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DESCRIPTION
SEMAGLUTIDE injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one
fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol.
Structural formula:
SEMAGLUTIDE is a sterile, aqueous, clear, colorless solution. Each pre-filled pen contains a 1.5 mL or a 3 mL solution of SEMAGLUTIDE equivalent to 2 mg semaglutide, a 3 mL solution of OZEMPIC® equivalent to 4 mg of semaglutide, or a 3 mL solution of OZEMPIC® equivalent to 8 mg of semaglutide. Each 1 mL of SEMAGLUTIDE solution contains 0.68 mg, 1.34 mg or 2.68 mg of semaglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14.0 mg; phenol, 5.50 mg; and water for injections. SEMAGLUTIDE has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
Mechanism of Action
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is
high, insulin secretion is stimulated, and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.
Pharmacodynamics
Semaglutide lowers fasting and postprandial blood glucose and reduces body weight. All pharmacodynamic evaluations were performed after 12 weeks of treatment (including dose escalation) at steady state with semaglutide 1 mg. Fasting and Postprandial Glucose Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes, treatment with semaglutide 1 mg resulted in reductions in glucose in terms of absolute
change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose, and 30 mg/dL (22%) for mean 24-hour glucose concentration. (see Figure 1).
Insulin Secretion
Both first-and second-phase insulin secretion are increased in patients with type 2 diabetes treated with OZEMPIC® compared with placebo. Glucagon Secretion Semaglutide lowers the fasting and postprandial glucagon concentrations. In patients with type 2 diabetes, treatment with semaglutide resulted in the following relative reductions in glucagon compared to placebo, fasting glucagon (8%), postprandial glucagon response (14-15%), and mean 24 hour glucagon concentration (12%). Glucose dependent insulin and glucagon secretion Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner. With semaglutide, the insulin secretion rate in patients with type 2 diabetes was similar to that of healthy subjects (see Figure 2).
During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes. Gastric emptying
Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially. Cardiac electrophysiology (QTc) The effect of semaglutide on cardiac repolarization was tested in a thorough QTc trial. Semaglutide does not prolong QTc intervals at doses up to 1.5 mg at steady-state.
Name: Semaglutide
Semaglutide is a prescription medicine used to treat the symptoms of Type 2 Diabetes Mellitus. Semaglutide may be used alone or with other medications.
Dosage: Injection
Specification
5ml: 0.25mg
Indications
SEMAGLUTIDE is indicated:
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Semaglutide to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
Jiuyuan Gene adheres to the concept of "guided by genetic engineering and contributes to human health", bravely innovating and pursuing excellence.
In October 1996, the company took the lead in the domestic development of the white blood cell-boosting special drug-Jilifen (rhG-CSF) and realized its industrialization, breaking the monopoly of the US and Japanese manufacturers and winning the reputation of "China's first injection".
For more than 20 years, Jiuyuan Gene has successively launched Ji Lifen, Ji Pai Lin, Ji Jufen, Yi Zhe Jia, Ji Ou Ting and Bone Youdao series products.
Honor
Leading Enterprise in Zhejiang Province
Genetic engineering new drug research and development technology service sub-platform
The first batch of post-doctoral research workstations in the province
Excellent Industrial Products of Zhejiang Province
Hangzhou Academician Expert Workstation
Top ten high-tech enterprises in Hangzhou
Zhejiang Green Enterprise
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