Drug intelligence / Profile preview

SH3765 + fulvestrant

Development stage
Phase 1
Lead developer
Nanjing Sanhome Pharmaceutical
Modality
Small Molecules
Administration
Oral, Intramuscular
01

Overview

SH3765 + fulvestrant is a combination therapy being developed by Nanjing Sanhome Pharmaceutical for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. SH3765 is an orally bioavailable small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are key regulators of the cell cycle transition from G1 to S phase. Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades the estrogen receptor. The combination aims to overcome endocrine resistance by simultaneously targeting the estrogen receptor pathway and the cell cycle machinery. It is currently being evaluated in Phase Ib clinical trials to assess safety, efficacy, and pharmacokinetics.

02

Targets

ER (Estrogen receptor)CDK4 (Cyclin-dependent kinase 4)CDK6 (Cyclin-dependent kinase 6)

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