Company Name
XIAMEN AMOYTOP BIOTECH CO., LTD.
Year of Establishment
1996
Enterprise Size
more than 1000
Annual Turnover(USD)
Other
Company Introduction
Xiamen Amoytop Biotech Co., Ltd., established in 1996, is a leading biopharmaceutical company in China, specializing in the research, development, manufacture and marketing of recombinant protein products. Amoytop provides not only drug product, drug substance and reagent, but also the services of contract manufacturing and contract research.
Taking quality as the most important objective, Amoytop carries out the state-of-the-art manufacturing processes under cGMP in its 36,000m2-covered plant, which is highly equipped and composed of professional staff.
As a R&D oriented company, Amoytop has already launched a series of recombinant protein products including Molgramostim, Filgrastim and Oprelvekin, and developed Interferon alfa-2a, Interferon alfa-2b, Interferon gamma, Interleukin 2 and Somatropin. Furthermore, basing on its own technical platform, Amoytop has completed the development of patented pegylated products, including Peginterferon alfa-2b (Y-shape), Pegfilgrastim (Y-shape), Peginterferon alfa-2a (Y-shape), , PEG-Somatropin (Y-shape) and PEG-EPO (Y-shape), among which Peginterferon alfa-2b (Y-shape) has been approved for marketing in China while others are in different stages of clinical trials in China now.
Aiming to improve the life quality of people, Amoytop is actively developing the international market to supply therapeutic biological products with all the endeavors.
Main Competitive Advantages
Brand Name,Experienced R&D Staff,Production Capacity,Large Product Line,Buyers' Specifications Accepted,Small Orders Accepted,Reputation,Quality Service,
Website
http://www.amoytop.com
Other Competitive Advantages
Amoytop Biotech, as a leading enterprise on exporting recombinant protein drugs in China, has passed GMP inspections from several countries' health authorities, including Pakistan, Brazil, and Russia, etc.
Patents and Copyright
Two patents for the structure of Pegberon®
- Patent of Y-shape branched PEG structure (Y-shape):
International Application No.: PCT / CN/03/ 00179, International Publication Number: WO 03/076490;
- Patent of structural site and preparation process:
International Application No.: PCT / CN2007 / 002644, International Publication Number: WO 2009/030066;
Covers 30 regions and countries, including China, America, Europe, Japan, Korea, Canada, Australia, Russia, S . Africa, etc.
Expiry date of patent: 2027
Milestone
Soon in 2025, Launched Pegpesen (Inpegsomatropin), the long acting grwoth hormone
2023 Lauched Pegneugen (Telpegfilgrastim), National Class I New Drug
2016 Launched Pegbing (Mipeginterferon alfa 2b), National Class I New Drug
2013 Awarded as National Innovation Team in Priority Areas by MOST
2012 Awarded as the Major High-Tech Enterprise in National Torch Plan
2012 Approved as National-local Joint Research Center for Recombinant Protein Drugs
2011 Awarded as National Innovation-oriented Enterprise
2010 Undertook demonstration project for national high-tech industrialization
2009 Undertook several major national projects for research and development of new biological drugs.
2009 Took part in establishment of its first oversea plant for biological drugs.
2008 Established a post-doctoral workstation in Amoytop Biotech.
2006 Established Xiamen Biomedical Incubator, the major scientific and technical platform of Xiamen.
2005 Commercialized TOPMEGATM (rHuIL-11) in China.
2005 Entrusted by NICPBP to carry out the research and development work on national reference standards of seven recombinant protein products.
2004 Undertook the Pilot Project of Industrialization and Internationalization of Genetically Engineered Protein Drugs for National Development and Reform Committee, China.
2002 EstablishedBiosteed Gene Expression Tech. Co., Ltd.as its branch for research and development.
1999 Commercialized TOPNEUTERTM (rHuG-CSF) in China.
1997 Commercialized TOPLEUCONTM (rHuGM-CSF) in China, as the first domestic GM-CSF, afterward it was awarded the Key National Torch Project.
1996 Founded XIAMEN AMOYTOP BIOTECH CO., LTD.