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The CDK 4 / 6 inhibitor Birociclib, a innovative drug of XZenith, was approved for phase III clinical trial

Recently, XZenith received the notice that CDE has approved the phase III clinical trial of class 1 innovative drug Birociclib (XZP-3287). XZenith has held a phase III clinical launch meeting of Birociclib and will start the clinical trial in the near future.


The results of clinical phase I studies show that as a newly structured CDK 4 / 6 inhibitor, Birociclib is expected to overcome the resistance of endocrine therapy in HR + breast cancer patients, and the obvious efficacy of Birociclib monotherapy in advanced breast cancer patients with multiline therapy failure. The results of preclinical studies indicate that Birociclib has unique pharmacokinetic characteristics and can effectively cross the blood-brain barrier, and is expected to produce good efficacy in patients with breast cancer brain metastasis and patients with brain cancer. Moreover, due to the novel target mechanism of action of CDK 4 / 6, Birociclib can be used in combination with a variety of target drugs, which has important clinical significance and broad market prospects.


Breast cancer is one of the malignant tumors with high incidence in the world. According to the data released by IARC, the new incidence of breast cancer patients reached 2.26 million in 2020, surpassing lung cancer to become a malignant tumor with high incidence in the world. It is also a malignant tumor with high incidence in women worldwide, and about 680,000 patients die from breast cancer. In 2020, there were about 420,000 new breast cancer patients and about 120,000 deaths in China, which is one of the common causes of death from malignant tumors in women. HR + breast cancer accounts for about 70% of all breast cancers, and is the population with a high proportion of breast cancer. Currently, the drugs of concern in this field are CDK 4 / 6 inhibitors, which restore cell cycle control by selectively inhibiting CDK 4 / 6, restore cell cycle control and block tumor cell proliferation. In 2020, the annual sales of CDK 4 / 6 listed products exceeded US $7 billion, and the global market size is expected to exceed US $15 billion in 2025.