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"Quantity" Half Achieves Double Prosperity: Tyco's Class 1 New Hypoglycemic Drug Shenggliptin Uncovers Blindness Data

  • Categories:Company News
  • Author:盛世小科
  • Origin:
  • Time of issue:2022-10-17
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(Summary description)Today, Shengshi Tyco has completed a key clinical study on a class 1 new hypoglycemic drug under development: phase III clinical trial of DPP-4 inhibitor shenggliptin in the treatment of type 2 diabetes. A dose of 50mg can reach the preset end point of the trial. A therapeutic dose of "half the dose" will further improve the safety of this drug and is expected to become the best hypoglycemic drug in the same class.

"Quantity" Half Achieves Double Prosperity: Tyco's Class 1 New Hypoglycemic Drug Shenggliptin Uncovers Blindness Data

(Summary description)Today, Shengshi Tyco has completed a key clinical study on a class 1 new hypoglycemic drug under development: phase III clinical trial of DPP-4 inhibitor shenggliptin in the treatment of type 2 diabetes. A dose of 50mg can reach the preset end point of the trial. A therapeutic dose of "half the dose" will further improve the safety of this drug and is expected to become the best hypoglycemic drug in the same class.

  • Categories:Company News
  • Author:盛世小科
  • Origin:
  • Time of issue:2022-10-17
  • Views:0

"Quantity" Half Achieves Double Prosperity: Tyco's Class 1 New Hypoglycemic Drug Shenggliptin Uncovers Blindness Data

Today, Shengshi Tyco has completed a key clinical study on a class 1 new hypoglycemic drug under development: phase III clinical trial of DPP-4 inhibitor shenggliptin in the treatment of type 2 diabetes. A dose of 50mg can reach the preset end point of the trial. A therapeutic dose of "half the dose" will further improve the safety of this drug and is expected to become the best hypoglycemic drug in the same class.

The full name of DPP-4 is dipeptidyl peptidase-4. DPP-4 inhibitors are becoming increasingly popular in China. In 2021, the market size of such drugs (all imported) will be nearly 7 billion yuan, and the future is promising. Public data show that such drugs can not only inhibit DPP-4, prevent it from inactivating glucagon like peptide-1 (GLP-1) and glucose dependent insulin secreting polypeptide (GIP), but also promote insulin release and inhibit islets α The cells secrete glucagon, increase insulin level, reduce blood sugar, and are not easy to induce hypoglycemia and weight gain. The mechanism of action of such drugs is consistent with the mechanism of human physiological regulation of blood sugar, which is called "the most intelligent hypoglycemic drug" by experts.

Shenggliptin is a Class 1 innovative drug independently developed by Shengshi Tyco. As a new type of oral DPP-4 inhibitor, it has the advantages of high selectivity and strong inhibition. It has been selected for the National Twelfth Five Year Plan and the 13th Five Year Plan "Major New Drug Creation" project, and exempted from Phase II clinical trials and directly entered Phase III trials. Shengshi Tyco has carried out two key phase III clinical trials of "shenggliptin in the treatment of type 2 diabetes" in China. Professor Ji Linong, director of Endocrinology Department of Peking University People's Hospital, director of diabetes center of Peking University, and former president of Western Pacific region of International Diabetes alliance, is the leading pi. The research contents are the phase III trial of shenggliptin tablets alone and the phase III trial of shenggliptin tablets combined with metformin, About 1000 subjects with type 2 diabetes were enrolled.

The unblinding results of the phase III clinical trial of Shenggliptin showed that the decrease of HbA1c in the 50mg dose group (low-dose group) of Shenggliptin tablets reached the main clinical end point at the end of the 24th week, which was significantly better than that in the control group. After 28 weeks, the 100mg dose group (high-dose group) of Shenggliptin also showed good drug safety, and the incidence of adverse reactions was similar to that of the placebo group. Subsequently, the company will submit the listing application of shenggliptin to the State Drug Administration as soon as possible in accordance with the relevant provisions of the national drug registration, so as to benefit the majority of diabetes patients in China as soon as possible.

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 research, development 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 hypoglycemic, anti-cancer and rare diseases. In addition to Shenggliptin, three anti-cancer drugs developed by the company have entered the clinic, two of which have been approved by the FDA of the United States, making a solid step forward for the company's innovative drugs to go abroad.

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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