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诺诚健华(688428.SH):国家药品监督管理局受理tafasitamab联合来那度胺治疗复发或难治性弥漫性大B细胞淋巴瘤的生物制品许可

Innocare (688428.SH): The National Medical Products Administration has accepted the biological product license of tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

Gelonghui Finance ·  Jun 20 19:28

Innovative drug tafasitamab, in combination with lenalidomide, has been licensed for biological product to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not suitable for autologous stem cell transplantation (ASCT). It has been accepted for priority review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA).

Tafasitamab is a humanized monoclonal antibody targeting CD19 with an optimized Fc domain structure. Tafasitamab contains XmAb (Xencor, Inc.'s registered trademark) engineered Fc domain, which mediates B-cell tumour lysis through mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

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