NEWS
最新消息
Ruige Pharmaceutical's New Generation of CDK2/4/6 Small-molecule Inhibitor Receives FDA Approval for Clinical Research
发布时间：
2021-12-30 10:32
Established in 2018, Ruige Pharmaceutical is committed to the fields of tumors, autoimmunity and metabolism, and develops "first-in-class" and "best-in-class" innovative drugs with independent intellectual property rights.
Recently, Ruige Pharmaceutical announced that its new generation of CDK2/4/6 small- molecule inhibitor RGT-419B has been received FDA approval for clinical research. RGT-419B is a new-generation tumor-targeted inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors. These inhibitors are used in combination with endocrine therapy to treat patients with premenopausal/postmenopausal hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.
In cell model experiments, RGT-419B showed single-drug activity, which has a greater inhibitory effect on the growth of estrogen receptor positive (ER+) tumor cells. In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation. In these experiments, when RGT-419B is used in combination with a selective estrogen receptor degrader or PI3K signaling pathway inhibitor, its inhibitory effect on tumor cells is further enhanced.
As a single agent and used in combination with other approved therapies, RGT-419B will initially be developed for the treatment of human epidermal growth factor receptor 2 negative (HER2-), ER+ breast cancer patients who have primary or acquired resistance to CDK4/6 inhibitors. With the widespread adoption of CDK4/6 inhibitors in clinical practice, patients with refractory and relapsed patients are becoming larger and clinically significant unmet medical needs. The clinical development project of RGT-419B will solve this resistance to CDK4/6 and other hormone receptor modulating therapies, and provide new opportunities for improving the survival and quality of life of patients with advanced breast cancer.
RGT-419B is the first of many innovative oncology drugs being developed by Ruige Pharmaceutical. Founder and CEO Dr. Qiu Xiayang said: "This milestone marks the successful entry of Ruige Pharmaceutical into the field of tumor treatment. We have found the best choice for multiple CDKs through our self-developed AI-assisted new drug development CARD platform. Successfully promoted innovative drugs to enter the clinical development stage in the United States. At the same time, we are very excited that this opportunity can bring new and differentiated treatment options to many breast cancer patients around the world.
generation,the,and,of,to,with,in,rgt-419b,patients,receptor
