This is the company's third Class 1 new drug approved for clinical trials in China this year.
In recent years, CDK4/6 inhibitors are becoming a rising "new star" in cancer treatment. CDK4/6, or cyclin-dependent kinases 4 and 6, are key regulatory proteins in the human cell division and proliferation cycle, triggering the transition from the growth phase to the DNA replication phase. CDK4/6 is overly active in many malignant tumors, promoting the proliferation and spread of cancer cells, while CDK4/6 inhibitors can arrest the cell cycle in the growth phase, thereby exerting an inhibitory effect on tumor cell proliferation.
Currently, the global CDK inhibitor market size continues to expand, growing from US$723 million in 2015 to US$7.7 billion in 2021. At present, five CDK4/6 inhibitors have been approved for marketing worldwide, with their main therapeutic areas focused on solid tumors such as breast cancer.
Dr. Tong Wang, Chief Scientific Officer of CGeneTech, stated: "CGT-1967, developed by CGeneTech, utilized the company's PD2 (Precision Oncology Drug Development) platform during the preclinical development process. In mouse model studies, it significantly inhibited tumor cell occupancy in the blood, spleen, and bone marrow, extending animal survival. Therefore, under the philosophy of 'beginning with the end in mind,' we have made a differentiated choice to explore its use in treating Acute Myeloid Leukemia (AML) patients, addressing unmet clinical needs in this field."
CGeneTech was founded in 2010 in Suzhou Industrial Park. The core team has decades of international experience in the entire lifecycle of pharmaceuticals and is committed to the research and industrialization of small molecule innovative drugs for breakthrough therapies. With an integrated drug discovery technology platform and diverse commercial perspectives, the company has built a rich pipeline of innovative drugs, covering multiple disease areas such as blood sugar reduction, cancer treatment, and autoimmune disorders.
Among the anticancer drugs under research, except for CGT-1967, three have entered clinical trials: CGT-6321, a dual-target inhibitor of FGFR/VEGFR, has entered Phase I clinical trials for advanced solid tumors and is expected to become a potential first-in-class drug; CGT-1881, used in treatment areas such as hematopoietic stem cell mobilization, is the only original small-molecule oral CXCR4 antagonist produced in China, offering more convenient administration; and the new-generation ALK inhibitor CGT-9475, which is expected to address major clinical challenges such as drug resistance and brain metastasis in lung cancer treatment. The latter two projects have received clinical approval from the U.S. FDA, marking a solid step forward in the company's innovative drug internationalization. Additionally, the company's core product, Steglitinib, has completed its pivotal Phase III clinical trial, and a New Drug Application (NDA) will soon be submitted. Its "half-dose for full efficacy" treatment effect is expected to make it the best-in-class hypoglycemic drug.
