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<p>Culmerciclib (赛坦欣<sup>®</sup>) is an oral, small molecule CDK2/4/6 inhibitor developed by Chia Tai Tianqing Pharmaceutical for the treatment of breast cancer. By simultaneously inhibiting CDK2, CDK4 and CDK6, culmerciclib may help overcome resistance mechanisms in HR+/HER2− breast cancer. The drug received its first approval in China on 9 December 2025 for use in combination with fulvestrant in adults with HR+/HER2− advanced or metastatic breast cancer whose disease has progressed after endocrine therapy. This article summarizes the milestones in the development of culmerciclib leading to this first approval.</p>

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Culmerciclib: First Approval

  • 期刊论文

  • 发表日期：

    2026年5月25日

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  • Yahiya Y. Syed

摘要

Culmerciclib (赛坦欣®) is an oral, small molecule CDK2/4/6 inhibitor developed by Chia Tai Tianqing Pharmaceutical for the treatment of breast cancer. By simultaneously inhibiting CDK2, CDK4 and CDK6, culmerciclib may help overcome resistance mechanisms in HR+/HER2− breast cancer. The drug received its first approval in China on 9 December 2025 for use in combination with fulvestrant in adults with HR+/HER2− advanced or metastatic breast cancer whose disease has progressed after endocrine therapy. This article summarizes the milestones in the development of culmerciclib leading to this first approval.