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Hotgen

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Namestring
Hotgen
Legal namestring
北京热景生物技术股份有限公司
Websiteurl
hotgen.com.cn
Company typeenum
Public
Founded yearint
2005
Descriptiontext

Hotgen Biotech (688068.SH) is a Beijing-headquartered in vitro diagnostics (IVD) platform that also operates an early-stage innovative drug pipeline. The company's diagnostic business is anchored on four integrated technology platforms: magnetic microparticle chemiluminescence immunoassay (CLIA, including MQ60, C2000, C900, C3000, C6000 analyzers), up-converting phosphor technology (UPT) for point-of-care testing, the proprietary GlyExo-Capture sugar-chain exosome capture technology, and multi-omics assays covering protein biomarkers, DNA methylation (利为平®, six-gene methylation panel) and microRNA detection. Its flagship commercial theme is the "National Liver Health Project" (国人肝健康工程), a hepatitis-to-hepatocellular carcinoma diagnostic continuum spanning the AFP/AFP-L3%/DCP liver cancer trio, CK18-M30/M65 fatty liver assay, GP73, HBV-LP, and the AI-driven C-GALAD risk model deployed across roughly 60 tier-3 hospitals.

Beyond diagnostics, Hotgen has incubated an original drug pipeline led by its controlled subsidiary Shunyu Medical (舜景医药) and minority affiliate Yaoking Gene (尧景基因). SGC001, a global first-in-class anti-S100A8/A9 antibody for acute myocardial infarction, received simultaneous NMPA and FDA IND approval in 2024 and FDA Fast Track Designation in March 2025, entering Phase II in January 2026. Shunyu's pipeline also includes SGT003 (a NexTreg bispecific antibody, NMPA IND accepted April 2026), an SG Linker-Payload ADC platform (PCT published), and Yaoking's Kardia Shuttle cardiac-targeted siRNA delivery platform. Revenue is generated primarily through B2B sales of IVD reagents and instruments to hospitals, customs and disease-control authorities, and food-safety laboratories across approximately 26 Chinese regional offices, with international distribution via the India subsidiary (since 2019) and channel partners spanning Southeast Asia, Central Asia, the Middle East, Africa, Latin America and Europe (over 600 overseas certifications).

Short descriptiontext

Hotgen (688068.SH) is a Beijing-based IVD company that develops chemiluminescence, UPT POCT, and exosome-based diagnostic platforms for liver disease, infectious disease, and public safety, and is incubating a novel antibody and siRNA drug pipeline via subsidiary Shunyu Medical and affiliate Yaoking Gene.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
1,001–5,000
akta.pro rankint
HeadquartersDaxing, China
HQ citystring
Daxing
HQ countrystring
China
HQ regionstring
Asia
Markets served

Serves global market

Offices9 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
in vitro diagnostics, chemiluminescence immunoassay, liver disease diagnostics, point-of-care testing, immunodiagnostic reagents
Industry3 codes
1Oncology Diagnostics (tumor profiling, MRD, liquid biopsy)
CodeHLAAALAEPrimaryYes
2Molecular Diagnostics (PCR/NAAT/NGS-based IVD)
CodeHLAHAAADPrimaryNo
3Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays)
CodeHLAAALALPrimaryNo
NAICS code3 codes
  • In-Vitro Diagnostic Substance Manufacturing325413
  • Analytical Laboratory Instrument Manufacturing334516
  • Research and Development in Biotechnology (except Nanobiotechnology)541714
SIC code3 codes
  • In Vitro & In Vivo Diagnostic Substances2835
  • Laboratory Analytical Instruments3826
  • Services-Commercial Physical & Biological Research8731
Product category
In Vitro Diagnostics (IVD)
Social media profiles1 record
GTM motion3 records

Each record includes

Type, Description, Source

Revenue model3 records
1IVD Reagent and Instrument Sales (Clinical Diagnostics)
TypeHardware Sales
Description

Hotgen's primary revenue stream from the sale of in vitro diagnostic reagents and instruments for clinical applications including liver disease (hepatitis, liver cancer), cardiovascular disease, infectious diseases, and cytokine testing. Products include UPT POCT systems, MQ60 single-test chemiluminescence platforms, and large automated chemiluminescence analyzers (C2000, C3000, C6000, C900). Revenue peaked during COVID years (RMB 5.37B in 2021) and returned to non-COVID normalized base of ~RMB 541M in 2023, with non-COVID business growing 31.82% YoY to RMB 408M.

hotgen.com.cn
2Public Safety and Food Safety Testing Products
TypeHardware Sales
Description

Sale of POCT instruments and reagents for border inspection (customs), disease control, biological counter-terrorism, and food safety testing. Includes UPT-based portable detectors for mycotoxins, pathogens, and biothreat agents used by customs authorities and food inspection agencies.

hotgen.com.cn
3Pharmaceutical Pipeline (Innovative Drugs)
TypeOne Time License
Description

Future revenue stream from proprietary innovative drugs developed through controlled subsidiary Shunyu Medical (急性心梗抗体SGC001 in Phase II) and affiliated companies. SGC001 targets the large unmet cardiovascular emergency market and could generate significant revenue upon regulatory approval.

hotgen.com.cn
Marketing channels7 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels5 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 of 6 records shown
1舜景医药 (Shunjing Biomedical)
Description

Strategic holding subsidiary focused on innovative antibody drug discovery and development, developing first-in-class drugs for cardiovascular diseases and tumors

hotgen.com.cn
+5 more records
Core offering1 text field

Hotgen develops, manufactures, and sells in vitro diagnostic (IVD) instruments and reagent kits built on four integrated technology platforms: Magnetic Microparticle Chemiluminescence Immunoassay (CLIA), Up-Converting Phosphor Technology (UPT) for point-of-care testing, GlyExo-Capture® sugar-chain exosome capture, and multi-omics DNA methylation/microRNA detection. The company also operates a comprehensive liver disease diagnostic ecosystem (国人肝健康工程) covering hepatitis-to-liver-cancer screening and is developing an innovative drug pipeline through controlled subsidiary Shunjing Biomedical, including first-in-class antibody drug SGC001 for acute myocardial infarction.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 6 values shown
  • C-GALAD model improves early liver cancer detection sensitivity by >40% compared to ultrasound + AFP alone in high-risk populations (直径<3cm early HCC detection rate)
+5 more records
Product overview1 text field

