# TQB3616

Source: https://onco.cc/drugs/tqb3616/  
OnCo record `tqb3616` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TQB3616 is an experimental small-molecule drug from Chia Tai Tianqing Pharmaceutical in phase 3 trials for HR-positive / HER2-negative breast cancer, aimed at CDK4/6.

## Summary

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; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Modality: small molecule
- Mechanism: TQB3616 is a novel oral cyclin-dependent kinase (CDK) 4/6 inhibitor used in the treatment of various malignant solid tumours.

## Sources

- ClinicalTrials.gov: trials of TQB3616: https://clinicaltrials.gov/search?intr=TQB3616

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/)
- companies: [Sino Biopharmaceutical (Chia Tai Tianqing)](https://onco.cc/companies/sino-biopharm/)
- trials: [A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer](https://onco.cc/trials/nct06202261/), [Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer](https://onco.cc/trials/nct05780567/), [Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer](https://onco.cc/trials/nct06702618/), [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](https://onco.cc/trials/nct05365178/)

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