Roche's Next-generation C5 Complement Inhibitor Crovalimab Successfully Completed Phase III Study in China

On May 23, Roche announced that its innovative drug crovalimab has achieved positive results in a phase III clinical study (COMMDORE 3) for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), which is based on lactate dehydrogenase (LDH). The mean proportion of hemolytic control measured at ) levels and the proportion of patients who avoided transfusion (TA) met the co-primary endpoints.

COMMODORE 3 is a multicenter, single-arm Phase III clinical study conducted only in China to evaluate crovalimab in Chinese patients with PNH who have not received prior complement inhibitor therapy. Detailed results will be presented at an upcoming medical meeting.

PNH is a rare and fatal blood system disease, with an incidence of about 1 to 10 cases per million population, mostly young adults, and about 77% of patients aged 20-40. Without treatment, patients have a 35 percent risk of death within five years. At present, blood transfusion and symptomatic treatment are the mainstays of classical PNH in China, and there is still no effective treatment for the cause of the disease.

Crovalimab is a new generation of C5 inhibitor independently developed by Roche through continuous monoclonal antibody recovery technology (Smart-Ig) engineering. It can block the cleavage of complement C5 into C5a and C5b, and is expected to inhibit complement activation. Complement is part of the body's innate immune system, and complement activation is responsible for many diseases.