Calliditas Therapeutics

China, which is estimated to have up to 5 million patients suffering from the progressive autoimmune disease, IgA nephropathy (IgAN), has the highest prevalence of primary glomerular diseases in the world, with IgAN accounting for about 35% to 50% of cases with a biopsy proven incidence of over 100,000 patients per year. There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.

"This is a fantastic result from many years of dedication and hard work by teams from both companies and I am delighted that patients in China now can benefit from Nefecon, which has been specifically designed to address the origin of IgAN," said Renee Aguiar-Lucander, CEO.

Results from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week in 2023, provided evidence that the treatment effect of Nefecon in the Chinese cohort was greater than in the global data set with regards to kidney function, proteinuria and microhaematuria. In the Chinese cohort, the mean absolute change from baseline in estimated glomerular filtration rate (eGFR) at 24 months showed an approximately 66% reduction in loss of kidney function with Nefecon over the period, compared with a 50% reduction in loss of eGFR in the global data set.

Nefecon® was awarded conditional approval in IgAN by China's National Medical Products Administration (NMPA) in November 2023. In addition to being approved and commercially launched in Mainland China, Nefecon® has also received approval in Macau, Hong Kong and Singapore, and was successfully commercially launched and first prescribed in Macau at the end of last year.  New Drug Applications (NDA) for Nefecon® were also successfully accepted for review in Taiwan and South Korea at the end of 2023.