Hotgen (北京热景生物技术股份有限公司, stock code: 688068.SH) is a Beijing-based, high-tech biomedical enterprise founded in 2005 and listed on the STAR Market in 2019. Its product portfolio spans a multi-tiered immunodiagnostics platform (from POCT to high-throughput automated CLIA), liver disease comprehensive management (国人肝健康工程), and an expanding AI-powered innovation drug pipeline. The diagnostic platform consists of: (1) the UPT (up-converting phosphor luminescent) POCT series — handheld UPT, UPT-3A 1200/1800, UPT 2800 for rapid quantitation of infectious, cardiac, and tumor markers; (2) the MQ60 single-dish and C-series automated CLIA systems (MQ60 Smart/Plus/AUTO/ProB, C2000, C900, C3000, C6000) for medium-to-high throughput hepatitis, tumor, and cytokine testing; (3) the LAS-H2 mini bio-immune pipeline with HOTminds AI agent and built-in C-GALAD model; and (4) the C2100 desktop full-blood analyzer for emergency settings. Diagnostic reagent menus include the liver cancer three-marker panel (AFP/AFP-L3%/DCP) powering the C-GALAD HCC risk models (I and II), CK18-M30/M65 fatty liver panel, 14-cytokine panel, small molecule sandwich assay series (thyroid/sex/bone metabolism), and the GlyExo-Capture® exosome microRNA platform (EXO-01). AI-powered products include the TA-SEEK target evaluation platform, the 肝馨为你 liver health management AI model, and the 利为平® six-gene HCC methylation kit with AI analysis software. The innovation drug segment is led by subsidiary 舜景医药 (strategically controlled) with the global first-in-class acute myocardial infarction antibody SGC001 (Phase II), ADC Linker-Payload platform, and NexTreg™ bispecific antibody platform (SGT003); and by subsidiary 尧景基因 (minority stake) with the Kardia Shuttle™ cardiac-targeted siRNA delivery platform and STTTM extrahepatic delivery technology.

Product and service16 records
1Up-Converting Phosphor Immunoassay Analyzer Series (上转发光免疫分析仪 UPT系列)
CategoryClinical Diagnostics — POCT Immunoassay Platform
Description

Point-of-care up-converting phosphor luminescent (UPT) immunoassay platform for rapid quantitative detection of infectious diseases, cardiac markers, tumor markers, and food safety toxins. Available in handheld (手持UPT), benchtop (UPT-3A 1200/1800), and larger formats (UPT 2800). Built on rare-earth nanoparticle luminescence with infrared laser excitation.

2Chemiluminescence Immunoassay System — MQ60 and C-Series (化学发光免疫分析系统 MQ60/C系列)
CategoryClinical Diagnostics — Automated Immunoassay Platform
Description

Magnetic particle chemiluminescence immunoassay (CLIA) platforms including single-dish MQ60 series (MQ60 Smart, MQ60 Plus, MQ60 AUTO, MQ60 ProB), medium-throughput C2000, and high-throughput C900/C3000/C6000 systems for clinical diagnostics across hepatitis, tumor, cardiovascular, and cytokine markers.

3LAS-H2 Mini Bio-Immune Automated Pipeline (LAS-H2 mini生免流水线)
CategoryClinical Diagnostics — Integrated Immunoassay Platform
Description

Mini bio-immune automated pipeline integrating biochemistry and CLIA modules. Equipped with HOTminds AI research assistant and built-in C-GALAD HCC risk early-warning model. Covers liver disease, fatty liver, lipid and other comprehensive immunoassay menu. Features automated sample processing with AI visual recognition for hemolyzed, lipemic, and icteric samples.

4C2100 Desktop Full-Blood Chemiluminescence Immunoassay Analyzer (C2100全自动化学发光免疫分析仪)
CategoryClinical Diagnostics — Emergency Immunoassay Platform
Description

Desktop full-blood chemiluminescence analyzer designed for emergency testing. Achieves 12-minute full-blood rapid detection with automatic cap-opening and mixing and HCT calibration. Supports direct original blood sample loading, ideal for chest pain centers, stroke centers, and emergency departments.

5GlyExo-Capture® Sugar-Chain Exosome Capture Technology Platform (糖捕获技术 / 外泌体miRNA检测平台)
CategoryClinical Diagnostics — Exosome-based Cancer Early Detection
Description

Glycan-based exosome capture technology platform for isolating disease-specific exosomes. Powers cancer early diagnosis reagents for pancreatic cancer, liver cancer, gastric cancer, prostate cancer, urothelial carcinoma, and Alzheimer's disease. Achieves 11-minute sample-to-result. Includes the EXO-01 fully automated exosome microRNA detection instrument.

6TA-SEEK Target Evaluation and Analysis AI Platform (TA-SEEK靶点评估与分析AI平台)
CategoryAI-driven Pharmaceutical R&D Platform
Description

AI-powered drug target evaluation and decision support platform using multi-omics databases, clinical drug research data, and multimodal large language model. Provides natural language query for target-disease association, mining of genetic and omics evidence, and comprehensive developability and safety risk assessment. Registered software (2025SR2213571).

7Gan Xin Wei Ni Liver Cancer High-Risk Population Management AI Model (肝霖为你)
CategoryAI-driven Liver Health Management Tool
Description

Multi-modal AI assistant for liver cancer high-risk population management deployed as a WeChat mini-program. Integrates OCR report parsing, C-GALAD HCC risk assessment, personalized screening interval recommendations, imaging report intelligent interpretation, and 24/7 liver health Q&A powered by professional liver disease knowledge base.

8CK18-M30/M65 Chemiluminescence Reagent Kit (CK18-M30/M65脂肪肝二项)
CategoryClinical Diagnostics — Liver Disease Reagent
Description

Cytokeratin-18 fragment detection reagents (CK18-M30 and CK18-M65) using chemiluminescence for non-invasive assessment of metabolic-associated fatty liver disease (MAFLD/MASH). CK18-M30 reflects hepatocyte apoptosis; CK18-M65 reflects total cell death. First chemiluminescence registration certificate for CK18 in China.

9Food Safety Testing Solutions (食品安全检测 — 真菌毒素/微生物)
CategoryFood Safety Testing
Description

Food safety rapid testing solutions based on UPT platform for detecting aflatoxin B1/M1, zearalenone, vomitoxin, Ochratoxin, Fumonisin, T-2 toxin, and foodborne pathogens including Salmonella, Listeria monocytogenes, E. coli O157, and Staphylococcus aureus.

10Drug, Customs, and Biodefense Detection Solutions (毒品/海关/生物反恐检测)
CategoryPublic Safety and Biosecurity Testing
Description

UPT-based rapid detection platforms for drug testing, customs/port disease control, and biological counter-terrorism. Instruments include portable UPT analyzers and mobile biological rapid detection systems for pathogens including Yersinia pestis, Bacillus anthracis, cholera, Ebola, and others. UPT-3A series instruments have been included in port biological hazard monitoring equipment standards.

11Liver Cancer Three-Marker Panel (AFP/AFP-L3%/DCP) (肝癌三项)
CategoryClinical Diagnostics — Liver Cancer Reagent
Description

Liver cancer three-marker panel (AFP, AFP-L3%, DCP) run on automated CLIA systems for early hepatocellular carcinoma diagnosis. The C-GALAD combined model significantly improves early HCC detection sensitivity and specificity. Supported by the 13th Five-Year National Science and Technology Major Project.

12National Liver Health Project / Liver Disease Comprehensive Diagnostic System (国人肝健康工程)
CategoryClinical Diagnostics — Liver Disease Comprehensive Solution
Description

Comprehensive liver health management program covering hepatitis-to-liver cancer disease progression monitoring. Includes the liver cancer three-marker panel (AFP/AFP-L3%/DCP), HBV RNA, GP73, liver fibrosis panel, CK18 fatty liver panel, and the C-GALAD HCC risk model. Provides complete liver health screening from hepatitis to liver cancer.

