Topgene

What Topgene does

Topgene (湖北天勤生物科技集团股份有限公司) is a privately-held, Wuhan-headquartered preclinical contract research organization (CRO) founded in 2009, specializing in GLP-compliant drug safety evaluation and efficacy studies anchored on non-human primate (NHP) disease models. The company is organized as a group with wholly-owned operating subsidiaries: Tianqixinsheng (天勤鑫圣) executes GLP safety evaluation, toxicokinetics, and bioanalysis across rodent, dog, and primate species; Tianqiyanjiuyuan (天勤研究院) focuses on NHP and rodent disease model R&D and pharmacology; Tianqixinchen (天勤鑫宸) provides medical device CRO and physician training; and an internal NHP breeding center supplies cynomolgus and rhesus monkeys. Services span nonclinical safety evaluation, pharmacokinetics, pharmacology/efficacy, bioanalysis, molecular imaging (PET-CT/MRI), and medical device testing, with 9 NMPA GLP certifications, OECD GLP (2025), AAALAC International, and CNAS accreditations supporting submissions to NMPA, FDA, and OECD/TGA.

The company generates revenue primarily through fee-for-service preclinical CRO contracts with domestic and international pharmaceutical, biotech, and CGT sponsors (e.g., Hengrui Medicine, Sinopharm, Zhifei Biological, Humanwell, Joincare, and others), with project-based pricing quoted per study. To date Topgene has completed 3,000+ studies, supported 300+ new drug approval applications, and facilitated ~200 new drug projects reaching clinical or market stage including first-in-class and first-domestically-approved programs (mRNA-encoded botulinum toxin FDA IND, IL-17A mAb, etc.). Distinctive technology platforms include the proprietary "Non-human Primate Nervous System Disease Behavior Atlas Construction and Decoding Model" (a 2025 Wuhan City Excellent Vertical Model), a BCI NHP evaluation platform (jointly with Tongji Hospital), and large-animal PET-CT/MRI imaging. Recent strategic priorities center on AI-augmented nonclinical research (joint AI R&D center with Jiangxia Laboratory), brain-computer interface preclinical validation, ecosystem partnerships under Wuchuangyuan, and OECD GLP-enabled international expansion.

Name

Topgene

Legal name

湖北天勤生物科技集团股份有限公司

Website

https://topgenebio.com

Company type

Private

Founded year

2009

Operating status

Operating

Short description

Topgene is a Wuhan-headquartered preclinical CRO founded in 2009, specializing in GLP-compliant non-human primate disease models and large-animal safety evaluation services for pharmaceutical, biotech, and cell/gene therapy clients across China, the U.S., and OECD markets.

Ownership category

akta.pro rank

Product category

Preclinical Contract Research Organization (CRO)

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

In Vivo Pharmacology (Efficacy/PD Models) (HLAGAFAA), Nonclinical Study Management & Regulatory Writing (IND-enabling) (HLAGAFAN), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Preclinical CRO services
• Non-clinical safety evaluation
• Non-human primate models
• GLP toxicology research
• Pharmacokinetics evaluation

Headquarters

HQ city

Wuhan

HQ country

China

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

1. Preclinical Contract Research Services (CRO): Topgene generates revenue by providing fee-for-service preclinical research and evaluation services to pharmaceutical companies, biotech firms, and research institutions. Services are project-based, typically contracted for specific studies (e.g., toxicology, pharmacokinetics, efficacy studies), with pricing based on study scope, animal species, and regulatory requirements. The company has served hundreds of clients and supported over 300 new drug approval applications.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Topgene is a high-tech CRO providing one-stop preclinical drug research and evaluation services to pharmaceutical companies, biotech firms, and research institutions. Its core offerings span GLP-compliant non-clinical safety evaluation, pharmacokinetics, pharmacology/efficacy evaluation, bioanalysis, molecular imaging (PET-CT/MRI), and medical device testing, with a specialization in non-human primate (NHP) disease models and large animal studies for biologics, ADCs, cell and gene therapies, and CNS drugs. Services are delivered across multiple subsidiaries (Tianqin Xinsheng, Tianqin Research Institute, Tianqin Xinchen) and supported by 9 NMPA GLP certifications plus OECD GLP, AAALAC, and CNAS accreditation.

