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Obutiinib 5

Obitinib (trade name: Yinokai) is a highly selective new BTK inhibitor independently developed by Nuo Cheng Jianhua. Obitinib has an innovative compound structure, resulting in high selectivity, reduced off-target effects, and better efficacy and safety. The registered clinical trial of Obrutinib for relapsed/refractory mantle cell lymphoma (MCL) has been completed and the NDA listing application is expected to be submitted to FDA in 2024. MCL is a subtype of B- cell non-Hodgkin lymphoma caused by malignant transformation of B lymphocytes in the follicular mantle region of the lymph node. There is no standard therapy for relapsed/refractory MCL, and the US Food and Drug Administration (FDA)-approved therapies for this patient remain limited, with low rates of complete remission, short duration of remission, and poor safety and tolerability in older patients. Obrutinib for the treatment of relapsed/refractory MCL has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) (Breakthrough Therapy Designation).

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