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About Amoytop

Amoytop Biotech is an innovative biopharmaceutical company in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. It has grown into a leading enterprise in the field of pegylated protein drugs in China. Amoytop Biotech works on better solutions to major diseases including viral hepatitis and malignant tumor, and on immunotherapy as well. Possessing innovation ability from basic research, pilot-scale research, clinical study to industrialization, Amoytop Biotech has established a complete biopharmaceutical innovation system. Up till now, Amoytop has developed 5 therapeutic biotechnological products, Pegbing (Mipeginterferon alfa-2b), Pegneugen (Telpegfilgrastim), Topleucon (Molgramostim), Topneuter (Filgrastim) and Topmega (Oprelvekin).

Among them, as a first-line drug for antiviral treatment of CHB, Pegbing has been further recognized by experts and patients for improving the clinical cure rate of CHB patients and reducing the risk of liver cancer. The other four products are mainly indicated for the treatment of neutropenia, leucopenia and thrombocytopenia resulting from cancer radiotherapy or chemotherapy.

Clinical Applications - Recombinant Protein Products

Pegbing (Mipeginterferon Alfa-2b)

First-Line Drug for CHB Patients to Achieve Clinical Cure
 
 1st 40kD Y-shape branched PEG modified interferon alfa-2b injection in the world
 Exclusive international patent Y-shape PEG structure improves drug stability
 Selective pegylation at high activity site results in higher antiviral activity
 Lower incidence of neutralizing antibody brings higher possibility to achieve SVR

Pegneugen (Telpegfilgrastim Injection)

New Generation of Long-Acting Filgrastim Drug Product

 Longer half-life, reaching 56.9-90 hours (traditional PEG-huG-CSF only 40-56.8 hours)
 Equivalent efficacy, lower dosage (only 1/3 of other launched PEG-Filgrastim)
 Lower risk, higher cost-effectiveness

Biological Reagents: Recombinant Proteins (Research Use Only)

Amoytop Biotech is devoted to constant innovation in blopharmaceutical field and strive to expand product variety. Now Amoytop Biotech has independently developed and produced a series of lyophilized powder reagents for laboratory use as well as liquid reagent products (such as hirudin, Protein A, Protein G, etc.).

 Independent research            High purity, high activity
 FDA DMF filing                        CNAS
 Customization services

Innovation

R&D Center
Amoytop's R&D center (Biosteed Gene) was founded in 2002. It was established with professional and mature innovation ability to fulfill projects industrialization and for R&D of genetic engineering technology in many fields, including genetic recombination technology, cell culture, protein purification, protein structure analysis, specification setting up, formula study, stability study etc.
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Innovation Technology Platform
After over 20 years of innovation and development, Amoytop Biotech has owned core technologies in pegylated recombinant protein modification platform, protein drugs manufacturing platform, and drug screening and optimization platform, and develops innovative drugs with project management mode.
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Innovation Team In National Key Areas
Committing to research and innovation of recombinant protein medicines, especially long-acting modification, Amoytop Biotech has developed a R&D team and system with professional and experienced experts and technical persons, and awarded as "Innovation Team in Priority Fields" by the Ministry of Science and Technology in China. The R&D team has undertaken 9 Significant New Drugs Development projects and developed 5 pegylated recombinant protein drugs.
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Key R&D Projects
Currently, our R&D team is focusing on Chronic Hepatitis B clinical cure, clinical study of 3 National Class-1 new drugs, and R&D of several candidate drugs with new mechanisms or innovative structures. Other significant achievements have also been gained.
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Why Choose Amoytop Biotech

Quality Assurance
Holding to the principle of Quality by Design, Amoytop Biotech has established a strict and efficient quality  control system following the GMP guidelines of WHO, ICH, EMA, FDA, NMPA and kept updating timely.
  • Strict quality control, adopting multiple industrial standards or higher standards
     National standard
     Registration standard
     Internal standard
     International standard
     Contract standard
  • Laboratory Accredited By CNAS
     1st pharmaceutical company passed CNAS certification in Fujian province
     10 years of CNAS laboratory operation experience
     4 testing areas
     100 recognized testing items
  • Clinical Management
     A professional clinical management team
     Basing on matrix management model
    ​​​​​​​ Clinical studies strictly according to GCP (Good Clinical Practice)
  • Production With GMP
     Production base approved for GMP by several countries' health authorities
     Various kinds of therapeutic recombinant proteins production
    ​​​​​​​ Research projects on industrialized production process of new drugs
Actively promote industry standardization
 National standards supplier of multiple cytokines
 Participated in collaborative calibration of national standards of multiple cytokines
 Participated in collaborative calibration of WHO/NIBSC/USP standards
​​​​​​​ Participated in the project research and drafting of Chinese Pharmacopoeia

News And Events​​​​​​​

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New LOGO Comes on Stage: Amoytop Biotech Improves Its Brand Image.

On January 17, Tebao Biotech held a brand image upgrade launch ceremony in Xiamen. The company's brand visual image was fully refreshed and upgraded, and a new brand LOGO and brand upgrade promotional video were released, marking the official launch of Tebao Biotech's new brand development strategy.

12/2023-06
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Launch of New Product-Pegneugen (Telpegfilgrastim Injection)

Xiamen, China, July 1, 2023/--Xiamen Amoytop Biotech Co., Ltd. (referred to as Amoytop Biotech hereinafter) today announced that Pegneugen® (Telpegfilgrastim Injection) has been approved by National Medical Products Administration (NMPA) and is available for marketing.

01/2023-07
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Counselor of the State Council and former deputy director of NDRC Hu Zucai and his delegation visit Amoytop.

On October 19, Hu Zucai, counselor of the State Council and former deputy director of the National Development and Reform Commission, accompanied by leaders of the governments of Fujian Province, Xiamen City and Haicang District, visited Tebao Biotech for investigation. Sun Li, chairman and general manager of Tebao Biotech, received the visiting leaders and gave a detailed report on the company's production, operation and development plans, and focused on the role of Pegbin (long-acting interferon) in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer. research progress in this regard.

19/2023-10
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Amoytop's Quality Center awarded CNAS certificate

Recently, Amoytop's Quality Center was awarded the certificate issued by China National Accreditation Service for Conformity Assessment (CNAS) (Certificate number: CNAS L4479).

15/2023-09

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 +86-592-6889106 / +86-18060918257
 No. 330 Wengjiao Road, Haicang, Xiamen Fujian, P.R.China
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Specialized in R&D and production of recombinant protein drugs, and committed to providing better solutions for viral hepatitis, malignant tumor and immunotherapy etc..
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