13Li-Wei-Ping® Six-Gene Methylation HCC Detection Kit (利为平®肝癌甲基化六靶点检测试剂盒)
CategoryClinical Diagnostics — Liver Cancer Reagent
Description

Six-gene methylation PCR fluorescent probe detection kit (TSPYL5, RASSF1A, DAB2IP, OTX1, PTPN18, HIST1H3G) for hepatocellular carcinoma early diagnosis. Class III NMPA registration. Detects HCC across all stages with high sensitivity, including early-stage and micro-HCC. Compensates for AFP-negative high-risk population screening gaps.

14SGC001 — Acute Myocardial Infarction Antibody Drug (全球首创心梗急救抗体药 SGC001)
CategoryInnovative Drug — Antibody Therapeutics
Description

World's first-in-class acute myocardial infarction antibody drug developed by subsidiary Shunjing Biomedical. Targets the S100A8/A9 pathway. Entered Phase II clinical trial in January 2026 with 20+ participating centers in China. Received simultaneous NMPA and FDA IND approval and FDA Fast Track Designation.

15Microfluidic Diagnostic Platform (微流控平台)
CategoryClinical Diagnostics — Microfluidic Platform
Description

Microfluidic diagnostic technology platform for compact, automated sample processing and detection at point-of-care settings.

16Integrated Molecular Diagnostic Systems (一体机/分子诊断)
CategoryClinical Diagnostics — Molecular Diagnostic Platform
Description

Integrated molecular diagnostic systems and gene detection platforms covering nucleic acid-based testing for infectious diseases, genetic markers, and precision medicine applications.

Scale indicator9 records

Each record includes

Type, Value, Description, Source

Partnership20 partners
1北京市心肺血管疾病研究所 (Beijing Institute of Cardiopulmonary Vascular Disease Research)
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-06-01
Description

Co-founded the 'Cardiovascular Disease Biological Innovative Drug R&D Joint Laboratory' with Shunyu Medical. Prof. Du Jie from this institute co-developed SGC001 and serves as a key clinical investigator. The institute is also a co-founding member of the Beijing Key Laboratory for Cardiovascular Antibody and Macromolecule Innovative Drug R&D.

hotgen.com.cn
2南京大学医学院附属鼓楼医院 (Drum Tower Hospital, Nanjing University)
Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2026-06-01
Description

Drum Tower Hospital research team, led by Prof. Li Jie, published research at AASLD 2024 on PRO-C3 and GP73 combined liver fibrosis non-invasive scoring, selected as 'Poster of Distinction.' The hospital collaborated on multi-center studies validating Hotgen's liver disease diagnostic markers.

hotgen.com.cn
3苏州市第五人民医院 (Suzhou Fifth People's Hospital)
Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2026-06-01
Description

Prof. Zhu Li's team from Suzhou Fifth People's Hospital collaborated on AASLD 2024 research validating PRO-C3 and GP73 for CHB liver fibrosis diagnosis.

hotgen.com.cn
4中国肝炎防治基金会 (China Hepatitis Prevention and Treatment Foundation)
Strategic tierCoreTypeGTM or Marketing PartnerAnnounced on2026-06-01
Description

Hotgen partnered with the foundation to launch the '国人肝健康工程项目' (National Liver Health Project) in 2023, providing free liver cancer screening to high-risk populations. Project aims to improve early liver cancer diagnosis rate in China and has screened over 130,000 individuals.

hotgen.com.cn
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-01-01
Description

Hotgen holds a majority stake in Sungen Biomed (热景生物控股企业). Sungen is developing multiple innovative drug pipelines including SGC001 (acute MI antibody, Phase II), SGT003 (bispecific antibody, IND submitted), and an ADC platform (SG Linker-Payload, PCT published).

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-01-01
Description

Hotgen holds a minority stake in Youngen Biotech, which highlighted China's emerging leadership in RNAi therapeutics and presented its Kardia Shuttle™ cardiac-targeted delivery platform at the 2026 China FIC Innovation Summit.

7ZFIC Alliance (中关村FIC创新药战略发展联盟)
Strategic tierCoreTypeGTM or Marketing PartnerAnnounced on2026-01-01
Description

Hotgen subsidiary Shunyu Medical participated in the ZFIC Alliance-organized '2026 China FIC Innovation and Collaboration Summit' in San Francisco alongside J.P. Morgan Healthcare Conference, showcasing R&D platforms and clinical pipelines to the global biopharma industry.

hotgen.com.cn
8山东省医学会 (Shandong Medical Association)
Strategic tierMinorTypeGTM or Marketing PartnerAnnounced on2025-10-01
Description

Hotgen supported the academic symposium 'Innovation Diagnosis, Value Healthcare' at the Second Yellow River Laboratory Medicine Conference, presenting new diagnostic technologies including C-GALAD, CK18, cytokines, and small molecule sandwich assay.

hotgen.com.cn
9北京大学医学人文学院 (Peking University Medical Humanities College)
Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2025-06-01
Description

Hotgen and Peking University Medical Humanities College co-established an 'Innovation Practice Teaching Base' to provide students with practical experience in biomedical research and diagnostics, supporting talent development.

hotgen.com.cn
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-05-01
Description

Southern Hospital is the lead institution for the National Key R&D Program 'Disease-Specific Exosome Detection Technology Research and Prototype Development.' Hotgen is a sub-project collaborating unit, responsible for developing pancreatic cancer exosome diagnostic reagents and detection platforms in partnership with Southern Hospital, CAMS Cancer Hospital, BUCT, and Peking Union Medical College Hospital.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-03-01
Description

Shunyu Medical co-developed SGC001 with Anzhen Hospital. Prof. Du Jie from Anzhen Hospital leads the clinical development. Anzhen is the project lead unit for the 2026 National Science and Technology Major Project for innovative drug R&D, with Shunyu as a major participant. Anzhen Hospital serves as lead PI site for SGC001 Phase II.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-03-01
Description

Shunyu Medical signed strategic cooperation agreement with JOINN Biologics for integrated drug development services. JOINN will provide full-service CMC support from early drug discovery through IND filing, including process development and GMP manufacturing.

Strategic tierCoreTypeImplementation/ SI/ Consulting PartnerAnnounced on2025-03-01
Description

Shunyu Medical signed strategic cooperation with JOINN Staidson for nonclinical CRO services including pharmacology, pharmacokinetics, and toxicology studies to support IND applications.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-01-03
Description

Hotgen signed a technology transfer agreement with Youan Hospital for the 'MAFLD key gene polymorphism joint detection reagent kit' developed by Prof. Zhang Jing's team. Youan is also collaborating on a serum CK18 diagnostic study for MASH. Hotgen donated RMB 1M to Youan's disaster relief fund.

15中国食品药品检定研究院 (NIFDC, National Institutes for Food and Drug Control)
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-01-01
Description

NIFDC serves as the regulatory validation authority for Hotgen's diagnostic products and is a collaborating unit in the National Key R&D Program for disease-specific exosome detection. C-GALAD model products have passed NIFDC registration validation.

hotgen.com.cn
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-01-01
Description

Peking Union Medical College Hospital collaborated with Hotgen on the National Key R&D Program for disease-specific exosome detection. Hospital hosted international medical expert delegations visiting Hotgen for academic exchange on innovative IVD technologies.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-01-01
Description

CAMS Cancer Hospital is a collaborating unit in the National Key R&D Program for disease-specific exosome detection, working with Hotgen on pancreatic cancer exosome diagnostic development.

