Recently, CGeneTech announced that it has received the Notice of Drug Clinical Trial Approval from the State Drug Administration (NMPA) for the development of CGT-6321, a dual target inhibitor of FGFR/VEGFR, in advanced solid tumors, which is expected to be a potential first-in-class new drug in China.

　　Founded in 2010, CGeneTech is a biotechnology company dedicated to the development of small molecule drugs in the fields of hypoglycemia, antitumor and rare diseases. Since its establishment, the company has built a rich pipeline of Class 1 innovative drugs. Its self-developed Centigliptin phosphate, a novel DPP-4 inhibitor, is in Phase 3 clinical trials and all subjects are expected to complete Phase 3 clinical trials by mid-2022. Based on the results of subjects who completed the trial, Sengliptin phosphate demonstrated a favorable safety profile and glycated hemoglobin lowering effect. If the clinical efficacy endpoints are met, its approval will fill the gap in the domestic production of DPP-4 inhibitors (the approved ones are now registered as imports) and has broad market prospects.

　　The clinical approval of CGT-6321 is another heavyweight product after Cetagliptin phosphate. It is an FGFR/VEGFR inhibitor for the treatment of advanced solid tumors. According to preclinical studies, CGT-6321 showed good safety, tolerability and pharmacokinetic characteristics in animals, and demonstrated high anti-tumor activity in several tumor cell lines and animal models. Based on the new molecular structure design, CGT-6321 has shown higher selectivity and better therapeutic efficacy in preclinical studies. It is effective not only in FGFR-positive patients, but also in FGFR-negative patients, which can significantly expand the clinical application. Compared with multi-kinase inhibitors, CGT-6321 is expected to achieve better therapeutic effects and provides ample room for subsequent single-agent and combination studies.