Amoytop Biotech: Pioneering Hepatitis Treatment Manufacturer

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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 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.

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 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

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.

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.

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.

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.

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, Multiple Industrial Standards & Higher Standards
Actively Promote Industry Standardization
Laboratory Accredited By CNAS
Clinical Management
Production With GMP

Strict Quality Control, Multiple Industrial Standards & Higher Standards

● National standard
● Registration standard
● Internal standard
● International standard
● Contract standard
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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

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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
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Clinical Management

● A professional clinical management team
● Basing on matrix management model
● Clinical studies strictly according to GCP (Good Clinical Practice)
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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
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News And Events

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

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

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).

2023-09-15

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

Contact Us

+86-592-6889106 / +86-18060918257

international@amoytop.com /reagent@amoytop.com

No. 330 Wengjiao Road, Haicang, Xiamen, Fujian,

P.R.China

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..

Fax: +86-592-6889110
international@amoytop.com
Tel: +86-592-6889106

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