NMPA approves AiRuiKang® (dalpiciclib) in combination with fulvestrant for the treatment of relapsed/progressed HR+/HER2- advanced breast cancer

January 3, 2021 (Shanghai, China) – The National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for dalpiciclib (Hengrui’s CDK4/6 inhibitor) in combination with fulvestrant for the treatment of relapsed/progressed HR+/HER2- advanced breast cancer. Dalpiciclib is the first domestically developed CDK4/6 inhibitor that gained marketing approval in China. It is designed without the 1,4 p-phenylenediamine structure to avoid glutathione trapping. Previous research demonstrated that the accumulation of glutathione adduct is associated with hepatotoxicity.1

This approval is based on the interim data of a Phase III study (DAWNA-1, NCT03927456), which demonstrated that dalpiciclib in combination with fulvestrant significantly prolonged progression-free survival (PFS), with a promising safety profile consistent with the molecular design and earlier clinical studies of dalpiciclib. The data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and published in Nature Medicine in 2021.

  • The primary endpoint of PFS was met at the interim analysis:
    • The median PFS was 15.7 months (95% CI = 11.1–not reached) in the dalpiciclib plus fulvestrant group versus 7.2 months (95% CI = 5.6–9.2) in the placebo plus fulvestrant group.2
    • Dalpiciclib plus fulvestrant reduced the risk of disease progression or death by 58% (HR = 0.42, 95% CI = 0.31–0.58, one-sided P < 0.0001).2
  • The incidence of increased ALT was numerically lower in the dalpiciclib plus fulvestrant group compared with the placebo plus fulvestrant group (all grades: 15.0% vs. 26.7%; Grade 3: 0 vs. 0.8%; Grade 4: 0 vs. 0.8%).2 In addition, gastrointestinal toxicity, a common adverse effect of abemaciclib, was rarely observed with dalpiciclib.2, 3
  • The incidence of serious adverse events was comparable between dalpiciclib plus fulvestrant and placebo plus fulvestrant groups (5.8% vs. 6.7%); the number of patients who discontinued any treatment component due to AEs was 6 (2.5%) and 4 (3.3%), respectively.
  •  The median time to first subsequent chemotherapy or death was not reached in the dalpiciclib plus fulvestrant group versus 14.2 months (95% CI = 9.7–not reached) in the placebo plus fulvestrant group (HR = 0.47, 95% CI = 0.32–0.69; one-sided P < 0.0001).2

About the DAWNA-1 Study

DAWNA-1 (NCT03927456) is a Phase 3, double-blind, randomized study, which enrolled 361?patients with HR+/HER2- locally advanced or metastatic breast cancer who had relapsed or progressed on prior endocrine therapy. Patients were randomized 2:1 to receive either dalpiciclib plus fulvestrant or placebo plus fulvestrant. The primary endpoint is investigator-assessed PFS. The secondary endpoints include overall survival, PFS per IRC, objective response rate, clinical benefit rate, duration of response, time to response, time to first subsequent chemotherapy or death, time to second objective disease progression (defined as the time from randomization to discontinuation of next-line treatment or tumor progression on next-line treatment or death), and safety.

About HR+/HER2- Breast Cancer

HR+/HER2- breast cancer is the most common molecular subtype of breast cancer, accounting for around 70% of all cases.4, 5 The incidence of HR+/HER2- breast cancer varies by ethnicity/race with White women having the highest incidence rate (91.3 out of 100,000).4

About Dalpiciclib

Dalpiciclib is a novel, orally-administered, selective CDK4/6 inhibitor developed by Hengrui. Dalpiciclib has been investigated in over ten clinical studies, including 1st line (NCT03966898) and ≥2nd line (NCT03927456) treatment of HR+/HER2- advanced breast cancer, and adjuvant therapy (NCT04842617) of HR+/HER2- early-stage breast cancer. In April 2021, NMPA granted dalpiciclib Breakthrough Therapy Designation and Priority Review of the NDA for the treatment of HR+/HER2- locally advanced or metastatic breast cancer. This NDA got approved within around 8 months.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company based in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 24th among the top 1,000 global pharma companies in 2021.6 Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

1. Reese M, Sakatis M, Ambroso J, Harrell A, et al. An integrated reactive metabolite evaluation approach to assess and reduce safety risk during drug discovery and development. Chem Biol Interact. 2011 Jun 30;192(1-2):60-4. doi: 10.1016/j.cbi.2010.10.005. Epub 2010 Oct 21. PMID: 20970409.

2. Xu B, Zhang Q, Zhang P, et al. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med (2021).

3. Sledge, G. W. Jr. et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy––MONARCH 2: a randomized clinical trial. JAMA Oncol. 6, 116–124 (2020).

4. National Cancer Institute, Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Female Breast Cancer Subtypes. Available:?

5. Waks AG, Winer EP. Breast Cancer Treatment: A Review. JAMA. 2019 Jan 22;321(3):288-300. doi: 10.1001/jama.2018.19323. PMID: 30667505.


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