China is first country to approve crovalimab for PNH

Crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Japan’s Chugai Pharmaceutical (TYO: 4519), has been approved by China’s National Medical Products Administration (NMPA) for treatment of adults and adolescents (12 years and above) with paroxysmal nocturnal hemoglobinuria (PNH) not been previously treated with complement inhibitors.

Swiss pharma giant Roche (ROG: SIX), the majority shareholder of Chugai, is responsible for the development of crovalimab outside Japan and Taiwan, the regulatory application was filed by a China affiliate of Roche. China is the first country in the world to approve crovalimab, noted Chugai.

The approval is based on the results of several studies including COMMODORE 3 study, a multicenter, single-arm, Phase III clinical trial conducted in China, and COMMODORE 2 study, a randomised, open-label global Phase III study, for PNH without history of complement inhibitor treatment.