CALT - Calliditas wins priority review in China for kidney disease drug

• Swedish biopharma Calliditas Therapeutics ( NASDAQ: CALT ) announced Friday that regulators in China recommended the priority review for its marketing application seeking approval of kidney disorder therapy Nefecon.
• In November, Calliditas ( CALT ) announced that China's National Medical Products Administration (NMPA) accepted its partner Everest Medicines' New Drug Application ("NDA") for Nefecon, targeted at certain adults with primary immunoglobulin A nephropathy (IgAN).
• The Center for Drug Evaluation (CDE) has also recommended the priority review for the NDA, which, according to Rogers Luo, the Chief Executive of Everest, could speed up its decision expected in H2 2023.
• In 2019, Calliditas ( CALT ) and Everest signed a licensing agreement to develop and commercialize Nefecon in Greater China and Singapore, targeting IgA Nephropathy. This year, the companies agreed to expand the covered territory to include South Korea.

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