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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.

The

The world's first SGLT-2/DPP-4 dual target inhibitor with complementary advantages has been approved for clinical use

Recently, Shengshi Taike's Class 1 innovative drug SGLT-2/DPP-4 dual target inhibitor CGT-2201 has been granted implicit permission for clinical trials by the National Drug Administration. CGT-2201, which targets SGLT-2 and DPP-4, two important targets related to glucose metabolism, can be better used for the treatment of diabetes and its derivatives, including diabetes nephropathy and non-alcoholic fatty liver disease. In 2021, the number of diabetes patients in China will reach 141 million, ranking first in the world. Among the numerous patients with diabetes in China, 20-40% may suffer from complications of diabetes nephropathy. Among the existing hypoglycemic drugs, only sodium glucose cotransporter 2 (SGLT-2) inhibitor has significant renal protection effect in clinical verification, but its inherent reproductive and urinary system infection risks limit its use. Based on SGLT-2 inhibitors and combined with the characteristics of dipeptidyl peptidase 4 (DPP-4) inhibitors, we design and develop a drug that can improve blood sugar, reduce side effects of urinary and reproductive system infections, is not limited by renal function, and has kidney benefits. It is expected to fill the market gap and meet the needs of patients. Based on this market background and target characteristics, Shengshi Taike utilizes its own small molecule chimera drug technology platform to develop multi head multifunctional new drug products with synergistic mechanisms, with CGT-2201 being one of its representative works. It fuses the respective mechanism characteristics of SGLT-2 and DPP-4. On the basis of inhibiting the activity of SGLT-2 to reduce the reabsorption of glucose in the kidney, it also slows down the inactivation of DPP-4 on GLP-1, playing a dual role mechanism to play a superposition effect; While achieving considerable hypoglycemic effect, it can reduce the side effects of existing SGLT-2 drug urinary system infection; At the same time, without kidney excretion, it can reduce the burden of the kidney and reduce the contraindication of diabetes patients with renal insufficiency. Therefore, this drug will have the advantage of better controlling blood sugar and protecting patient kidney function. Shengshi Tyco was founded in Suzhou Industrial Park in 2010. Its core team has decades of experience in the whole life cycle of international drugs, and is committed to the R&D and industrialization of high-quality and differentiated small molecule innovative drugs. The company has built a product pipeline covering multiple disease fields such as hypoglycemic, anticancer, and autoimmune diseases with an integrated drug research and development technology platform and a diversified business perspective. In the field of hypoglycemic drugs, Shenggliptin, the core product independently developed by the company, has submitted an NDA (product launch application) to the National Drug Administration and has been accepted. The results of the Phase 3 clinical trial showed that low doses can reach the predetermined trial endpoint, while the high-dose group can also demonstrate the safety of the drug well. The therapeutic effect of "half the dose" is twice as effective, making it expected to become the best hypoglycemic drug in the class. At the same time, the company has also carried out a comprehensive layout around oral drugs and derivative diseases of various targets related to diabetes. CGT-2201, which was approved for clinical use this time, is one of its pipeline matrix members.
2023-04-20

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