Recently, the Crovalimab Injection (trade name: 派圣凯/Piasky) of Roche Pharma (Schweiz) AG was approved for marketing by China NMPA through the priority review and approval procedures. It is indicated for use in adults and adolescents (≥12 years old) with paroxysmal nocturnal hemoglobinuria who have not received complement inhibitor therapy.

The paroxysmal nocturnal hemoglobinuria (PNH) is a chronic intravascular hemolysis caused by blood cell membrane defect attributable to acquired hematopoietic stem cell gene mutations, which is often worsened during sleep, and can be accompanied by episodic hemoglobinuria, potential bone marrow failure, and thrombosis. The PNH has been included in the first batch of the rare diseases catalogue in China. The Crovalimab Injection is a recombinant humanized IgG1 subtype monoclonal antibody targeting complement protein C5. It can specifically bind to complement protein C5, thereby inhibiting C5 cleavage into C5a and C5b, preventing the production of terminal complement complex C5b-9, and therefore inhibiting the immune response of complement pathway. This drug variety has been in simultaneous global research and development and it is firstly approved for marketing in China, which provides new treatment options for patients.