Zhejiang Ang Da Jiu Li Biopharmaceutical Company

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Since 2004, Angdajiuli Biopharmaceuticals Co., Ltd. has been focusing on the research and development of anti-diabetic class II biopharmaceuticals. Core productE2HSA recombinant exenatide-human serum albumin fusion protein (Zhou Kening)

Unique Advantages

E2HSA (recombinant exenatide-human serum albumin fusion protein) is an ultra-long-acting drug developed on the basis of GLP-1, which can control the blood glucose concentration in the human body.

Long-lasting medicine, once a week

Pure biological manufacturing, purity over 99%, side effects

Low production cost, high economic efficiency

Can quickly scale up production scale

Unique Advantages

E2HSA is a combination of Exendin-4 and Human serum albumin through recombination to form a new macromolecular substance, which reduces the glomerular filtration rate and prolongs the half-life of the drug. The structure where the amino acid peptide bonds are connected makes it more stable.

Core Technologies

• The Institute of Materia Medica, Chinese Academy of Medical Sciences verified that this product has a significant hypoglycemic effect and long-term effect

• The Academy of Military Medical Sciences has verified that this product has long-term effectiveness

• Beijing Zhaoyan New Drug Research Center Co., Ltd. completed, verifying the high safety of this product

• China Food and Drug Inspection and Research Institute verified that this product is highly pure and stable

  • Fermentation and Purification
    01.Fermentation and Purification
  • Yeast High Expression Platform
    02.Yeast High Expression Platform
  • Stability Control
    03.Stability Control

Production Process

  • • 10L, 100L, 200L, 500L multi-batch linear amplification, stable quality.

    • The 500L-scale fermentation tank has been scaled up in nearly 30 batches, and the product quality remains consistent.

    • Stability studies have proved that the 50 generations of bacteria are stable.

Experiment

15L

Testing

500L

Production

2000L-5000L

Finished Product Process

Finished Product Process

Phase I Clinical Effect

  • Tolerable safety

    There was no significant difference in the incidence of TEAE between the experimental group and the placebo group. The study was safe and well tolerated.

  • Pharmacokinetics

    The average half-life ranged from 129.24 h to 159.14 h, indicating that the absorption and elimination of E2HSA after subcutaneous administration is slow, and it can meet the clinical needs of once a week.

  • Pharmacodynamics

    There were no clinically significant changes in the drug efficacy indicators (fasting plasma glucose, C-peptide, insulin, proinsulin, glucagon, fasting body weight) at each time point after administration of all subjects compared with baseline. Each dose group There was no significant difference between them, and there was no significant difference between each administration group and the placebo group.

  • Immunogenicity

    After the administration of E2HSA in each dose group, only a few subjects (about 8%) developed anti-E2HSA antibodies and anti-Exenatide-4 antibodies, and most subjects did not develop anti-drug antibodies with neutralizing drug activity, suggesting E2HSA is less likely to cause anti-drug antibodies after entering the human body, and less likely to affect the efficacy of the drug.