The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted by Swiss pharmaceutical giant Roche for its paroxysmal nocturnal hemoglobinuria (PNH) drug, crovalimab, granting it priority review status.
About PNH
PNH is a rare and fatal blood system disease with an incidence of approximately 1 to 10 cases per million population, primarily affecting young adults. Around 77% of patients are aged between 20 and 40. Symptoms include fatigue, anemia, bone marrow failure, hemoglobinuria, and thrombosis. Without treatment, PNH patients face a 35% risk of death within five years. Currently, classical PNH is treated with blood transfusion and symptomatic treatment in China, with no effective therapy targeting the root cause.
Crovalimab Overview
Crovalimab (RG6107) is a monoclonal antibody (mAb) targeting complement inhibitor C5, designed to block the complement system in the human immune system. Developed in-house using continuous monoclonal antibody recovery technology (Smart-Ig) engineering transformation, the drug can block the cleavage of complement C5 into C5a and C5b, inhibiting complement activation. In July of this year, crovalimab was granted priority review status for falling into categories including urgently needed drugs in short supply, innovative drugs, and modified drugs for the prevention and treatment of major infectious diseases and rare diseases; drugs included in the breakthrough therapy program; and drugs that meet conditions for approval.-Fineline Info & Tech