18北京化工大学 (Beijing University of Chemical Technology, BUCT)
Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2025-01-01
Description

BUCT is a collaborating unit in the National Key R&D Program for disease-specific exosome detection, contributing to technology development with Hotgen.

hotgen.com.cn
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-01-01
Description

Xuanwu Hospital serves as the lead PI site for AA001 (anti-AD antibody, Hotgen invested company Zhiyuan Bio) Phase Ib clinical trial, with Prof. Tang Yi and Prof. Wei Cuibai as lead investigators.

20深圳智源生物医药有限公司 (Shenzhen Zhiyuan Biomedical Co., Ltd.)
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2023-10-01
Description

Hotgen co-founded the '国人脑健康工程' (National Brain Health Project) joint laboratory with Zhiyuan Bio, focusing on AD and Parkinson's disease diagnostics and treatment. Hotgen invested RMB 40M in Zhiyuan in 2023 to strengthen its AD diagnostic business. Zhiyuan's subsidiary is developing AA001 anti-AD antibody (Phase Ib ongoing) and other neurodegenerative disease drugs.

hotgen.com.cn
Recent move8 records

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Date, Type, Title, Description, Source

Expansion highlight7 records

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Type, Description

Peers10 records
TypeDirect peer
Description

Shenzhen-headquartered Chinese IVD company competing head-to-head with Hotgen in chemiluminescence immunoassay platforms (MAGLUMI series) for clinical diagnostics including hepatitis, tumor markers, and infectious diseases. Closest direct competitor by technology stack (CLIA), product menu breadth, and target customer base (tier-2/3 hospitals in China and international markets).

TypeDirect peer
Description

Zhengzhou-based Chinese IVD major with a comprehensive immunoassay, microbiology, and clinical chemistry menu. Competes with Hotgen in chemiluminescence platforms (Aurora series) and broad immunodiagnostics for hospital laboratories, with overlapping focus areas in hepatitis and tumor markers.

TypeBroad incumbent
Description

China's largest medical device and IVD group with a vastly broader portfolio including patient monitoring, in-vitro diagnostics, and medical imaging. Through its CL-series chemiluminescence analyzers (CL-6000/8000) and reagents, Mindray competes with Hotgen in hospital IVD purchasing decisions, but operates at much larger scale with diversified revenue streams beyond diagnostics.

TypeDirect peer
Description

Sun Yat-sen University-affiliated Chinese molecular diagnostics company specializing in PCR-based infectious disease testing, HPV screening, and nucleic acid diagnostics. Comparable to Hotgen in molecular diagnostics focus areas and hospital sales channels, with stronger positioning in infectious disease molecular testing.

TypeDirect peer
Description

Shenzhen-headquartered genomics and diagnostics player with capabilities spanning NIPT, oncology liquid biopsy, and infectious disease molecular diagnostics. Comparable to Hotgen in oncology diagnostics/liquid biopsy ambitions and global footprint, though with materially larger scale and a different platform mix (sequencing-led vs. immunoassay).

TypeBroad incumbent
Description

Global IVD leader with Elecsys/Cobas chemiluminescence platforms and broad hepatitis/tumor marker menus comparable to Hotgen's C-series. Represents the global benchmark competition for liver disease diagnostics and immunodiagnostics in international markets where Hotgen targets expansion via its 600+ certifications.

TypeBroad incumbent
Description

Global IVD leader with Architect/i-STAT/Alinity immunoassay and point-of-care platforms overlapping Hotgen's CLIA and UPT POCT offerings. Comparable in hepatitis serology and cardiac marker menus, and a major competitor for international expansion opportunities in emerging markets.

TypeDirect peer
Description

Guangdong-based Chinese IVD player focused on POCT, immunofluorescence, and chemiluminescence platforms. Comparable to Hotgen in POCT competitive dynamics and rapid testing technology, especially for infectious disease and cardiac markers, and a direct competitor in lower-tier hospital channels.

TypeEmerging player
Description

China's largest independent clinical laboratory service provider that operates as a customer and partial competitor to IVD manufacturers like Hotgen. Comparable in serving the diagnostic testing needs of Chinese hospitals, with material overlap in liver disease, infectious disease, and oncology testing demand drivers.

TypeOthers
Description

Leading Chinese innovative drug developer with FDA-approved biologics and a deep oncology pipeline. Comparable to Hotgen's Shunjing Biomedical subsidiary for the innovative drug pipeline dimension — both are Chinese biotechs pursuing first-in-class antibody therapeutics with global regulatory ambitions (NMPA + FDA). Innovent serves as a benchmark for valuation of innovative Chinese biologics.

Market position
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Named customers6 records

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Segment6 records

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Ideal customer profile3 records

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Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
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No

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AI capability7 records

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Profiles11 records

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Subsidiaries8 records

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Funding rounds3 records

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Investors3 records

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Funding detail is available on the Subscription and Enterprise plan.Contact sales →

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Investment2 records

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M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Hotgen

In Vitro Diagnostics (IVD)hotgen.com.cn

Hotgen (688068.SH) is a Beijing-based IVD company that develops chemiluminescence, UPT POCT, and exosome-based diagnostic platforms for liver disease, infectious disease, and public safety, and is incubating a novel antibody and siRNA drug pipeline via subsidiary Shunyu Medical and affiliate Yaoking Gene.

What Hotgen does

Hotgen Biotech (688068.SH) is a Beijing-headquartered in vitro diagnostics (IVD) platform that also operates an early-stage innovative drug pipeline. The company's diagnostic business is anchored on four integrated technology platforms: magnetic microparticle chemiluminescence immunoassay (CLIA, including MQ60, C2000, C900, C3000, C6000 analyzers), up-converting phosphor technology (UPT) for point-of-care testing, the proprietary GlyExo-Capture sugar-chain exosome capture technology, and multi-omics assays covering protein biomarkers, DNA methylation (利为平®, six-gene methylation panel) and microRNA detection. Its flagship commercial theme is the "National Liver Health Project" (国人肝健康工程), a hepatitis-to-hepatocellular carcinoma diagnostic continuum spanning the AFP/AFP-L3%/DCP liver cancer trio, CK18-M30/M65 fatty liver assay, GP73, HBV-LP, and the AI-driven C-GALAD risk model deployed across roughly 60 tier-3 hospitals.

Beyond diagnostics, Hotgen has incubated an original drug pipeline led by its controlled subsidiary Shunyu Medical (舜景医药) and minority affiliate Yaoking Gene (尧景基因). SGC001, a global first-in-class anti-S100A8/A9 antibody for acute myocardial infarction, received simultaneous NMPA and FDA IND approval in 2024 and FDA Fast Track Designation in March 2025, entering Phase II in January 2026. Shunyu's pipeline also includes SGT003 (a NexTreg bispecific antibody, NMPA IND accepted April 2026), an SG Linker-Payload ADC platform (PCT published), and Yaoking's Kardia Shuttle cardiac-targeted siRNA delivery platform. Revenue is generated primarily through B2B sales of IVD reagents and instruments to hospitals, customs and disease-control authorities, and food-safety laboratories across approximately 26 Chinese regional offices, with international distribution via the India subsidiary (since 2019) and channel partners spanning Southeast Asia, Central Asia, the Middle East, Africa, Latin America and Europe (over 600 overseas certifications).

