▎WuXi AppTec Content Team Report

Today (March 31), Roche has just announcedOcrelizumab Injection (ocrelizumab injection) has been officially approved by the National Medical Products Administration (NMPA) of China.Administered once every six months via intravenous infusion for the treatment of adult relapsing multiple sclerosis (RMS, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis) and adult primary progressive multiple sclerosis (PPMS).Public information shows that this was developed by Roche.Monoclonal antibody drugs targeting CD20-positive B cells.

Multiple Sclerosis (MS) is a chronic disease, with RRMS (Relapsing-Remitting MS), SPMS (Secondary Progressive MS), and PPMS (Primary Progressive MS).Three Main TypesWhen MS occurs, the immune system abnormally attacks the myelin of nerve cells in the central nervous system, leading to inflammation and damage. This damage may cause a range of symptoms, including muscle weakness, fatigue, and vision difficulties, potentially resulting in disability.。CD20-positive B cells are considered a key factor leading to myelin and nerve cell axon damage, which results in disability for patients with MS.。

Ocrelizumab is a monoclonal antibody drug developed by Roche that targets CD20-positive B cells.This drug can bind to certain B cells expressing the CD20 antigen, inhibiting their function; however, it does not bind to stem cells or plasma cells, thus preserving important functions of the immune system.. Meanwhile, the product is designed as an injectable medication, infused once every six months (i.e.,Only twice a year infusion needed)`, which is expected to significantly improve the compliance of patients with multiple sclerosis.`

According to the Roche press release, results from the two randomized, double-blind, double-dummy, active-controlled Phase III clinical trials, OPERA I and OPERA II, for relapsing multiple sclerosis (RMS) showed that, compared with interferon β-1a treatment,Ocrelizumab can significantly reduce the annual relapse rate (ARR) and the proportion of patients with disability (the proportion of patients with 12-week confirmed disability progression, CDP).。In the pooled analysis of OPERA I/II and individual trials, patients treated with Ocrelizumab consistently showed a significant reduction in the risk of 12-week, 24-week, and 48-week confirmed disability progression (CDP).In terms of safety, the incidence of adverse events was comparable between the ocrelizumab treatment group and the control group.

The results of the ORATORIO randomized, double-blind, placebo-controlled clinical trial for primary progressive multiple sclerosis (PPMS) showed,Compared with the placebo group, patients receiving Ocrelizumab treatment can significantly reduce the 12-week CDP risk by approximately 24%, reaching the primary endpoint. Treatment with Ocrelizumab can reduce the 24-week CDP risk by approximately 25%.; In addition, experimental imaging evidence also demonstrated that patients treated with Ocrelizumab experienced a delay in brain volume loss caused by the disease. In terms of safety, there was no significant difference in the incidence of adverse reactions and serious infections between the Ocrelizumab-treated group and the control group.

Notably, Roche has also developed ocrelizumab.Subcutaneous injection, allowing the drug to be administered twice a year within 10 minutes., helping multiple sclerosis patients spend less time treating the disease.In 2024, Ocrelizumab Subcutaneous Injection was successively approved in the EU and the United States for the treatment of multiple sclerosis and primary progressive multiple sclerosis. The Phase III OCARINA II trial evaluated the efficacy of this subcutaneous injection in treating RMS and PPMS patients.TestPreviously achieved primary and secondary endpoints, confirmed by a 12-week pharmacokinetic review.Compared with Intravenous (IV) Administration, Non-Inferiority Reached, the two have comparable efficacy in controlling lesion activity on patients' brain magnetic resonance imaging (MRI) over 12 weeks.

References:

[1]Twice-Yearly Injection! Roche's Rocatis® Approved in China for Relapsing and Primary Progressive Multiple Sclerosis. Fromhttps://mp.weixin.qq.com/s/Ni8YlqVkBYgan2ibTPVAgw