Product overview

Topgene (湖北天勤生物科技集团股份有限公司) is a CRO company providing preclinical drug research and evaluation services, established in 2009 and headquartered in Wuhan. The company operates a platform-based model consisting of six core services: Non-clinical Safety Evaluation (GLP compliant), Pharmacokinetics Evaluation, Pharmacology/Efficacy Evaluation, Bioanalysis, Molecular Imaging, and Medical Device Testing. These services are delivered through subsidiaries including Tianqin Xinsheng (GLP safety evaluation with 9 NMPA GLP certifications and OECD GLP certification), Tianqin Research Institute (disease model development and efficacy evaluation), and Tianqin Xinchen (medical device testing and physician training). The company specializes in non-human primate models and large animal testing, supporting drug development from early research through IND submission.

Differentiator

Problem solved

Functional benefit

Brands

• 天勤鑫圣 (Tianqixinsheng): Wholly-owned subsidiary providing GLP-compliant preclinical drug safety evaluation, toxicology, pharmacokinetics, and biological analysis services. Holds NMPA, FDA, and OECD GLP certifications.
• 天勤研究院 (Tianqiyanjiuyuan)
• 天勤鑫宸 (Tianqixinchen)
• 武汉市非人灵长类实验动物繁育与疾病模型产业创新中心 (Wuhan NHP Breeding & Disease Model Industry Innovation Center)

Products and services

• Non-clinical Safety Evaluation (非临床安全性评价) GLP-compliant drug safety evaluation services covering single and repeated dose toxicity testing (rodent and non-rodent), reproductive toxicity (Segments I, II, III), genotoxicity (Ames, micronucleus, chromosome aberration), carcinogenicity, local toxicity, immunogenicity, safety pharmacology, and toxicokinetics. Supports NMPA, FDA, and OECD GLP submissions.
• Pharmacokinetics Evaluation (药代动力学评价) PK/PD studies using LC-MS/MS, ELISA, MSD, qPCR, and flow cytometry platforms for drug metabolism, tissue distribution, and drug interaction assessments in support of preclinical drug development.
• Pharmacology / Efficacy Evaluation (药理药效评价) Disease model development and drug efficacy evaluation services covering neurological, hepatic, metabolic, cardiovascular, urological diseases and oncology using various animal species including non-human primates.
• Bioanalysis (生物分析) Bioanalytical services for biomolecules including antibodies, nucleic acids, and peptides using LC-MS/MS, ELISA, MSD, qPCR, and flow cytometry platforms.
• Molecular Imaging (分子影像检测与分析) PET-CT and MRI imaging services for large animals providing pharmacokinetic parameters, disease model diagnosis, treatment monitoring, and drug targeting evaluation.
• Medical Device Testing (医疗器械测试) Preclinical animal studies for medical devices including feasibility, safety and efficacy research, physician skills training, and surgical robot procedure development.
• Non-human Primate Breeding Center (非人灵长类繁育中心) Breeding and supply of non-human primates (cynomolgus monkeys, rhesus monkeys) for research purposes, providing experimental animal supply for drug research and evaluation services.

Quantifiable outcome

• Over 3,000 completed specialized research studies and 300+ new drug declaration varieties supported
• +4 more outcomes

Named customers29 records

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability5 records

Feature4 records

Partnerships

15 partnerships are on record, tiered core, moderate and minor.