Hotgen firmographics

Firmographics
Name
Hotgen
Legal name
北京热景生物技术股份有限公司
Website
https://hotgen.com.cn
Company type
Public
Founded year
2005
Operating status
Operating
Headcount range
1,001–5,000 employees
Short description
Hotgen (688068.SH) is a Beijing-based IVD company that develops chemiluminescence, UPT POCT, and exosome-based diagnostic platforms for liver disease, infectious disease, and public safety, and is incubating a novel antibody and siRNA drug pipeline via subsidiary Shunyu Medical and affiliate Yaoking Gene.
Ownership category
akta.pro rank

Hotgen industry classification

Industry
Product category
In Vitro Diagnostics (IVD)
NAICS
In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
SIC
In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Services-Commercial Physical & Biological Research (8731)
akta.pro primary industry
Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
akta.pro secondary industries
Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

  • In vitro diagnostics
  • Chemiluminescence immunoassay
  • Liver disease diagnostics
  • Point-of-care testing
  • Immunodiagnostic reagents

Where Hotgen is headquartered

Location

Headquarters

HQ city
Daxing
HQ country
China
HQ region
Asia

Offices9 records

Markets served

Hotgen business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Supply Chain, Operations, Marketing or Sales, Infrastructure

Revenue model

  1. IVD Reagent and Instrument Sales (Clinical Diagnostics): Hotgen's primary revenue stream from the sale of in vitro diagnostic reagents and instruments for clinical applications including liver disease (hepatitis, liver cancer), cardiovascular disease, infectious diseases, and cytokine testing. Products include UPT POCT systems, MQ60 single-test chemiluminescence platforms, and large automated chemiluminescence analyzers (C2000, C3000, C6000, C900). Revenue peaked during COVID years (RMB 5.37B in 2021) and returned to non-COVID normalized base of ~RMB 541M in 2023, with non-COVID business growing 31.82% YoY to RMB 408M.
  2. Public Safety and Food Safety Testing Products: Sale of POCT instruments and reagents for border inspection (customs), disease control, biological counter-terrorism, and food safety testing. Includes UPT-based portable detectors for mycotoxins, pathogens, and biothreat agents used by customs authorities and food inspection agencies.
  3. Pharmaceutical Pipeline (Innovative Drugs): Future revenue stream from proprietary innovative drugs developed through controlled subsidiary Shunyu Medical (急性心梗抗体SGC001 in Phase II) and affiliated companies. SGC001 targets the large unmet cardiovascular emergency market and could generate significant revenue upon regulatory approval.

Go-to-market motion3 records

Distribution channels5 records

Marketing channels7 records

Hotgen product offering

Product offering

Core offering

Hotgen develops, manufactures, and sells in vitro diagnostic (IVD) instruments and reagent kits built on four integrated technology platforms: Magnetic Microparticle Chemiluminescence Immunoassay (CLIA), Up-Converting Phosphor Technology (UPT) for point-of-care testing, GlyExo-Capture® sugar-chain exosome capture, and multi-omics DNA methylation/microRNA detection. The company also operates a comprehensive liver disease diagnostic ecosystem (国人肝健康工程) covering hepatitis-to-liver-cancer screening and is developing an innovative drug pipeline through controlled subsidiary Shunjing Biomedical, including first-in-class antibody drug SGC001 for acute myocardial infarction.

Product overview

Hotgen (北京热景生物技术股份有限公司, stock code: 688068.SH) is a Beijing-based, high-tech biomedical enterprise founded in 2005 and listed on the STAR Market in 2019. Its product portfolio spans a multi-tiered immunodiagnostics platform (from POCT to high-throughput automated CLIA), liver disease comprehensive management (国人肝健康工程), and an expanding AI-powered innovation drug pipeline. The diagnostic platform consists of: (1) the UPT (up-converting phosphor luminescent) POCT series — handheld UPT, UPT-3A 1200/1800, UPT 2800 for rapid quantitation of infectious, cardiac, and tumor markers; (2) the MQ60 single-dish and C-series automated CLIA systems (MQ60 Smart/Plus/AUTO/ProB, C2000, C900, C3000, C6000) for medium-to-high throughput hepatitis, tumor, and cytokine testing; (3) the LAS-H2 mini bio-immune pipeline with HOTminds AI agent and built-in C-GALAD model; and (4) the C2100 desktop full-blood analyzer for emergency settings. Diagnostic reagent menus include the liver cancer three-marker panel (AFP/AFP-L3%/DCP) powering the C-GALAD HCC risk models (I and II), CK18-M30/M65 fatty liver panel, 14-cytokine panel, small molecule sandwich assay series (thyroid/sex/bone metabolism), and the GlyExo-Capture® exosome microRNA platform (EXO-01). AI-powered products include the TA-SEEK target evaluation platform, the 肝馨为你 liver health management AI model, and the 利为平® six-gene HCC methylation kit with AI analysis software. The innovation drug segment is led by subsidiary 舜景医药 (strategically controlled) with the global first-in-class acute myocardial infarction antibody SGC001 (Phase II), ADC Linker-Payload platform, and NexTreg™ bispecific antibody platform (SGT003); and by subsidiary 尧景基因 (minority stake) with the Kardia Shuttle™ cardiac-targeted siRNA delivery platform and STTTM extrahepatic delivery technology.

Differentiator

Problem solved

Functional benefit

Brands

  • 舜景医药 (Shunjing Biomedical): Strategic holding subsidiary focused on innovative antibody drug discovery and development, developing first-in-class drugs for cardiovascular diseases and tumors
  • 尧景基因 (Yaojing Gene)
  • 未来技术研究院 (Future Technology Research Institute)
  • 国人肝健康工程 (Chinese Liver Health Project)
  • GlyExo-Capture®
  • 利为平® (Li Wei Ping)

