Roche：Gazyva® Obinutuzumab Granted Priority Review
Roche’s Obinutuzumab Injection (Brand Name: Gazyvaro®/Gazyva®) has been granted priority review by the CDE for the treatment of primary membranous nephropathy (pMN).
In February of this year, Roche announced that the study met its primary endpoint: the proportion of patients achieving sustained complete remission after 104 weeks of obinutuzumab treatment was higher than that with tacrolimus, with a statistically significant and clinically meaningful difference. Obinutuzumab (brand names: Gazyva® in the US / Gazyvaro® in Europe, and Jialuohua in China) is the world’s first humanized, glycoengineered, Type II anti-CD20 monoclonal antibody. Compared with the chimeric murine-human Type I anti-CD20 antibody rituximab, its antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) are enhanced by more than 35-fold.
In June 2021, the drug was approved for marketing by the NMPA in China under the brand name Jialuohua. It is indicated, in combination with chemotherapy, for the initial treatment of adult patients with previously untreated Stage II with bulky disease, Stage III, or Stage IV follicular lymphoma who have achieved at least a partial response, followed by maintenance therapy with obinutuzumab.
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