• 湖北江夏实验室 (Hubei Jiangxia Laboratory)coreStrategic or Co-development Partner · 1 October 2025Joint establishment of 'AI Nonclinical Drug R&D Center' at Donghu Forum, focusing on AI-powered in vitro toxicity models, organoid/organ-on-chip platforms, and virtual animal experiment exploration to develop alternative research tools aligned with 3R principles.
• 睿智医药科技股份有限公司 (Shanghai Wisege Bio/JiZhi Pharma)coreStrategic or Co-development Partner · 1 July 2025Strategic agreement to build a comprehensive 'target-to-IND' one-stop new drug R&D platform integrating Wisege Bio's early-stage discovery capabilities with Topgene's preclinical safety evaluation expertise in biologics, CGT, and NHP models.
• 同济医院综合类国家医学中心科创院 (Tongji Hospital National Medical Center Innovation Institute)moderateStrategic or Co-development Partner · 1 June 2025Topgene participates in the establishment of the Tongji Hospital National Medical Center Science and Innovation Institute Council, integrating Tongji's R&D and talent resources with Topgene's NHP models, nonclinical research services, and large animal molecular imaging platforms.
• 武汉友芝友生物制药股份有限公司 & 鼎康(武汉)生物医药有限公司 (Wuhan Youzhiyou Biopharma & Dingkang Biologics)coreStrategic or Co-development Partner · 1 April 2025Trilateral strategic cooperation under Wuhan Industrial Innovation Development Research Institute to build a full-chain innovative drug R&D ecosystem combining Youzhiyou's bispecific antibodies, Topgene's nonclinical evaluation, and Dingkang's CDMO manufacturing capabilities for global regulatory standards.
• 江苏耀海生物制药有限公司 (Jiangsu Yaohai Biologics)moderateStrategic or Co-development Partner · 1 March 2025Strategic partnership leveraging Yaohai's microbial expression system capabilities (recombinant proteins, nucleic acid drugs, nanobodies) combined with Topgene's GLP preclinical services to build an efficient R&D service system for biopharmaceutical clients.
• 深圳迈瑞动物医疗科技股份有限公司 & 武汉和兴康科技有限公司 (Mindray Animal Medical & Wuhan Hexingkang)moderateStrategic or Co-development Partner · 1 August 2024Trilateral cooperation focusing on efficacy and safety evaluation of animal medical equipment, accumulating animal medical data, improving existing devices, and solving human-use equipment challenges in veterinary settings.
• 中国科学院武汉植物园 (Chinese Academy of Sciences Wuhan Botanical Garden)moderateStrategic or Co-development Partner · 1 July 2024Strategic cooperation to leverage CAS Wuhan Botanical Garden's expertise in medicinal plant resources and bioactive compound screening, combined with Topgene's preclinical evaluation capabilities, for cardiovascular drug R&D, platform co-development, and talent cultivation.
• 武汉产业创新发展研究院 (Wuhan Industrial Innovation Development Research Institute, Wuchuangyuan)coreStrategic or Co-development Partner · 1 May 2024Topgene serves as the Innovation Drug Discovery and Nonclinical Evaluation Service Platform under Wuchuangyuan, integrating into the broader Wuhan bioindustry innovation ecosystem and receiving institutional support for AI-driven nonclinical research center development.
• 沃特世 (Waters Corporation)moderateTechnology or Integration · 1 April 2024Joint laboratory establishment between Tianqin Xinsheng and Waters to solve analytical challenges in chromatography and mass spectrometry for bioanalysis in drug research, elevating quality standards of compliant bioanalytical laboratories.
• 武汉市发展和改革委员会 (Wuhan Municipal Development and Reform Commission)coreOthers · 1 December 2023Topgene's 'Wuhan Non-human Primate Experimental Animal Breeding and Disease Model Industry Innovation Center' was officially approved and established as one of 6 city-level industry innovation centers, focusing on NHP breeding standards and disease model development.
• 武汉轻工大学 (Wuhan Polytechnic University)minorOthers · 1 December 2023Joint establishment of a graduate student workstation to provide students with research practice opportunities, promote industry-academia-research integration, and support talent development for the biotech sector.
• 上海吉凯基因医学科技股份有限公司 (Shanghai Jigene)moderateStrategic or Co-development Partner · 1 November 2023Strategic cooperation covering integrated drug toxicology safety evaluation, clinical research translation, and resource coordination to provide comprehensive services to pharma clients.
• 中国地质大学(武汉) (China University of Geosciences, Wuhan)coreStrategic or Co-development Partner · 1 August 2023Joint R&D of the 'Non-human Primate Nervous System Disease Behavior Atlas Construction and Decoding Model' since 2022, combining Topgene's NHP model expertise with CUG's data science capabilities. The model was selected as a 2025 Wuhan City Excellent Vertical Model.
• 武汉滨会生物科技股份有限公司 (Wuhan Binhui Bio)moderateStrategic or Co-development Partner · 1 June 2023Comprehensive strategic partnership in new drug R&D services, technology innovation, and AI platforms, aiming to build a Wuhan-scale integrated new drug discovery, screening, safety evaluation, CMC development, and clinical trial service system.
• 华中科技大学同济医学院附属同济医院 (Tongji Hospital, Tongji Medical College, HUST)coreStrategic or Co-development PartnerTopgene is a key partner in the first provincial-level brain-computer interface technology innovation platform led by Tongji Hospital with 12 collaborating institutions. Topgene provides nonclinical validation from animal experiments to human clinical translation, particularly leveraging NHP disease models and its proprietary behavioral atlas model.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medicilon: Medicilon (美迪西) is a China-based preclinical CRO with strong capabilities in non-clinical safety evaluation, pharmacokinetics, and pharmacology studies. Competes directly with Topgene for IND-enabling preclinical packages from Chinese innovative-drug developers.
• JOINN Laboratories: JOINN Laboratories (昭衍新药) is the most directly comparable Chinese preclinical CRO, also specializing in GLP-compliant non-clinical safety evaluation with NHP models and similar regulatory certification footprint. Both serve overlapping Chinese innovative-drug customers and compete for IND-enabling safety packages.
• Frontage Laboratories: Frontage Laboratories (方达医药) operates integrated preclinical and clinical CRO services across the US and China, including bioanalysis, DMPK, and safety assessment comparable to Topgene's service portfolio, with similar exposure to Chinese and US biopharma sponsors.
• Sundia MediTech: Sundia MediTech (桑迪亚) is a China-based preclinical CRO offering in vivo pharmacology, PK, and toxicology services with capabilities similar to Topgene's preclinical portfolio. It serves a comparable customer base of Chinese biotech and pharmaceutical innovators.
• Shanghai ChemPartner: ChemPartner is a China-headquartered CRO providing drug discovery and preclinical evaluation services including toxicology, PK, and bioanalysis. It overlaps with Topgene in preclinical safety and pharmacology offerings for Chinese and global biopharma.

