# Dalpiciclib

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

## TL;DR

Dalpiciclib is Hengrui's CDK4/6 inhibitor, the first China-developed drug of the class, approved for hormone-driven advanced breast cancer on the DAWNA trials.

## Summary

DAWNA-1 (361 patients, Nature Medicine 2021) showed median progression-free survival of 15.7 versus 7.2 months when dalpiciclib was added to fulvestrant after endocrine therapy (hazard ratio 0.42), the basis of NMPA approval in December 2021; DAWNA-2 with an aromatase inhibitor in the first line followed in 2023. Neutropenia is frequent, as with palbociclib. It gives Chinese patients a reimbursed domestic alternative to imported CDK4/6 inhibitors.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: china
- Brand: Airuikang
- Code: SHR6390
- Modality: Small-molecule CDK4/6 inhibitor
- Mechanism: Selective inhibitor of cyclin-dependent kinases 4 and 6, preventing RB phosphorylation and G1 to S progression in hormone receptor-positive breast cancer.
- Approvals: China 2021: HR-positive, HER2-negative advanced breast cancer with fulvestrant after endocrine therapy (DAWNA-1); China 2023: First-line HR-positive, HER2-negative advanced breast cancer with an aromatase inhibitor (DAWNA-2)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Dalpiciclib
- Jiangsu Hengrui Pharmaceuticals: https://www.hengrui.com/en/
- DAWNA-1 (Nat Med 2021): https://doi.org/10.1038/s41591-021-01562-9
- NMPA (National Medical Products Administration): https://www.nmpa.gov.cn

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [CDK4/6 inhibitors](https://onco.cc/technologies/cdk46-inhibitor/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/)
- companies: [Jiangsu Hengrui Pharmaceuticals](https://onco.cc/companies/hengrui/)
- pathways: [p53 / RB / cell-cycle checkpoint](https://onco.cc/pathways/p53-cell-cycle/)
- trials: [A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors](https://onco.cc/trials/nct06208410/), [Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer](https://onco.cc/trials/nct06167694/), [DAWNA-1](https://onco.cc/trials/dawna-1/), [Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer](https://onco.cc/trials/nct05463601/), [Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Ne](https://onco.cc/trials/nct04842617/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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