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    About Amoytop Biotech

    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 6 therapeutic biotechnological products, Pegbing (Mipeginterferon alfa-2b), Pegpesen (Inpegsomatropin), 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 5 products are mainly indicated for the treatment of neutropenia, leucopenia and thrombocytopenia resulting from cancer radiotherapy or chemotherapy, or for growth retardation caused by growth hormone deficiency in children.

    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

    Pegpesen (Inpegsomatropin Injection)

    1st Y-shape PEG Modified Growth Hormone

     The first 40kD Y-shape branched PEG modified long-acting growth hormone             injection in the World.
     Brand new International Nonproprietary Name approved by WHO.
     Lower risk, higher cost-effectiveness

    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 has multiple expression platforms, including Escherichia coli (E.coli), Pichia Pastoris, mammalian cell (CHO), etc. Basing on the above platforms, a series of recombinant proteins have been developed, to meet the needs of scientific research institutes and laboratories.
     
     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.

    News And Events​​​​​​​

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    Approval Granted for Amoytop Biotech's Pegpesen®, a Next-Gen Long-Acting Growth Hormone

    On May 29, Amoytop Biotech's independently developed Class 1 new drug, Inpegsomatropin Injection(trade name: Pegpesen®), the world's first Y-shaped 40-kDa PEGylated long-acting growth hormone, officially received market approval from the National Medical Products Administration (NMPA). This drug is

    2025-06-23
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    AMOYTOP BIOTECH ANNOUNCES CLINICAL COLLABORATION WITH ALIGOS THERAPEUTICS INC

    Jul 22, 2024Xiamen, China, July 22, 2024/--Xiamen Amoytop Biotech Co., Ltd. (referred to as Amoytop hereinafter) today announced that it has entered into a clinical trial collaboration agreement with Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”).

    2024-07-22
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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.

    2023-10-19
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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.

    2023-07-01

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    Active Pharmaceutical Ingredients (APIs) are the core components of any therapeutic product, determining its effectiveness and quality. Amoytop Biotech specializes in the development and production of high-quality APIs for a wide range of pharmaceutical applications.

    The cytokine products for research are supplied in Lyophilized form. We can also provide liquid reagent products, such as Hirudin, Protein A, Protein G, etc. To offer maximum flexibility for researchers, custom-manufacturing is also available, from microgram to milligram.
    Amoytop Biotech offers a comprehensive range of drug products designed to address critical medical needs in the fields of hepatitis treatment and cytokine therapy. Our innovative solutions enhance patient outcomes through advanced biotechnology.

    Contact Us

     +86-592-6889106 / +86-18060918257
     international@goodwjj.com /reagent@goodwjj.com
     No. 330 Wengjiao Road, Haicang, Xiamen, Fujian, 
        P.R.China
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    WELCOME

    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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