Regional players

• Hangzhou Tigermed: Tigermed (泰格医药) is a leading China-headquartered clinical CRO with growing preclinical investments; it does not directly compete for Topgene's NHP toxicology work but serves many of the same Chinese biopharma sponsors on clinical development packages.

Broad incumbents

• Labcorp Drug Development: Labcorp (including the legacy Covance preclinical business) operates global preclinical safety, PK, and bioanalytical services comparable to Topgene's offerings. It targets the same multinational biopharma sponsors with global IND-enabling packages.
• Charles River Laboratories: Charles River is the global leader in preclinical CRO services with extensive NHP toxicology, safety assessment, and bioanalysis capabilities. It competes with Topgene for global biopharma's IND-enabling preclinical work and represents the international gold standard Topgene benchmarks against.
• WuXi AppTec: WuXi AppTec (药明康德) is the largest China-based CRO/CDMO with a preclinical safety evaluation business within its broader discovery-to-manufacturing platform. It competes with Topgene on IND-enabling toxicology but at a vastly greater scale and with global client reach.
• Pharmaron: Pharmaron operates an integrated global CRO/CDMO platform spanning preclinical safety evaluation, DMPK, and bioanalysis with facilities in China, the US, and UK. It competes for global IND-enabling preclinical work, though its toxicology footprint is more modest than Topgene's specialized GLP/NHP focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

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Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries5 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Topgene