Products and services

  • Up-Converting Phosphor Immunoassay Analyzer Series (上转发光免疫分析仪 UPT系列) Point-of-care up-converting phosphor luminescent (UPT) immunoassay platform for rapid quantitative detection of infectious diseases, cardiac markers, tumor markers, and food safety toxins. Available in handheld (手持UPT), benchtop (UPT-3A 1200/1800), and larger formats (UPT 2800). Built on rare-earth nanoparticle luminescence with infrared laser excitation.
  • Chemiluminescence Immunoassay System — MQ60 and C-Series (化学发光免疫分析系统 MQ60/C系列) Magnetic particle chemiluminescence immunoassay (CLIA) platforms including single-dish MQ60 series (MQ60 Smart, MQ60 Plus, MQ60 AUTO, MQ60 ProB), medium-throughput C2000, and high-throughput C900/C3000/C6000 systems for clinical diagnostics across hepatitis, tumor, cardiovascular, and cytokine markers.
  • LAS-H2 Mini Bio-Immune Automated Pipeline (LAS-H2 mini生免流水线) Mini bio-immune automated pipeline integrating biochemistry and CLIA modules. Equipped with HOTminds AI research assistant and built-in C-GALAD HCC risk early-warning model. Covers liver disease, fatty liver, lipid and other comprehensive immunoassay menu. Features automated sample processing with AI visual recognition for hemolyzed, lipemic, and icteric samples.
  • C2100 Desktop Full-Blood Chemiluminescence Immunoassay Analyzer (C2100全自动化学发光免疫分析仪) Desktop full-blood chemiluminescence analyzer designed for emergency testing. Achieves 12-minute full-blood rapid detection with automatic cap-opening and mixing and HCT calibration. Supports direct original blood sample loading, ideal for chest pain centers, stroke centers, and emergency departments.
  • GlyExo-Capture® Sugar-Chain Exosome Capture Technology Platform (糖捕获技术 / 外泌体miRNA检测平台) Glycan-based exosome capture technology platform for isolating disease-specific exosomes. Powers cancer early diagnosis reagents for pancreatic cancer, liver cancer, gastric cancer, prostate cancer, urothelial carcinoma, and Alzheimer's disease. Achieves 11-minute sample-to-result. Includes the EXO-01 fully automated exosome microRNA detection instrument.
  • TA-SEEK Target Evaluation and Analysis AI Platform (TA-SEEK靶点评估与分析AI平台) AI-powered drug target evaluation and decision support platform using multi-omics databases, clinical drug research data, and multimodal large language model. Provides natural language query for target-disease association, mining of genetic and omics evidence, and comprehensive developability and safety risk assessment. Registered software (2025SR2213571).
  • Gan Xin Wei Ni Liver Cancer High-Risk Population Management AI Model (肝霖为你) Multi-modal AI assistant for liver cancer high-risk population management deployed as a WeChat mini-program. Integrates OCR report parsing, C-GALAD HCC risk assessment, personalized screening interval recommendations, imaging report intelligent interpretation, and 24/7 liver health Q&A powered by professional liver disease knowledge base.
  • CK18-M30/M65 Chemiluminescence Reagent Kit (CK18-M30/M65脂肪肝二项) Cytokeratin-18 fragment detection reagents (CK18-M30 and CK18-M65) using chemiluminescence for non-invasive assessment of metabolic-associated fatty liver disease (MAFLD/MASH). CK18-M30 reflects hepatocyte apoptosis; CK18-M65 reflects total cell death. First chemiluminescence registration certificate for CK18 in China.
  • Food Safety Testing Solutions (食品安全检测 — 真菌毒素/微生物) Food safety rapid testing solutions based on UPT platform for detecting aflatoxin B1/M1, zearalenone, vomitoxin, Ochratoxin, Fumonisin, T-2 toxin, and foodborne pathogens including Salmonella, Listeria monocytogenes, E. coli O157, and Staphylococcus aureus.
  • Drug, Customs, and Biodefense Detection Solutions (毒品/海关/生物反恐检测) UPT-based rapid detection platforms for drug testing, customs/port disease control, and biological counter-terrorism. Instruments include portable UPT analyzers and mobile biological rapid detection systems for pathogens including Yersinia pestis, Bacillus anthracis, cholera, Ebola, and others. UPT-3A series instruments have been included in port biological hazard monitoring equipment standards.
  • Liver Cancer Three-Marker Panel (AFP/AFP-L3%/DCP) (肝癌三项) Liver cancer three-marker panel (AFP, AFP-L3%, DCP) run on automated CLIA systems for early hepatocellular carcinoma diagnosis. The C-GALAD combined model significantly improves early HCC detection sensitivity and specificity. Supported by the 13th Five-Year National Science and Technology Major Project.
  • National Liver Health Project / Liver Disease Comprehensive Diagnostic System (国人肝健康工程) Comprehensive liver health management program covering hepatitis-to-liver cancer disease progression monitoring. Includes the liver cancer three-marker panel (AFP/AFP-L3%/DCP), HBV RNA, GP73, liver fibrosis panel, CK18 fatty liver panel, and the C-GALAD HCC risk model. Provides complete liver health screening from hepatitis to liver cancer.
  • Li-Wei-Ping® Six-Gene Methylation HCC Detection Kit (利为平®肝癌甲基化六靶点检测试剂盒) Six-gene methylation PCR fluorescent probe detection kit (TSPYL5, RASSF1A, DAB2IP, OTX1, PTPN18, HIST1H3G) for hepatocellular carcinoma early diagnosis. Class III NMPA registration. Detects HCC across all stages with high sensitivity, including early-stage and micro-HCC. Compensates for AFP-negative high-risk population screening gaps.
  • SGC001 — Acute Myocardial Infarction Antibody Drug (全球首创心梗急救抗体药 SGC001) World's first-in-class acute myocardial infarction antibody drug developed by subsidiary Shunjing Biomedical. Targets the S100A8/A9 pathway. Entered Phase II clinical trial in January 2026 with 20+ participating centers in China. Received simultaneous NMPA and FDA IND approval and FDA Fast Track Designation.
  • Microfluidic Diagnostic Platform (微流控平台) Microfluidic diagnostic technology platform for compact, automated sample processing and detection at point-of-care settings.
  • Integrated Molecular Diagnostic Systems (一体机/分子诊断) Integrated molecular diagnostic systems and gene detection platforms covering nucleic acid-based testing for infectious diseases, genetic markers, and precision medicine applications.

Quantifiable outcome

  • C-GALAD model improves early liver cancer detection sensitivity by >40% compared to ultrasound + AFP alone in high-risk populations (直径<3cm early HCC detection rate)
  • +5 more outcomes

Companies that use Hotgen

Customer profile

Named customers6 records

Segments6 records

Ideal customer profiles3 records

Hotgen technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature9 records

Hotgen partnerships and signals

Strategic signal

Partnerships

20 partnerships are on record, tiered core and minor.

