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Today, Shengshitaike completed a key clinical study of a new class 1 hypoglycemic drug: the phase III clinical trial of the DPP-4 inhibitor Shengliptin in the treatment of type 2 diabetes, the dose of 50mg can reach the preset trial endpoint, and the therapeutic dose of "volume" half power will further improve the safety of the drug, which is expected to become the best hypoglycemic drug
in class.
DPP-4 is called dipeptidyl peptidase-4, DPP-4 inhibitors are becoming increasingly popular in China, and the market size of such drugs (all imported) will be nearly 7 billion yuan in 2021, and the future can be expected
。 Public information shows 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, while inhibiting islet α cells to secrete glucagon, increase insulin levels, lower blood sugar, and are not easy to induce hypoglycemia and weight
gain.
The mechanism of action of such drugs coincides with the mechanism of human physiological regulation of blood sugar, and is called "the smartest hypoglycemic drug"
by experts.
Shengliptin is a Class 1 innovative drug independently developed by Shengshitaike, as a new oral DPP-4 inhibitor with high selectivity and strong inhibition, it has been shortlisted for the "Major New Drug Creation" special project of the 12th and 13th Five-Year Plan of China, and is exempted from phase II clinical trials to directly enter phase III trials
。 Shengshitaike has carried out two key phase III clinical trials of "Shengliptin in the treatment of type 2 diabetes" in China, with Professor Ji Linong, director of the Department of Endocrinology, Peking University People's Hospital, director of Peking University Diabetes Center, and former chairman of the Western Pacific Region of the International Diabetes Union as the leading PI 1000 participants
with type 2 diabetes.
The unblinded results of the phase III clinical trial of selpagliptin showed that the reduction value of glycated hemoglobin (HbA1c) at the 24th weekend of the 50mg dose group (low-dose group) reached the main clinical endpoint, which was significantly better than that of the control group
.
The subsequent 28 weeks of selpagliptin 100 mg dose group (high dose group) also showed a good drug safety profile, with a similar
incidence of adverse reactions to the placebo group.
Subsequently, the company will submit the marketing application of siogliptin to the State Medical Products Administration as soon as possible in accordance with the relevant provisions of national drug registration, so as to benefit the majority of diabetic patients
in China as soon as possible.
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 research and development and industrialization
of small molecule innovative drugs for breakthrough therapies.
With an integrated drug R&D technology platform and diversified business vision, the company has built a rich pipeline of innovative drugs, covering multiple disease fields
such as hypoglycemia, anti-cancer and rare diseases.
In addition to selgliptin, three of the company's anti-cancer drugs under development have entered the clinic, two of which have obtained clinical approval from the US FDA, taking a solid step
for the company's innovative drugs to go global.
in class.
DPP-4 is called dipeptidyl peptidase-4, DPP-4 inhibitors are becoming increasingly popular in China, and the market size of such drugs (all imported) will be nearly 7 billion yuan in 2021, and the future can be expected
。 Public information shows 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, while inhibiting islet α cells to secrete glucagon, increase insulin levels, lower blood sugar, and are not easy to induce hypoglycemia and weight
gain.
The mechanism of action of such drugs coincides with the mechanism of human physiological regulation of blood sugar, and is called "the smartest hypoglycemic drug"
by experts.
Shengliptin is a Class 1 innovative drug independently developed by Shengshitaike, as a new oral DPP-4 inhibitor with high selectivity and strong inhibition, it has been shortlisted for the "Major New Drug Creation" special project of the 12th and 13th Five-Year Plan of China, and is exempted from phase II clinical trials to directly enter phase III trials
。 Shengshitaike has carried out two key phase III clinical trials of "Shengliptin in the treatment of type 2 diabetes" in China, with Professor Ji Linong, director of the Department of Endocrinology, Peking University People's Hospital, director of Peking University Diabetes Center, and former chairman of the Western Pacific Region of the International Diabetes Union as the leading PI 1000 participants
with type 2 diabetes.
The unblinded results of the phase III clinical trial of selpagliptin showed that the reduction value of glycated hemoglobin (HbA1c) at the 24th weekend of the 50mg dose group (low-dose group) reached the main clinical endpoint, which was significantly better than that of the control group
.
The subsequent 28 weeks of selpagliptin 100 mg dose group (high dose group) also showed a good drug safety profile, with a similar
incidence of adverse reactions to the placebo group.
Subsequently, the company will submit the marketing application of siogliptin to the State Medical Products Administration as soon as possible in accordance with the relevant provisions of national drug registration, so as to benefit the majority of diabetic patients
in China as soon as possible.
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 research and development and industrialization
of small molecule innovative drugs for breakthrough therapies.
With an integrated drug R&D technology platform and diversified business vision, the company has built a rich pipeline of innovative drugs, covering multiple disease fields
such as hypoglycemia, anti-cancer and rare diseases.
In addition to selgliptin, three of the company's anti-cancer drugs under development have entered the clinic, two of which have obtained clinical approval from the US FDA, taking a solid step
for the company's innovative drugs to go global.
Typesetting| Qiao Weijun
End
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