By Fineline Cube 
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its selective immunosuppressant Ocrevus (ocrelizumab). The drug is approved for the treatment of adults with recurrent multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis, as well as adult primary progressive multiple sclerosis (PPMS). Ocrevus is administered via intravenous infusion every six months.
Global Approval and Mechanism
Ocrevus, a CD20-targeted antibody, is already approved in over 100 countries and regions. It works by targeting CD20-positive B cells, which play a key role in the pathogenesis of multiple sclerosis.
Clinical Trial Results
- OPERA I and OPERA II Studies (RMS): These randomized, double-blind, active-controlled Phase III trials demonstrated that Ocrevus significantly reduced the annualized relapse rate (ARR) and the proportion of patients with confirmed disability progression (CDP) at 12 weeks compared to interferon beta-1a.
- ORATORIO Study (PPMS): This randomized, double-blind, placebo-controlled Phase III trial showed that Ocrevus significantly reduced the risk of confirmed disability progression (CDP) by approximately 24% at 12 weeks compared to placebo, meeting the study’s primary endpoint.-Fineline Info & Tech