Roche (RHHBY.US) submitted the first non-tumor indication application for "Osimertinib Monoclonal Antibody" in China.

On April 2nd, the official website of China's Center for Drug Evaluation (CDE) announced that a new indication for Roche's obinutuzumab injection has been accepted for market application. Based on the drug's research progress and registration classification, the Insight database speculates that the indication being applied for this time is for the treatment of primary nephrotic syndrome patients aged 2 and above. In February of this year, this indication was already included in the priority review by the CDE. Obinutuzumab is a humanized monoclonal antibody targeting CD20. Overseas, the drug has been approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and lupus nephritis. In China, obinutuzumab was first approved for marketing in June 2021 for use in combination with chemotherapy for adult patients with follicular lymphoma. In 2025, obinutuzumab's global sales amounted to 1.19 billion US dollars. Screenshot source: CDE official website