditas Therapeutics AB, a company listed on Nasdaq under the ticker symbols CALT and CALTX, has announced that its partner, Everest Medicines, has launched Nefecon® in China. This development holds substantial promise for the estimated 5 million Chinese patients dealing with IgA nephropathy (IgAN), a progressive autoimmune kidney disease. China has the highest prevalence of primary glomerular diseases globally, with IgAN constituting approximately 35% to 50% of cases. Annually, over 100,000 patients are diagnosed with IgAN through biopsy in China, highlighting a significant need for effective new treatments.

Renee Aguiar-Lucander, the CEO of Calliditas, expressed delight at the culmination of years of dedicated work, allowing Chinese patients to now access Nefecon. This medication is specifically designed to target the root cause of IgAN.

Insights from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial were shared at the American Society of Nephrology Kidney Week in 2023. The findings indicated that Nefecon had a more pronounced effect on the Chinese cohort compared to the global data set in terms of kidney function, proteinuria, and microhaematuria. Notably, the Chinese cohort exhibited a mean absolute change from baseline in the estimated glomerular filtration rate (eGFR) at 24 months, showing a 66% reduction in kidney function loss with Nefecon, compared to a 50% reduction in the global population.

In November 2023, Nefecon® received conditional approval for treating IgAN from China's National Medical Products Administration (NMPA). Beyond China, Nefecon® has been approved and launched commercially in Macau, Hong Kong, and Singapore. It was first prescribed in Macau at the end of the previous year. Furthermore, New Drug Applications (NDA) for Nefecon® were accepted for review in Taiwan and South Korea at the close of 2023.

This recent milestone signifies a major advancement in addressing the unmet medical needs of IgAN patients in China and other Asian regions.