By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that a new indication approval filing for its CDK4/6 inhibitor dalpiciclib (SHR6390) has been accepted for review by the National Medical Products Administration (NMPA). The filing seeks approval for dalpiciclib in combination with endocrine therapy as adjuvant treatment for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative early or locally advanced breast cancer.
Dalpiciclib Background
Dalpiciclib is China’s first domestically developed CDK4/6 inhibitor. It received initial market approval in December 2021 for the treatment of HR-positive and HER2-negative recurrent or metastatic breast cancer that has progressed after endocrine therapy, in combination with fulvestrant. In June 2023, the drug was further approved as a first-line therapy in combination with an aromatase inhibitor for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.
Clinical Trial Results
The filing is supported by positive results from the SHR6390-Ⅲ-303 study, which enrolled over 5,000 subjects. The study demonstrated that dalpiciclib combined with endocrine therapy significantly reduced the risk of recurrence and improved non-invasive disease survival compared to placebo combined with endocrine therapy.-Fineline Info & Tech