智通财经APP讯，诺诚健华(09969)发布公告，国家药品监督管理局(NMPA)药品审评中心(CDE)已批准在中国进行B细胞淋巴瘤-2 (BCL2)抑制剂ICP-248 (Mesutoclax)联合 BTK抑制剂奥布替尼治疗一线慢性淋巴细胞白血病(CLL) ╱小淋巴细胞淋巴瘤 (SLL)患者的注册III期临床试验。
ICP-248 (Mesutoclax)是一款新型口服高选择性BCL2抑制剂，BCL2是细胞凋亡通路的重要调控蛋白，其表达异常与多种恶性血液肿瘤的发生发展相关。ICP248 (Mesutoclax)通过选择性抑制BCL2蛋白，恢复肿瘤细胞正常凋亡，从而抑制肿瘤活性。ICP-248 (Mesutoclax)与奥布替尼固定疗程联合使用，将为初治CLL/ SLL患者提供更深层次的缓解，并避免产生耐药突变，为初治CLL/SLL患者带来临床治愈希望，成为一种潜力巨大的治疗方案。
ICP-248 (Mesutoclax)联合奥布替尼治疗初治CLL/SLL患者在Ⅱ期临床试验中观察到良好的疗效和安全性，联合疗法上市将为初治CLL/SLL患者提供更佳治疗选择。
公司正在全球范围内迅速推进ICP-248 (Mesutoclax)的多项临床试验，包括治疗非霍奇金淋巴瘤(NHL)及急性髓性白血病(AML)。集团的血液肿瘤在研药物旨在实现强大的协同作用，特别是BTK抑制剂与BCL2抑制剂联用，有望为患者带来更大获益。
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