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Culmerciclib + fulvestrant is an orally and intramuscularly administered combination therapy developed for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Culmerciclib (formerly known as TQB3616 or kumociclib) is a novel, orally active, small-molecule inhibitor of cyclin-dependent kinases 2, 4, and 6 (CDK2/4/6) developed by Chia Tai Tianqing and Lianyungang Runzhong Pharmaceutical. By selectively targeting CDK4 and CDK2 while minimizing CDK6 inhibition, culmerciclib is designed to overcome resistance to traditional CDK4/6 inhibitors while maintaining a favorable bone marrow safety profile. Fulvestrant is an intramuscular selective estrogen receptor degrader (SERD) that downregulates estrogen receptor signaling. The combination was first approved in China in December 2025 for second-line treatment of HR+/HER2- advanced breast cancer, and subsequently in May 2026 for first-line treatment.
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