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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 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.

Shengshi

Shengshi Taike has been awarded the "Double Yellow Egg" of Jiangsu Province's innovation and entrepreneurship talents

Jiangxiang is near Xiaoman, with warm air and moving grasshoppers. Recently, the selection results of Jiangsu Province's "Double Innovation Plan" for 2024 have been officially announced. Shengshi Taike's talent team has won the "Double Yellow Egg" award: the core team led by Dr. Wang Tong, Chief Scientific Officer, has been successfully selected as the "Double Innovation Team" in Jiangsu Province in 2024, and is the only "Innovation Team" in the field of biomedicine in Suzhou; Dr. Zhao Jiahong, Chief Medical Officer, has been successfully selected as a "Double Innovation Talent" in Jiangsu Province in 2024. The "Double Innovation Plan" in Jiangsu Province mainly focuses on introducing and funding scarce talents in the "high-precision and cutting-edge" and "bottleneck" fields, supporting the development of new technologies in key areas, and is an important brand project for talent work in Jiangsu Province. This plan focuses on the key industries prioritized for development in Jiangsu Province, playing an important role in enhancing independent innovation capabilities, promoting industrial structure optimization and upgrading, and driving rapid economic development. Dr. Wang Tong was just awarded the title of "Double Innovation Talent" in Jiangsu Province last year, and this time he led the company's core team to win the honor of "Double Innovation Team" in Jiangsu Province, fully reflecting the continuous innovation ability of the company's talent team. Dr. Wang Tong, as the Chief Scientific Officer of Shengshi Taike, has over 20 years of experience in the full chain drug research and management of top pharmaceutical companies and research institutes in the United States. He is a strategic scientist who can break through key technologies, drive emerging disciplines, and promote the new drug industry. Since joining Shengshi Taike, I have been awarded the title of leading technology talent at all levels, bringing innovative thinking and advanced technological means to the company. I have integrated and formed a complete new drug development and industrialization platform, leading the company's R&D team to accelerate the development of the new drug product pipeline. One of the core product pipelines, the hypoglycemic drug sengliptin, has been launched for sale. Dr. Zhao Jiahong, a core member of the "Double Creation Team", was also awarded the honor of "Double Creation Talent" in Jiangsu Province this time. Dr. Zhao Jiahong, as the Chief Medical Officer of Shengshi Taike, has over 20 years of experience in drug clinical trials and team management, and is an external expert of CDE; Has rich practical experience in medical affairs and early drug development, clinical development strategies, and international multicenter clinical trials, and has led and participated in over 600 clinical projects; I also have some experience in post market re evaluation of drugs. Since joining Shengshi Taike, I have been fully responsible for the company's new drug clinical development strategy and pathway, as well as post market expansion research and other important tasks. Among the core members of the "Double Creation Team", Dr. Lu Qin graduated from Fudan University with a major in Medical Systems Biology and holds the associate senior professional title. She has achieved fruitful research results in the field of biology, published multiple high-quality papers, obtained nearly 10 authorized invention patents, led the company's biology team to complete multiple project research tasks, and won multiple honors such as leading the park. Dr. Ouyang Zhenwu graduated from the Organic Chemistry Department of the Chinese Academy of Sciences. He has demonstrated outstanding academic and professional achievements in the field of pharmaceutical chemistry. He has published six high-quality papers in internationally renowned chemical journals, demonstrating his profound skills in chemical synthesis and drug design. Since joining the company, Dr. Ouyang has repeatedly used "innovative synthesis methods" to simplify the synthesis route, which not only significantly improves the efficiency of new drug screening, but also saves costs for the company in new drug development. Shengshi Taike, composed of these innovative talent teams, is a biotechnology company in the commercial stage. The core team has decades of experience in the entire lifecycle of international drugs and is committed to the research and industrialization of high-quality and differentiated small molecule innovative drugs. The company has built a rich pipeline of innovative drugs covering hypoglycemic, anticancer, and autoimmune diseases through an integrated drug research and development technology platform and diversified business perspectives.
2025-05-22
Media

Media Attention | Yu Qiang, an "unsmart" entrepreneur, and his new diabetes drug Sengliptin

Qiang Yu, the founder and CEO of CGeneTech, a doctor of chemistry from Peking University, founded a biotechnology company in the United States at the beginning of this century, and later returned to China to found CGeneTech and developed a new type 2 diabetes drug, a new generation of DPP-4 inhibitor senpaglitin, which has now been approved for marketing.
2025-04-16

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