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CGeneTech FGFR/VEGFR Dual Target Inhibitor Approved for Clinical Use in Advanced Solid Tumors

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  • Time of issue:2021-10-22
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(Summary description) 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.

CGeneTech FGFR/VEGFR Dual Target Inhibitor Approved for Clinical Use in Advanced Solid Tumors

(Summary description) 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.

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2021-10-22
  • Views:0

  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 Shengliptin 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.

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