New Drug Application Approval by the Pharmaceutical Administration Bureau of Macau for Nefecon® for the Treatment of Primary IgA Nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that its commercial partner Everest Medicines (HKEX 1952.HK) (“Everest”) received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China.  The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Macau is the first region in Everest territories that received Nefecon approval.

The NDA for Nefecon in mainland China is under Priority Review and Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China. Nefecon has been available for clinical use in Shanghai Ruijin Hospital’s Hainan subsidiary through an early-access program since April 2023.