  • 北京市心肺血管疾病研究所 (Beijing Institute of Cardiopulmonary Vascular Disease Research)coreStrategic or Co-development Partner · 1 June 2026Co-founded the 'Cardiovascular Disease Biological Innovative Drug R&D Joint Laboratory' with Shunyu Medical. Prof. Du Jie from this institute co-developed SGC001 and serves as a key clinical investigator. The institute is also a co-founding member of the Beijing Key Laboratory for Cardiovascular Antibody and Macromolecule Innovative Drug R&D.
  • 南京大学医学院附属鼓楼医院 (Drum Tower Hospital, Nanjing University)minorStrategic or Co-development Partner · 1 June 2026Drum Tower Hospital research team, led by Prof. Li Jie, published research at AASLD 2024 on PRO-C3 and GP73 combined liver fibrosis non-invasive scoring, selected as 'Poster of Distinction.' The hospital collaborated on multi-center studies validating Hotgen's liver disease diagnostic markers.
  • 苏州市第五人民医院 (Suzhou Fifth People's Hospital)minorStrategic or Co-development Partner · 1 June 2026Prof. Zhu Li's team from Suzhou Fifth People's Hospital collaborated on AASLD 2024 research validating PRO-C3 and GP73 for CHB liver fibrosis diagnosis.
  • 中国肝炎防治基金会 (China Hepatitis Prevention and Treatment Foundation)coreGTM or Marketing Partner · 1 June 2026Hotgen partnered with the foundation to launch the '国人肝健康工程项目' (National Liver Health Project) in 2023, providing free liver cancer screening to high-risk populations. Project aims to improve early liver cancer diagnosis rate in China and has screened over 130,000 individuals.
  • Sungen Biomed (舜景医药 — Hotgen controlled subsidiary)coreStrategic or Co-development Partner · 1 January 2026Hotgen holds a majority stake in Sungen Biomed (热景生物控股企业). Sungen is developing multiple innovative drug pipelines including SGC001 (acute MI antibody, Phase II), SGT003 (bispecific antibody, IND submitted), and an ADC platform (SG Linker-Payload, PCT published).
  • Youngen Biotech (优诺真生物)coreStrategic or Co-development Partner · 1 January 2026Hotgen holds a minority stake in Youngen Biotech, which highlighted China's emerging leadership in RNAi therapeutics and presented its Kardia Shuttle™ cardiac-targeted delivery platform at the 2026 China FIC Innovation Summit.
  • ZFIC Alliance (中关村FIC创新药战略发展联盟)coreGTM or Marketing Partner · 1 January 2026Hotgen subsidiary Shunyu Medical participated in the ZFIC Alliance-organized '2026 China FIC Innovation and Collaboration Summit' in San Francisco alongside J.P. Morgan Healthcare Conference, showcasing R&D platforms and clinical pipelines to the global biopharma industry.
  • 山东省医学会 (Shandong Medical Association)minorGTM or Marketing Partner · 1 October 2025Hotgen supported the academic symposium 'Innovation Diagnosis, Value Healthcare' at the Second Yellow River Laboratory Medicine Conference, presenting new diagnostic technologies including C-GALAD, CK18, cytokines, and small molecule sandwich assay.
  • 北京大学医学人文学院 (Peking University Medical Humanities College)minorStrategic or Co-development Partner · 1 June 2025Hotgen and Peking University Medical Humanities College co-established an 'Innovation Practice Teaching Base' to provide students with practical experience in biomedical research and diagnostics, supporting talent development.
  • 南方医科大学南方医院 (Southern Hospital of Southern Medical University)coreStrategic or Co-development Partner · 1 May 2025Southern Hospital is the lead institution for the National Key R&D Program 'Disease-Specific Exosome Detection Technology Research and Prototype Development.' Hotgen is a sub-project collaborating unit, responsible for developing pancreatic cancer exosome diagnostic reagents and detection platforms in partnership with Southern Hospital, CAMS Cancer Hospital, BUCT, and Peking Union Medical College Hospital.
  • 首都医科大学附属北京安贞医院 (Beijing Anzhen Hospital, Capital Medical University)coreStrategic or Co-development Partner · 1 March 2025Shunyu Medical co-developed SGC001 with Anzhen Hospital. Prof. Du Jie from Anzhen Hospital leads the clinical development. Anzhen is the project lead unit for the 2026 National Science and Technology Major Project for innovative drug R&D, with Shunyu as a major participant. Anzhen Hospital serves as lead PI site for SGC001 Phase II.
  • 北京昭衍生物技术有限公司 (Beijing JOINN Biologics Co., Ltd.)coreStrategic or Co-development Partner · 1 March 2025Shunyu Medical signed strategic cooperation agreement with JOINN Biologics for integrated drug development services. JOINN will provide full-service CMC support from early drug discovery through IND filing, including process development and GMP manufacturing.
  • 北京昭衍新药研究中心股份有限公司 (JOINN Biologics — Staidson)coreImplementation/ SI/ Consulting Partner · 1 March 2025Shunyu Medical signed strategic cooperation with JOINN Staidson for nonclinical CRO services including pharmacology, pharmacokinetics, and toxicology studies to support IND applications.
  • 首都医科大学附属北京佑安医院 (Beijing Youan Hospital, Capital Medical University)coreStrategic or Co-development Partner · 3 January 2025Hotgen signed a technology transfer agreement with Youan Hospital for the 'MAFLD key gene polymorphism joint detection reagent kit' developed by Prof. Zhang Jing's team. Youan is also collaborating on a serum CK18 diagnostic study for MASH. Hotgen donated RMB 1M to Youan's disaster relief fund.
  • 中国食品药品检定研究院 (NIFDC, National Institutes for Food and Drug Control)coreStrategic or Co-development Partner · 1 January 2025NIFDC serves as the regulatory validation authority for Hotgen's diagnostic products and is a collaborating unit in the National Key R&D Program for disease-specific exosome detection. C-GALAD model products have passed NIFDC registration validation.
  • 中国医学科学院北京协和医院 (Peking Union Medical College Hospital, CAMS)coreStrategic or Co-development Partner · 1 January 2025Peking Union Medical College Hospital collaborated with Hotgen on the National Key R&D Program for disease-specific exosome detection. Hospital hosted international medical expert delegations visiting Hotgen for academic exchange on innovative IVD technologies.
  • 中国医学科学院肿瘤医院 (CAMS Cancer Hospital)coreStrategic or Co-development Partner · 1 January 2025CAMS Cancer Hospital is a collaborating unit in the National Key R&D Program for disease-specific exosome detection, working with Hotgen on pancreatic cancer exosome diagnostic development.
  • 北京化工大学 (Beijing University of Chemical Technology, BUCT)minorStrategic or Co-development Partner · 1 January 2025BUCT is a collaborating unit in the National Key R&D Program for disease-specific exosome detection, contributing to technology development with Hotgen.
  • 首都医科大学宣武医院 (Xuanwu Hospital, Capital Medical University)coreStrategic or Co-development Partner · 1 January 2025Xuanwu Hospital serves as the lead PI site for AA001 (anti-AD antibody, Hotgen invested company Zhiyuan Bio) Phase Ib clinical trial, with Prof. Tang Yi and Prof. Wei Cuibai as lead investigators.
  • 深圳智源生物医药有限公司 (Shenzhen Zhiyuan Biomedical Co., Ltd.)coreStrategic or Co-development Partner · 1 October 2023Hotgen co-founded the '国人脑健康工程' (National Brain Health Project) joint laboratory with Zhiyuan Bio, focusing on AD and Parkinson's disease diagnostics and treatment. Hotgen invested RMB 40M in Zhiyuan in 2023 to strengthen its AD diagnostic business. Zhiyuan's subsidiary is developing AA001 anti-AD antibody (Phase Ib ongoing) and other neurodegenerative disease drugs.

