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Beijing Hotgen Biotech Co., Ltd.
Beijing Hotgen Biotech Co., Ltd.
About Hotgen

Company Profile

Beijing Hotgen Biotech Co., Ltd. (hereinafter referred to as “Hotgen Biotech”) was founded in 2005. It is a high-tech enterprise focusing on the biopharmaceutical field and was listed on the STAR Market of the Shanghai Stock Exchange in September 2019 (Stock Code: 688068).


The Institute of Future Technology, our innovation incubation platform, is dedicated to transforming advanced scientific discoveries into products. Its focus areas include nucleic acid drugs, antibody drugs, and biotechnology health and beauty consumer products. Among its breakthroughs, the world’s first antibody drug for myocardial infarction emergency treatment has obtained dual IND approvals in China and the United States, as well as FDA Fast Track designation.


Hotgen Biotech offers a comprehensive IVD product portfolio, ranging from high-precision Up-Converting POCT devices (UPT series) to compact, mid-sized, and fully automated single-test chemiluminescence analyzers (MQ60 series). For high-throughput testing, we provide fully automated chemiluminescence platforms (C800 series). The product menu includes over 100 parameters across key disease areas such as thyroid function, reproductive hormones, cardiovascular diseases, inflammation, oncology, liver diseases, and drug of abuse (DOA) testing.

Hotgen Biotech’s products have obtained major registrations and filings in multiple countries, including China NMPA, EU CE, Germany BfArM, and UK MHRA, with over 600 overseas certificates in total, among which more than 90 are EU CE IVDR certificates. The company has established subsidiaries and offices in key markets such as Europe, India, and the Americas, providing better services to global customers and continuously expanding its international business footprint.


Guided by the mission of “Developing Biotechnology and Benefiting Human Health,” Hotgen Biotech is committed to building a comprehensive industry chain, spanning from specialized diagnostics to innovative pharmaceuticals.


Honor Certificates

eu quality management system certificate
mdsap certificate
mdsap certificate
iso 13485
iso 13485

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Milestone

  • 2005

    Founded.


  • 2006

    Approved:

    Beijing Patent Pilot Enterprise;

    Beijing high-tech enterprise.


  • 2008

    The patented alpha-fetoprotein allogeneic kit was approved by SFDA for marketing.


  • 2009

    Approved as Zhongguancun High-tech Enterprise.


  • 2010

    Approved as a national high-tech enterprise;

    The patented GP73 test kit was approved by SFDA for marketing.


  • 2011

    China's first luminescence fully quantitative immunoassay analyzer - UPT and supporting reagents were successfully launched.


  • 2012

    Beijing Medical Device Quality Management Demonstration Enterprise.


  • 2014

    Top 100 high-growth enterprises in Zhongguancun

    Approved as "Beijing Key Laboratory of Biological Emergency and Clinical POCT".


  • 2015

    Won the second prize of National Technology Invention Award.


  • 2016

    Beijing Biopharmaceutical G20 Enterprise;

    Ranked first in Beijing’s high-tech achievements transformation biotechnology.


  • 2017

    Magnetic particle chemiluminescence products are fully launched;

    Drug abuse detection reagents are launched;

    The second generation AFP-L3% reagent is fully launched.


  • 2018

    Sungen was established to focus on the research and development of antibody drugs.

  • 2019

    The multi-index diagnostic system for early diagnosis of liver cirrhosis and liver cancer (GP 73, AFP-L3%, DCP) won the China In Vitro Diagnostic Annual Outstanding Innovative Product Gold Award;

    Listed on the Science and Technology Innovation Board.


  • 2020

    Completed the development of new coronavirus detection kit in 45 days;

    COVID-19 UPT antibody detection kit approved.


  • 2021

    Nature published an article:

    GP73 is a TBC-domain Rab GTPase-activating

    protein contributing to the pathogenesis of

    non-alcoholic fatty liver disease without obesity.

    Won the "2021 Most Valuable Science and Technology Innovation Board Listed Company";

    Youngen was established to focus on nucleic acid drugs.


  • 2022

    Nature published two articles:

    GP73 is a glucogenic hormone contributing to SARS-CoV-2-induced hyperglycemia;

    GP73 links SARS-CoV-2 infection with dysglycaemia.

    "Extracellular vesicle extraction kit" and "fully automatic sample processing system" were authorized by the national invention patent;

    Yugen was established to focus on the research and development of live bacterial drugs, intestinal microorganisms and various metabolic and immune diseases.

    The fully automatic up-transfer luminescence immunoassay (UPT6800) won the APEC “Light of Innovation Innovation Outstanding Achievements Award”;

    Antigen self-testing reagents have been approved in many countries such as the European Union and the United States, and have successively supported epidemic prevention and control in Hong Kong, France, the United Kingdom and other places.


  • 2023

    First Prize of Beijing Science and Technology Progress Award 2023;

    The new headquarters of the Beijing company and the Langfang production plant were put into use.


  • 2024

    Nature published an article:

    Deficiency of ASGR1 promotes liver injury by increasing GP73-mediated hepatic

    endoplasmic reticulum stress.

    Self-developed sugar chain exosome GIyExo-Capture® technology platform;

    Obtained Japanese PCT patent;

    "2022 Private Science and Technology Development Contribution Award" First Prize for Science and Technology Innovation;

    The world's first! Sungen’s myocardial infarction emergency antibody drug SGC001 received Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA).


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Take Back

Corporate Values

  • Mission

    To develop biotechnology and benefit human health.


  • Vision

    To be recognized as an innovative, dedicated, and socially responsible biotechnology company that makes positive contributions to public health.


  • Core Values

    Products' quality determines the company's principle,

    Customers determine the company's accomplishments,

    Talents determine the company's prospect,

    Innovation determines the company's future.


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