Updated regulatory plans for NEFECON in China
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022.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