InnoCare Pharma has announced that its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).

诺诚健华宣布，其B细胞淋巴瘤-2（BCL2）抑制剂Mesutoclax（ICP-248）获得了中国国家药品监督管理局（NMPA）药品审评中心（CDE）的突破性治疗药物资格（BTD）。

Mesutoclax is an oral BCL2-selective inhibitor being developed as a standalone therapy or in combination with orelabrutinib. Its potential treatment areas include chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), other non-Hodgkin’s lymphomas (NHLs), and acute myeloid leukaemia (AML). .

Mesutoclax是一种口服BCL2选择性抑制剂，正在开发作为单独疗法或与奥拉布替尼联合使用。其潜在治疗领域包括慢性淋巴细胞白血病（CLL）、小淋巴细胞淋巴瘤（SLL）、套细胞淋巴瘤（MCL）、其他非霍奇金淋巴瘤（NHL）以及急性髓系白血病（AML）。

BCL2 plays a key role in controlling cell death, and its abnormal activity is linked to several blood cancers. By blocking BCL2, mesutoclax helps to restore the natural process of cell death in cancer cells.

BCL2在控制细胞死亡方面起关键作用，其异常活动与多种血液癌症有关。通过阻断BCL2，mesutoclax有助于恢复癌细胞的自然死亡过程。

The designation applies to the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL) in patients previously treated with BTK inhibitors. This is the first time a BCL2 inhibitor has been granted BTD status in China.

该指定适用于既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤（R/R MCL）患者的治疗。这是中国首次授予BCL2抑制剂突破性疗法认定（BTD）。

Mesutoclax is currently undergoing clinical trials in China and internationally. These include a Phase III study combining mesutoclax with orelabrutinib as a first-line treatment for CLL/SLL, as well as a study for its use in AML.

目前，美苏托克拉克斯正在中国和国际上进行临床试验。这些试验包括一项将美苏托克拉克斯与奥雷布鲁替尼联合用于CLL/SLL一线治疗的III期研究，以及其在AML中的应用研究。

The Breakthrough Therapy Designation is intended to speed up the development and review of medicines that show clear clinical advantages for serious or life-threatening conditions.

突破性疗法指定旨在加速对显示出针对严重或危及生命状况有明显临床优势的药物的开发和审查。

Source: businesswire.com

来源：businesswire.com