Hengrui：Dalpiciclib was approved
On June 15, the NMPA official website announced that Hengrui Medicine’s self-developed CDK4/6 inhibitor, Dalpiciclib Hydrochloride Tablets, has been approved for a new indication. The new indication is for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early or locally advanced breast cancer, in combination with endocrine therapy .
This approval is based on the positive results from the DAWNA-A trial, a multicenter, randomized, double-blind Phase III study evaluating Dalpiciclib plus endocrine therapy as an adjuvant treatment in HR-positive, HER2-negative breast cancer .
The DAWNA-A study enrolled over 5,000 subjects, randomized 1:1 to receive Dalpiciclib plus endocrine therapy or placebo plus endocrine therapy. The primary endpoint was Invasive Disease-Free Survival (iDFS) .
At the 2025 ASCO Annual Meeting, Hengrui presented the pre-specified first interim analysis of DAWNA-A . With a median follow-up of 20.3 months at data cutoff, results showed that Dalpiciclib plus endocrine therapy significantly prolonged iDFS compared to placebo plus endocrine therapy (HR 0.56, 95% CI 0.43–0.71; one-sided P<0.0001), with a 4.5% absolute iDFS benefit at 2 years . The iDFS benefit was generally consistent across stratification factors and baseline subgroups. Disease-Free Survival (DFS) and Distant Disease-Free Survival (DDFS) also favored the Dalpiciclib combination over placebo . The safety profile of Dalpiciclib was generally manageable .
Dalpiciclib is an oral, selective small-molecule CDK4/6 inhibitor independently developed by Hengrui Medicine, and is the first novel highly selective CDK4/6 inhibitor independently developed in China . Prior to this approval, it had received NMPA approval for two indications: (1) in combination with fulvestrant for HR-positive, HER2-negative breast cancer that has progressed after endocrine therapy; and (2) in combination with an aromatase inhibitor as initial therapy for HR-positive, HER2-negative locally advanced or metastatic breast cancer. This is the third indication approved for this drug .
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