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China NMPA’s approves Calliditas’ Nefecon

Renee Aguiar-Lucander

Calliditas’ partner Everest Medicines has announced that China’s National Medical Products Administration (NMPA) has approved Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

Everest also announced that, in addition to Nefecon’s approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.

“We are very excited about Nefecon’s approval in China. There is clearly a very significant need amongst IgAN patients in China to have access to an approved medication specifically designed to target the origin of the disease and which provides hope of disease modification,” says CEO Renée Aguiar-Lucander.

The Phase 3 NefIgArd trial

Results from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week 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 microhematuria, states the company. In the Chinese cohort, the mean absolute change from baseline in eGFR at 24 months showed an approximately 66% reduction in loss of this measure of kidney function with Nefecon compared with a 50% reduction in loss of eGFR in the global data set.

A milestone payment of five million USD to Calliditas.”

This approval triggers a milestone payment of five million USD to Calliditas, which will be included as revenue in the fourth quarter.

Photo of Renée Aguiar-Lucander: Calliditas