Scale indicators9 records

Recent moves8 records

Expansion highlights7 records

Hotgen competitors and assessment

Company assessment

Direct peers

  • Snibe (Shenzhen New Industries Biomedical Engineering): Shenzhen-headquartered Chinese IVD company competing head-to-head with Hotgen in chemiluminescence immunoassay platforms (MAGLUMI series) for clinical diagnostics including hepatitis, tumor markers, and infectious diseases. Closest direct competitor by technology stack (CLIA), product menu breadth, and target customer base (tier-2/3 hospitals in China and international markets).
  • Autobio Diagnostics: Zhengzhou-based Chinese IVD major with a comprehensive immunoassay, microbiology, and clinical chemistry menu. Competes with Hotgen in chemiluminescence platforms (Aurora series) and broad immunodiagnostics for hospital laboratories, with overlapping focus areas in hepatitis and tumor markers.
  • Da An Gene (Kinghawk Medical): Sun Yat-sen University-affiliated Chinese molecular diagnostics company specializing in PCR-based infectious disease testing, HPV screening, and nucleic acid diagnostics. Comparable to Hotgen in molecular diagnostics focus areas and hospital sales channels, with stronger positioning in infectious disease molecular testing.
  • BGI Genomics: Shenzhen-headquartered genomics and diagnostics player with capabilities spanning NIPT, oncology liquid biopsy, and infectious disease molecular diagnostics. Comparable to Hotgen in oncology diagnostics/liquid biopsy ambitions and global footprint, though with materially larger scale and a different platform mix (sequencing-led vs. immunoassay).
  • Wanfu Bio (Guangzhou Wondfo): Guangdong-based Chinese IVD player focused on POCT, immunofluorescence, and chemiluminescence platforms. Comparable to Hotgen in POCT competitive dynamics and rapid testing technology, especially for infectious disease and cardiac markers, and a direct competitor in lower-tier hospital channels.

Broad incumbents

  • Mindray Bio-Medical Electronics: China's largest medical device and IVD group with a vastly broader portfolio including patient monitoring, in-vitro diagnostics, and medical imaging. Through its CL-series chemiluminescence analyzers (CL-6000/8000) and reagents, Mindray competes with Hotgen in hospital IVD purchasing decisions, but operates at much larger scale with diversified revenue streams beyond diagnostics.
  • Roche Diagnostics: Global IVD leader with Elecsys/Cobas chemiluminescence platforms and broad hepatitis/tumor marker menus comparable to Hotgen's C-series. Represents the global benchmark competition for liver disease diagnostics and immunodiagnostics in international markets where Hotgen targets expansion via its 600+ certifications.
  • Abbott Diagnostics: Global IVD leader with Architect/i-STAT/Alinity immunoassay and point-of-care platforms overlapping Hotgen's CLIA and UPT POCT offerings. Comparable in hepatitis serology and cardiac marker menus, and a major competitor for international expansion opportunities in emerging markets.

Emerging players

  • KingMed Diagnostics: China's largest independent clinical laboratory service provider that operates as a customer and partial competitor to IVD manufacturers like Hotgen. Comparable in serving the diagnostic testing needs of Chinese hospitals, with material overlap in liver disease, infectious disease, and oncology testing demand drivers.

Others

  • Innovent Biologics: Leading Chinese innovative drug developer with FDA-approved biologics and a deep oncology pipeline. Comparable to Hotgen's Shunjing Biomedical subsidiary for the innovative drug pipeline dimension — both are Chinese biotechs pursuing first-in-class antibody therapeutics with global regulatory ambitions (NMPA + FDA). Innovent serves as a benchmark for valuation of innovative Chinese biologics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Hotgen social profiles

Digital presence

Hotgen financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Hotgen leadership team

Management profile

Number of profiles

Profiles11 records

Hotgen subsidiaries and ownership

Company hierarchy

Subsidiaries8 records

Hotgen funding detail

Funding detail

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Hotgen M&A and investment

M&A and investment

M&A

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Hotgen

What does Hotgen do?

Hotgen develops, manufactures, and sells in vitro diagnostic (IVD) instruments and reagent kits built on four integrated technology platforms: Magnetic Microparticle Chemiluminescence Immunoassay (CLIA), Up-Converting Phosphor Technology (UPT) for point-of-care testing, GlyExo-Capture® sugar-chain exosome capture, and multi-omics DNA methylation/microRNA detection. The company also operates a comprehensive liver disease diagnostic ecosystem (国人肝健康工程) covering hepatitis-to-liver-cancer screening and is developing an innovative drug pipeline through controlled subsidiary Shunjing Biomedical, including first-in-class antibody drug SGC001 for acute myocardial infarction.

Is Hotgen a public or private company?

Hotgen is a public company. It is classified as public and is currently operating.

When was Hotgen founded?

Hotgen was founded in 2005. It employs 1,001 to 5,000 people.

Where is Hotgen based?

Hotgen is headquartered in Daxing, China, in the Asia region.

How does Hotgen make money?

Three revenue lines are on record. IVD Reagent and Instrument Sales (Clinical Diagnostics) is the primary driver. The others are public Safety and Food Safety Testing Products and pharmaceutical Pipeline (Innovative Drugs).

Who are Hotgen's main competitors?

Direct peers on record are Snibe (Shenzhen New Industries Biomedical Engineering), Autobio Diagnostics, Da An Gene (Kinghawk Medical), BGI Genomics and Wanfu Bio (Guangzhou Wondfo). Broad incumbents are Mindray Bio-Medical Electronics, Roche Diagnostics and Abbott Diagnostics. KingMed Diagnostics is listed as an emerging player. Innovent Biologics is listed as an others.

Does Hotgen have an API?

No public API is recorded for Hotgen.

What industry is Hotgen in?

Hotgen's product category is In Vitro Diagnostics (IVD). Its primary akta.pro industry code is HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy), with a secondary code of HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD). Its NAICS code is 325413 and its SIC code is 2835.

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Live signals
NewswiseHotgen to Present Innovative Immunodiagnostic Solutions at ADLM 2026Beijing Hotgen Biotech Co., Ltd. will participate in ADLM 2026 to showcase its innovative immunodiagnostic solutions, including the flagship MQ60 Series and various chemiluminescence systems. The company highlights its proprietary technology platforms and global reach, with products currently available in over 50 countries.PR Newswire2026 China FIC Innovation and Collaboration Summit Held in San Francisco, Chinese Pharmaceutical Companies Showcase Innovative AchievementsThe 2026 China FIC Innovation and Collaboration Summit was held in San Francisco during the J.P. Morgan Healthcare Conference, organized by the ZFIC Alliance, where leading Chinese pharmaceutical companies showcased cutting-edge technology platforms and R&D pipelines to the global biopharmaceutical industry. Youngen Biotech presented its Kardia Shuttle™ cardiac-targeted delivery platform highlighting China's entry into the global front ranks of RNAi drug innovation, while Sungen Biomed unveiled its SG Linker-Payload ADC technology platform and announced that SGC001, the world's first antibody drug for myocardial infarction, has entered Phase II clinical trials, with another oncology candidate SGT003 planned for simultaneous IND filings in China and the United States in 2026. Hotgen Biotech, which holds a majority stake in Sungen Biomed and a minority stake in Youngen Biotech, reaffirmed its commitment to original innovative drug development as Chinese biopharmaceutical companies intensify their participation in global pharmaceutical innovation competition.PR NewswireSungen Biomedical's world-first new drug SGC001 monoclonal antibody receives FDA fast track approvalOn March 17, 2025, the world's first acute myocardial infarction (AMI) antibody drug, SGC001, developed by Sungen Biomedical (incubated by Beijing Hotgen Biotech Co., Ltd.), received Fast Track Designation from the FDA. The drug has completed healthy individual clinical trials demonstrating a favorable safety profile, and the Fast Track status is expected to shorten its commercialization timeline by enabling rolling reviews, priority review, and accelerated approval pathways. This designation, awarded for treatments targeting serious conditions with unmet medical needs, allows closer FDA interaction throughout the development process.