Hengrui Medicine's application for the listing of CDK 4/6 inhibitors has been accepted and R&D investment nearly 2...

Source: Guanlan Pharmaceutical

On April 27, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that Hengrui Medicine's Class 1 new drug CDK 4/6 inhibitor SHR6390 tablets had submitted a new drug marketing application and was accepted.

Screenshot source: CDE official website

CDK 4/6 (cyclin-dependent kinase 4 and 6) is a key regulator that drives cell division.

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.

On March 17, SHR6390 tablets were included in the CDE breakthrough treatment category announcement.

Screenshot source: CDE official website

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.

It is reported that in addition to the second-line treatment of hormone receptor-positive breast cancer, SHR6390 is also undergoing key research on its application in advanced first-line related treatments.

Breast cancer is the most common cancer among women worldwide.

According to the announcement issued by Hengrui Medicine on April 26, the world’s approved CDK 4/6 inhibitors include palbociclib (trade name: Ibrance) developed by Pfizer and ribociclib (trade name: Novartis) developed by Novartis.

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