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诺诚健华:自研新型BCL2抑制剂Mesutoclax联合奥布替尼一线治疗CLL/SLL的注册性III期临床试验完成患者入组
Zhong Zheng Wang· 2026-02-26 09:58
Core Viewpoint - The company announced the completion of patient enrollment for a pivotal Phase III clinical trial of its novel BCL2 inhibitor Mesutoclax (ICP-248) in combination with the BTK inhibitor Acalabrutinib for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [1] Group 1: Product Development - Mesutoclax is a novel oral, highly selective BCL2 inhibitor that targets the BCL2 protein, which is crucial in regulating apoptosis and is associated with the development of various malignant hematological tumors [1] - The mechanism of Mesutoclax involves selectively inhibiting the BCL2 protein to restore apoptosis in tumor cells, thereby inhibiting tumor growth and spread [1] - The combination of Mesutoclax with Acalabrutinib aims to provide deeper remission for first-line CLL/SLL patients and prevent the emergence of resistance mutations [1] Group 2: Clinical Trials and Approvals - In addition to first-line treatment for CLL/SLL, Mesutoclax is advancing towards registration clinical trials for treating mantle cell lymphoma after resistance to BTK inhibitors, having received its first breakthrough therapy designation [1] - Clinical research for Mesutoclax in treating acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) is also progressing [1]