CALT - Calliditas partner Everest plans to seek approval of kidney disease drug Nefecon in China

Calliditas Therapeutics (NASDAQ:CALT) said its partner Everest Medicines plans to submit a new drug application (NDA) for kidney disease drug Nefecon in China in the H2 2022. The company said Everest received breakthrough therapy designation in China in December 2020, and have completed enrollment of the 60 Chinese patients required to complement the submission of a global data set from the NefIgArd trial. Everest plans to conduct an interim analysis of the Chinese patients and this is expected to lead to a regulatory submission in China in H2. "We are excited about the possibility of a significantly earlier potential approval in China, and are happy to support our partner Everest in their endeavors to bring the first approved medicine for IgA nephropathy to Chinese patients," said Calliditas CEO Renée Aguiar-Lucander. Nefecon is used treat IgA Nephropathy, an autoimmune disease that attacks the kidneys. Earlier in March 2022, Calliditas expanded its partnership with Everest for Nefecon to

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Calliditas partner Everest plans to seek approval of kidney disease drug Nefecon in China