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China and the United States reported that the new generation of ALK inhibitor of Shengshi Tyco was approved for clinical use in the United States

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  • Time of issue:2022-08-10
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(Summary description)Today, the new generation ALK inhibitor cgt-9475 independently developed by Shengshi Tyco has been approved by the US Food and Drug Administration (FDA) for clinical trials. This drug is expected to solve several major clinical pain points such as drug resistance and brain metastasis in the treatment of lung cancer. This is another new drug project approved by Shengshi Tyco after the CXCR4 antagonist cgt-1881 was approved in China and the United States.

China and the United States reported that the new generation of ALK inhibitor of Shengshi Tyco was approved for clinical use in the United States

(Summary description)Today, the new generation ALK inhibitor cgt-9475 independently developed by Shengshi Tyco has been approved by the US Food and Drug Administration (FDA) for clinical trials. This drug is expected to solve several major clinical pain points such as drug resistance and brain metastasis in the treatment of lung cancer. This is another new drug project approved by Shengshi Tyco after the CXCR4 antagonist cgt-1881 was approved in China and the United States.

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2022-08-10
  • Views:0

Today, the new generation ALK inhibitor cgt-9475 independently developed by Shengshi Tyco has been approved by the US Food and Drug Administration (FDA) for clinical trials. This drug is expected to solve several major clinical pain points such as drug resistance and brain metastasis in the treatment of lung cancer. This is another new drug project approved by Shengshi Tyco after the CXCR4 antagonist cgt-1881 was approved in China and the United States.

Lung cancer is the leading cause of cancer death in the world and the leading cause of cancer death in China. Lung cancer is generally divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Among them, NSCLC accounts for 80% - 85%, and about 3% - 7% of NSCLC patients have ALK gene mutations. Some patients with ALK positive advanced NSCLC had brain metastases at the initial diagnosis, and the incidence increased with time, which posed a severe challenge to the survival of patients.

The new generation ALK inhibitor cgt-9475 under research by the company aims to overcome drug resistance and solve the problem of central nervous system metastasis through high-quality and differential development. In preclinical studies, the drug can simultaneously inhibit ALK and RET in non-small cell lung cancer cell lines. At the same time, the drug showed good blood-brain barrier penetration effect in preclinical studies, which will bring new hope to NSCLC patients with brain metastasis. Therefore, cgt-9475 is expected to be used in the follow-up treatment after the resistance of existing ALK inhibitors.

Dr. Wang Tong, chief scientific officer of Shengshi Tyco, said: "I am very glad that cgt-1881 and cgt-9475 have been approved to enter the clinical stage by both China and the United States. Through high-quality and differentiated development, cgt-9475 can inhibit ALK and RET at the same time, and is expected to solve several major clinical pain points such as drug resistance and brain metastasis in the treatment of NSCLC. It has a broader market. I hope that cgt-9475 can be promoted in clinical trials in China and the United States as soon as possible, and benefit patients worldwide as soon as possible."

Shengshi Tyco was founded in Suzhou Industrial Park in 2010. The core team has decades of experience in the whole life cycle of international drugs, and is committed to the R & D and industrialization of small molecule innovative drugs for breakthrough therapies. Relying on the integrated drug R & D technology platform and diversified business vision, the company has built a rich pipeline of innovative drugs, covering many disease fields such as glucose lowering, anticancer and rare diseases.

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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