Roche's Obinutuzumab Injection in China Recommended for Priority Review for Primary Membranous Nephropathy

Stock News06-05

On June 4th, the official website of China's Center for Drug Evaluation (CDE) announced that the Obinutuzumab Injection application from Roche Holding Ltd (RHHBY.US) has been recommended for priority review, intended for the treatment of adult patients with primary membranous nephropathy (pMN).

Obinutuzumab injection is a glycoengineered anti-CD20 monoclonal antibody designed to achieve deeper tissue B-cell depletion. CD20 is a protein expressed on certain types of B cells. In China, obinutuzumab was included in the priority review pathway by the CDE this past February for the treatment of primary nephrotic syndrome in patients aged 2 years and older.

In February of this year, Roche announced that its Phase 3 MAJESTY study in adult patients with primary membranous nephropathy had met its primary endpoint. The study results showed that, compared to the active comparator, a significantly greater number of patients treated with obinutuzumab achieved a complete remission at two years (104 weeks), a difference that was both statistically significant and clinically meaningful.

Regarding safety, the findings were consistent with the drug's previously established safety profile, with no new safety signals identified. Analysis of key secondary endpoints also showed positive results, including statistically significant and clinically meaningful improvements for obinutuzumab over the active comparator in the overall response rate (complete or partial remission) at week 104 and the complete remission rate at week 76.

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