TQB3616

TQB3616 is a small-molecule drug developed by Chia Tai Tianqing Pharmaceutical. Its target is CDK4/6 (the sponsor names CDK4/6). The sponsor states: TQB3616 is a novel oral cyclin-dependent kinase (CDK) 4/6 inhibitor used in the treatment of various malignant solid tumours. ClinicalTrials.gov describes the intervention as: TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. It is the investigational product in 4 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT05780567 (Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer) and NCT05365178 (To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer), in HR-positive / HER2-negative breast cancer. The largest, NCT05780567, plans to enrol 1946 participants with primary completion expected 2026-12. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.