According to company's development strategy, basing on the characteristics, life cycle management and trends in regulatory requirements of recombinant protein drugs, Amoytop Biotech has built a complete research and development system of innovative drug, covering drug upstream & downstream technology development, quality and druggability research, preclinical and clinical research, and industrialization research.
Insisting on constant innovation and development, Amoytop Biotech has created research and development team for therapeutic recombinant proteins and relevant long-acting modified innovative drugs, which was selected as the "Innovation Team in Priority Fields" of the Ministry of Science and Technology (No. 2013RA4020). Since the“11 five-year plan”, this team has undertook nine Significant New Drugs Development projects of National Major Scientific and Technological Special Project, and developed 5 pegylated recombinant protein drugs (4 in clinical trial stage and 1 already in the market). Amoytop Biotech has become a leading biopharmaceutical company in the field of pegylated protein drugs in China.
Amoytop Biotech owns professional research and development center “Xiamen Biosteed Gene Transformation Co., Ltd”, meanwhile has created postdoctoral research station and national-local joint research center, and has sufficient talent reserves to break through key core technologies.
| Number | Project Name/Code | Application Prospect |
|---|---|---|
| 1 | Clinical study of CHB clinical cure |
In the future , pegylated interferon will have a considerable potential market, if more clinical evidence show that sequential/combination treatment with Pegylated interferon alfa and nucleoside (acid) drugs can improve the clinical cure rate of chronic hepatitis B, and relevant treatment regimen and concepts can be recognized by more clinicians and patients. |
| 2 | Pegfigrastim (Y-shape) |
Long-acting recombinant human granulocyte colony-stimulating factor, mainly used for neutropenia induced by cancer chemotherapy |
| 3 | PEG-EPO (Y-shape) |
Long-acting recombinant human erythropoietin, mainly used for anemia caused by chronic kidney disease. |
| 4 | PEG-Somatropin (Y-shape) |
Long-acting recombinant human growth hormone, mainly used for growth hormone deficiency in pediatric patients. |
| 5 | ACT50 |
A new pegylated protein drug targeting αvβ3, mainly used for tumors and neo-angiogenesis related diseases. |
| 6 | ACT60 |
A drug combination of glucocorticoids and IL-2 stimulants, mainly used for immune diseases, e.g. allergic respiratory tract. |
After over 20 years of innovation and development, Amoytop Biotech has owned many core technology platforms, including pegylated recombinant protein modification platform, protein drugs manufacturing platform and drug screening and optimization platform, as well as many protein expression platforms and cloning platform. Continuous investment in high level research and development brings Amoytop Biotech not only the sustainable development in the field of new drug research and development, but also the foundation and potential to break through key core technologies.
Up to now, Amoytop Biotech and its subsidiaries have a total of 12 invention patents, including multiple PCT patents, covering China, Europe, the United States, Canada, Japan, South Korea and some other countries and regions, undertook and successfully completed 18 national key projects, including“National High Technology Research and Development Program” and “National Major Scientific and Technological Special Project for Significant New Drugs Development”.
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