Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria

The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche (SWX: ROG) for Piasky (crovalimab) under priority review status. This approval is specifically for the treatment of adult and adolescent patients aged 12 and older with paroxysmal nocturnal hemoglobinuria who have not previously received treatment with a complement inhibitor.

Crovalimab is a recombinant humanized IgG1 monoclonal antibody that targets complement protein C5. By specifically binding to C5, it inhibits its cleavage into C5a and C5b, thereby preventing the formation of the terminal complement complex C5b-9 and modulating the complement pathway immune response. Developed through a coordinated global effort, crovalimab marks a significant milestone as it becomes the first of its kind approved in China.- Flcube.com

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