On March 18, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022 (Press release, Calliditas Therapeutics, MAR 18, 2022, View Source [SID1234610330]).

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Everest received Breakthrough Therapy Designation (BTD) from the China Center for Drug Evaluation, National Medical Products Administration (CDE,NMPA) in December, 2020 and have completed enrollment of the 60 Chinese patients required to complement the submission of the 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 2H of 2022.

"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 CEO Renée Aguiar-Lucander.

As previously reported, in 2019 Calliditas entered into a license agreement to develop and commercialize NEFECON in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN). In March 2022, Calliditas expanded this partnership to include South Korea.