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COMPANY PROFILE

HkeyBio is a China-based, globally-focused preclinical CRO dedicated exclusively to the fields of autoimmune and allergic diseases. With a track record of supporting over 500 successful IND filings, we have established ourselves as a trusted partner for biotech and pharmaceutical companies navigating the complex journey from drug discovery to clinical trials.

Our mission is to accelerate your drug development by delivering highly predictive, IND-enabling preclinical data. This is powered by our globally leading Non-Human Primate (NHP) model platform and the world's most diverse autoimmune model data matrix.

Our scientific team brings more than two decades of specialized expertise in autoimmune drug development, with members hailing from top-tier international pharmaceutical companies. We operate from strategically located R&D bases in Suzhou Industrial Park and Guangxi, where our in vivo studies are conducted in AAALAC International-accredited facilities, under an ISO 9001 quality system and GLP principles — allowing us to combine profound biological insight with operational excellence.

We are more than a service provider; we are a science-driven extension of your team. We emphasize transparent communication, rigorous data integrity, and an unwavering commitment to protecting your intellectual property—the essential foundation for building lasting partnerships in global innovation.

Group Structure & Operating Entities

HkeyBio operates as a unified group. All entities under the HkeyBio brand share the same actual controller and brand system, respectively undertaking group-level R&D, regional operations, and local delivery, with unified quality standards and service processes across the entire system.

HkeyBio (Suzhou) Biotech Co., Ltd. | Brand-owning entity, group HQ for core R&D and operations.

Services: autoimmune & allergy animal model development, NHP disease models, preclinical pharmacology & efficacy evaluation, one-stop IND support, global project oversight.

Address: Room 205, Tower B, Building 22, Ascendas iHub, 388 Xinping Street, Suzhou Industrial Park.

Tel: +86-512-67485716.

HkeyBio (Shanghai) Biotech Co., Ltd. | East China operations center, affiliated entity under the same actual controller.

Services: East China client engagement, local CRO project delivery, on-site technical support, business development.

Address: Room 605, No. 7, 489 Yunchuan Road, Baoshan District, Shanghai.

Tel: +86-512-67485716.

Nanning HkeyBio Biotech Co., Ltd. | A wholly-owned subsidiary of HkeyBio (Suzhou); "HkeyBio" is a dedicated regional trade name of the HkeyBio brand family.

Services: preclinical CRO for Southwest China, local delivery of NHP model studies, regional client support.

Address: Room A403, Factory Building, No. 3, North Section of Fazhan Avenue, Xixiangtang District, Nanning, Guangxi.

Tel: +86-512-67485716.

FOCUS ON AUTOIMMUNITY

Building a Highly Translatable and Fully Compliant Preclinical Model System

HkeyBio's core offerings are built on a foundation of highly translatable disease models and an internationally compliant quality system. This creates a comprehensive solution suite for autoimmune and allergic disease research. We deliver not just animal models, but the critical capability to generate high-quality data that supports the entire drug development cycle from early discovery to IND filing.

AAALAC accredited facility in Nanning - Wincon TheraCells Biotechnologies

Nanning facility, AAALAC International accredited (Accredited entity: Wincon TheraCells Biotechnologies Co., Ltd., Nanning, China). HkeyBio's NHP studies are conducted at this accredited facility.

AAALAC accredited facility Suzhou Xishan - Xishan Zhongke Laboratory Animal

Suzhou Xishan breeding base, AAALAC International accredited (Accredited entity: Suzhou Xishan Zhongke Laboratory Animal Co., Ltd., Suzhou, China).

Dual-Track Model Platforms

With 50+ Non-Human Primate (NHP) models and 300+ rodent models, we precisely cover over 50 subtypes across six major disease areas (dermatology, rheumatology, gastroenterology, pulmonology, neurology, endocrinology), providing the most suitable tools for target validation, efficacy assessment, and translational research.

Compliant Data Core

All studies are conducted in AAALAC-accredited facilities, in accordance with GLP principles, and adhere to the ISO 9001 quality management system. This ensures the data generated meets the review standards of major global regulators like the U.S. FDA and EMA.

Translational Value Cycle

Our product system ultimately serves “data-driven decision-making”. By integrating model development, efficacy evaluation, biomarker discovery, and IND filing support, we deliver not merely experimental reports, but a critical chain of evidence that de-risks R&D and accelerates clinical translation.

ONE-STOP AUTOIMMUNE PRECLINICAL SERVICES

Our seasoned technical team deeply understands the core pain points in autoimmune drug R&D, providing full-process customized solutions covering the entire chain of “disease model construction → target validation → efficacy evaluation → biomarker detection → IND filing support”.

Backed by dual test base layout and triple international certifications, we achieve:

Customized Models: Develop exclusive NHP/rodent models based on drug targets and mechanisms.

Compliant Data: Ensure data integrity and process standardization under the ISO 9001 quality system to meet global regulatory reviews.

Efficient Filings: Leverage 500+ IND filing experiences to swiftly resolve application challenges.

Integrated Services: Full-process technical support from project initiation to report delivery. Transparent Value: Clear project-based pricing, leveraging China's R&D ecosystem for significant cost optimization.

ADVANTAGES

Triple International Certifications, Compliance Assured

Studies are conducted in AAALAC International-accredited facilities, under our ISO 9001-certified quality system and GLP principles, with experimental operations following FDA guidelines. Traceable, compliant data fully meets the IND filing review requirements of global regulatory authorities.

Full-Cycle Model Portfolio, Wide Coverage

50+ NHP models + 300+ rodent models, covering 50+ subtypes across six disease systems (skin, joint, digestive, etc.), meeting the needs of the entire R&D cycle from target screening to IND filing.

500+ IND Filing Experiences, Efficient Empowerment

Successfully supported over 500 IND filings for autoimmune new drugs, excelling at solving challenges such as model validation and data compliance during filing, significantly improving approval rates and efficiency.

Master’s/PhD-Led Team, Strong Expertise

Core team with over 20 years of autoimmune drug development experience, all project leaders holding master’s/PhD degrees. Most members are from international pharmaceutical companies, providing full-process professional technical support.

COMPANY PROFILE

Group Structure & Operating Entities

FOCUS ON AUTOIMMUNITY

Building a Highly Translatable and Fully Compliant Preclinical Model System

Dual-Track Model Platforms

Compliant Data Core

Translational Value Cycle

ONE-STOP AUTOIMMUNE PRECLINICAL SERVICES

Backed by dual test base layout and triple international certifications, we achieve:

ADVANTAGES

Triple International Certifications, Compliance Assured

Full-Cycle Model Portfolio, Wide Coverage

500+ IND Filing Experiences, Efficient Empowerment

Master’s/PhD-Led Team, Strong Expertise

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