ShanghaiJune 22, 2026 /PRNewswire/ — Recently, China’s first domestically developed CDK4/6 inhibitor, Dalpiciclib (Ailijian®), received official approval from the National Medical Products Administration for use in combination with endocrine therapy as adjuvant treatment for early breast cancer patients with HR+/HER2- and high risk of recurrence. This marks the successful expansion of China’s homegrown CDK4/6 inhibitor from advanced-stage treatment to early adjuvant therapy, filling a gap in this field for domestically developed drugs and offering a new option tailored to the clinical needs of Chinese patients with HR+/HER2- early high-risk breast cancer.
Hengrui’s innovative CDK4/6 inhibitor Dalpiciclib receives new indication approval for adjuvant treatment of HR+/HER2- early breast cancer with high recurrence risk
HR+/HER2- is the most common molecular subtype of breast cancer, accounting for nearly 70% of all cases. Even after standard postoperative adjuvant therapy, some high-risk patients still face a sustained risk of recurrence for up to 20 years. Previously, available CDK4/6 inhibitor adjuvant therapies in China relied primarily on evidence from Western populations, lacking high-level evidence specific to Chinese patients.
The approval of Dalpiciclib for this early adjuvant indication is based on positive results from a large Phase III clinical study—the DAWNA-A study. This study enrolled 5,274 Chinese patients with HR+/HER2- early high-risk breast cancer, of whom approximately 60% were premenopausal or perimenopausal women, closely aligning with the characteristics of younger onset and a higher proportion of premenopausal patients in China. Data from a median follow-up of 27 months showed that Dalpiciclib combined with endocrine therapy significantly reduced the risk of disease recurrence or death by 40%, with consistent efficacy across all subgroups. Additionally, disease-free survival (DFS) and distant disease-free survival (DDFS) were also significantly improved.
Potency and Safety in Balance: Balancing Efficacy and Quality of Life
While effectively reducing the risk of recurrence, Dalpiciclib also demonstrates a favorable safety profile. The DAWNA-A study showed that in terms of liver safety, the incidence of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at all grades in the Dalpiciclib group was comparable to the placebo group, with Grade 3 or higher ALT and AST elevations occurring in less than 1% of patients. Furthermore, no common adverse events such as diarrhea, interstitial lung disease, or QT interval prolongation were reported. The discontinuation rate due to adverse events was only 3.0%, with the vast majority of patients tolerating and completing the two-year adjuvant therapy.
Given the higher prevalence of hepatitis B virus infection among Chinese breast cancer patients and the greater demand for quality of life among younger patients, Dalpiciclib’s characteristics of “potency and good compliance” are particularly valuable. Its favorable liver safety and low gastrointestinal adverse effects help patients adhere to long-term standardized medication, ensuring treatment continuity and supporting their return to normal life.
From Advanced to Early Stage: Building a Full-Course “Chinese Solution”
Previously, Dalpiciclib has demonstrated excellent efficacy in the advanced HR+/HER2- breast cancer setting: The DAWNA-1 study confirmed its ability to significantly prolong progression-free survival in previously treated advanced patients; the DAWNA-2 study showed a median progression-free survival of 33.4 months when combined with an aromatase inhibitor as first-line therapy. With solid evidence, Dalpiciclib has become an important treatment option for Chinese patients with advanced breast cancer.
Now, with the approval of the early adjuvant indication, Dalpiciclib has successfully moved the treatment frontier to early high-risk populations, forming a complete evidence chain covering the full course of HR+/HER2- breast cancer—truly achieving “full-course support” from advanced-stage rescue to early-stage cure. This regimen has been formally included in the 2026 edition of the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines and the 2026 edition of the Breast Cancer Diagnosis and Treatment Guidelines and Standards by the Chinese Anti-Cancer Association and the Oncology Society of the Chinese Medical Association, receiving dual recommendations from authoritative domestic guidelines.
As a key innovative achievement independently developed by Hengrui Medicine in the oncology field, Dalpiciclib was initiated in 2013 and, after years of research and development, was first approved for marketing in China in 2021. Now, with the new early adjuvant indication, it has achieved full-course strategic coverage from advanced-stage rescue therapy to early adjuvant treatment. This fully demonstrates the independent innovation capabilities and clinical translation abilities of Chinese pharmaceutical companies in the field of targeted drugs. With the implementation of the early indication, Dalpiciclib will benefit thousands of early breast cancer patients, helping more families embrace the hope of a cure and continuously improving the overall level of breast cancer diagnosis and treatment in China.