2月17日,诺诚健华(688428/09969)发布公告,近日公司自主研发的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/小淋巴细胞淋巴瘤(CLL/SLL)已获得国家药品监督管理局(NMPA)药品审评中心(CDE)的批准,启动注册性III期临床试验。
该药物是一款新型口服高选择性BCL2抑制剂,旨在通过恢复肿瘤细胞凋亡来抑制肿瘤生长和扩散。ICP-248(Mesutoclax)与奥布替尼的联合使用预计将为一线CLL/SLL患者提供更深层次的缓解,并有望避免耐药突变的产生。公司在Ⅱ期临床试验中已观察到该联合疗法的良好疗效和安全性,快速上市将为患者提供更好的治疗选择。尽管此次临床试验批准不会对公司当前业绩产生重大影响,但公司将继续关注该项目的后续进展并及时披露相关信息。
2024年前三季度,诺诚健华实现收入6.98亿元,归母净利润-2.75亿元。
(文章来源:财中社)
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