Roche's Obinutuzumab Seeks First Non-Oncology Indication Approval in China

Stock News04-03

On April 2, an application for a new indication of Roche Holding Ltd's Obinutuzumab injection was accepted, as indicated on the website of the Center for Drug Evaluation (CDE). Based on the drug's research progress and registration classification, Insight Database speculates that the submitted indication is for the treatment of primary nephrotic syndrome in patients aged two years and above. This specific indication had already been included in the CDE's priority review process in February of this year.

Obinutuzumab is a humanized monoclonal antibody that targets CD20. Outside of China, the drug has already received approval for treating chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and lupus nephritis. In China, Obinutuzumab was first approved in June 2021 for use in combination with chemotherapy for adult patients with follicular lymphoma. In 2025, the global sales revenue for Obinutuzumab reached USD 1.19 billion.

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