Sihuan Pharmaceutical's Class 1 new drug CDK4/6 inhibitor approved for Phase III clinical treatment of breast cancer

Article source: Medical Rubik's Cube Info

On August 12, Sihuan Biological issued an announcement stating that its subsidiary Xuanzhu Biological's application for a phase III clinical trial of Pirosinil (Birociclib, XZP-3287), a class 1 innovative drug under development, was approved by the China Food and Drug Administration

Breast cancer is one of the highest incidence of malignant tumors in the world.

The results of the clinical phase I study showed that as a new structure of CDK4/6 inhibitor, Pirosinib is expected to overcome the resistance problem of endocrine therapy in HR+ breast cancer patients; at the same time, Pirosinib is a single agent for advanced breasts that have failed multi-line therapy.

At present, there are 3 domestic companies that have approved the listing of CDK4/6 inhibitor drugs, namely Eli Lilly, Pfizer and Qilu Pharmaceuticals

Source: PharmaGo

In 2020, the annual sales of CDK4/6 products on the market will exceed 7 billion U.