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源瑞达治疗复发或难治性大B细胞淋巴瘤新适应症的上市许可申请获受理

Genoray's application for marketing approval for the new indication of recurrent or refractory large B-cell lymphoma has been accepted.

Breakings ·  Sep 27 16:43

According to the official WeChat account of vcanbio cell & gene engineering corp.,ltd., on September 26, the website of the Drug Evaluation Center (CDE) of the National Medical Products Administration published information showing that the new indication for the first CAR-T cell therapy product, Yuanruitda (Nagiorlin injection), developed by Henryon Bio-Pharmaceutical Technology (Tianjin) Co., Ltd. (referred to as "Henryon Bio") has been formally accepted for market approval application, with the acceptance number CXSS2400104, for the treatment of relapsed or refractory Large B-Cell Lymphoma (r/r LBCL) that has relapsed after second-line or above systemic therapy. This is the second indication in China for Yuanruitda after the submission of a new drug marketing application for relapsed or refractory B-cell Acute Lymphoblastic Leukemia in adults (r/r B-ALL).

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