Culmerciclib: First Approval

doi:10.1007/s40265-026-02333-x

2026-05-25

PRE

Yahiya Y. Syed *

DOI：10.1007/s40265-026-02333-x

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Culmerciclib（赛坦欣®）是由华北制药天晴制药开发的一种口服小分子CDK2/4/6抑制剂，用于治疗乳腺癌。通过同时抑制CDK2、CDK4和CDK6，Culmerciclib可能有助于克服HR+/HER2−乳腺癌的耐药机制。该药物于2025年12月9日在中国首次获批，用于联合fulvestrant治疗经内分泌治疗后疾病进展的HR+/HER2−成人晚期或转移性乳腺癌。本文总结了Culmerciclib开发过程中导致此次首次获批的关键里程碑。

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