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Hengrui Medicine's application for the listing of CDK4/6 inhibitors has been accepted
发布时间：
2021-04-29 16:45
Hengrui Medicine's application for the listing of CDK4/6 inhibitors has been accepted
On April 27, the Center for Drug Evaluation (CDE) announced that the new drug listing application submitted by Hengrui Medicine's Class 1 new drug CDK 4/6 (cyclin-dependent kinase 4 and 6)inhibitor SHR6390 tablets has been accepted, and the indication is: combined with Fulvestrant for hormone receptor (HR) positive and treatment of recurrent or metastatic breast cancer that is negative for human epidermal growth factor receptor 2 (HER2) after endocrine therapy.
Breast cancer is the most common cancer among women worldwide. The most common subtype is the HR positive/HER2 negative subtype, which accounts for 70% of the total number of Breast cancer patients. Approximately 30% of patients diagnosed with HR-positive and HER2-negative early breast cancer are still at risk of cancer recurrence. At present, the combination therapy of CDK 4/6 inhibitors and endocrine drugs has become a new model for reversing the resistance of endocrine therapy, significantly improving the prognosis of patients with HR-positive advanced Breast cancer.
CDK 4/6 is a key regulator that drives cell division. Studies have found that CDK 4/6 is overexpressed in many cancer cells, leading to uncontrolled cell division cycles and unlimited proliferation. Clinical studies have confirmed that more than half of breast cancer patients overexpress cyclin D (cyclin D), and most of them are HR-positive breast cancer patients. Because cyclin D directly acts on CDK 4/6, CDK 4/6 has become an important molecular target for patients with HR-positive metastatic breast cancer.
SHR6390 is an oral, high-efficiency and selective small molecule CDK 4/6 inhibitor developed by Hengrui Medicine, which is a Class 1 new drug. It can selectively inhibit CDK 4/6 kinase activity, thereby blocking the CDK 4/6-retinoblastoma protein (Rb) signaling pathway, thereby inducing tumor cell G1 blockade, and selectively inhibiting the high expression of Rb Of tumor cells proliferate. Therefore, SHR6390 plays a decisive role in blocking the process of cells from G1 phase to S phase, thereby effectively inhibiting tumor cell proliferation, achieving the effect of anti-tumor and prolonging the survival of patients.
Public information shows that SHR6390 has reached the pre-designated superiority standard in a multi-center, randomized, controlled, double-blind phase 3 clinical study named SHR6390-III-301. Compared with placebo and fulvestrant, it accepts SHR6390 combined with Fulvestrant can significantly prolong the progression-free survival of patients.
The arrival of Hengrui Medicine SHR6390 is expected to bring new treatment options for breast cancer patients.
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