YHLO

Shenzhen YHLO Biotech Co., Ltd. operates as one of China’s established in-vitro diagnostics (IVD) companies, focusing on chemiluminescence immunoassay (CLIA) technology. The company develops, manufactures, and distributes diagnostic instruments and reagents across autoimmunity, reproductive health, infectious diseases, and diabetes testing applications, with products reaching nearly 100 countries worldwide.

Company Overview

Founded in 2008, YHLO built its business around immunoassay solutions using proprietary chemiluminescence technology. The company established headquarters at YHLO Biopark in Shenzhen’s Longgang District, where it operates R&D, manufacturing, and administrative functions. In May 2021, YHLO completed its initial public offering on the Shanghai Stock Exchange STAR Market (stock code: 688575.SH), joining the ranks of publicly traded Chinese diagnostics companies.

Chairman Hu Kunhui serves as the company’s controlling shareholder with approximately 47% ownership through direct and indirect holdings. The management team includes executives with backgrounds from Mindray Medical and other established medical device companies, bringing experience in instrument development and international market expansion.

YHLO maintains quality management certifications including ISO 9001:2015 and ISO 13485:2016, along with regulatory approvals from Korea’s KGMP and Australia’s TGA. The company operates an international business office in Shenzhen’s Nanshan District to support global distribution activities.

Core Products

iTLA Max Laboratory Automation System

The iTLA Max represents YHLO’s intelligent laboratory automation platform, officially launched in August 2024 after receiving domestic regulatory clearance. The system processes up to 1,200 sample tubes per hour and incorporates intelligent robotic components for automated consumable handling.

The modular design comprises six main units: sample loading, centrifugation, lid opening, rack connection, magnetic levitation track, and sample extraction. Key technical features include 360-degree ring light indicators for operational status monitoring, waterfall-style ergonomic displays, and AI-powered visual recognition for sample tube identification.

The iTLA Max received the 2024 MUSE Design Awards Gold Prize and an iF Design Award, recognizing both functional innovation and aesthetic execution. West China Hospital completed installation in 2024, with the system supporting connections to immunoassay, biochemistry, hematology, and coagulation analyzers.

iFlash Series Chemiluminescence Analyzers

YHLO’s iFlash product line covers throughput requirements from small clinics to large reference laboratories:

All iFlash models use acridinium ester-labeled direct chemiluminescence with magnetic particle separation. The instruments share reagent compatibility, allowing laboratories to standardize testing protocols across different throughput configurations. iModules configurations can achieve up to 1,200 tests per hour through multi-unit integration.

iBC Biochemistry Analyzers

The iBC 900 and iBC 2000 biochemistry analyzers complement YHLO’s immunoassay portfolio. The iBC 900 achieves 1,200 tests per hour with up to 105 reagent positions, supporting integration with iTLA track systems for complete laboratory automation.

Technology & Innovation

YHLO’s technical platform centers on chemiluminescence immunoassay methodology, where the company claims several domestic firsts including China’s first high-speed CLIA system (iFlash 3000 in 2016) and the country’s first autoimmune disease assays on CLIA, LIA, and ELISA platforms.

The iTLA track system uses magnetic levitation technology, eliminating physical contact between sample racks and transport rails. This contactless design reduces maintenance requirements and enables quiet operation without pneumatic systems.

The company’s reagent menu spans over 176 test items across categories including:

• Autoimmunity (anti-CCP, RF, ANA patterns)
• Reproductive health (AMH, Inhibin B, fertility hormones)
• Infectious diseases (hepatitis panel, HIV, TORCH)
• Cardiac markers (troponin I, BNP, CK-MB)
• Thyroid function (TSH, FT3, FT4)
• Tumor markers (AFP, CEA, CA series)

YHLO developed assays for several markers with limited global availability in CLIA format, including Inhibin B, adiponectin, and ZnT8 autoantibodies for diabetes typing.

Market Presence

By mid-2023, YHLO reported cumulative instrument installations exceeding 7,850 units domestically (excluding retired equipment), with 69 laboratory automation track systems deployed. The company’s “specialty entry, routine expansion” commercial strategy prioritizes establishing presence through differentiated autoimmune and reproductive health assays, then expanding to routine testing volumes.

Reference laboratory installations include Peking Union Medical College Hospital, where YHLO supported migration from ELISA to CLIA technology. Beijing Chaoyang Hospital operates two iTLA track lines, and Beijing Friendship Hospital represents an additional metropolitan installation.

International distribution reaches approximately 100 countries through partnerships with regional distributors. The company maintains research collaborations with institutions in Europe, the United States, Japan, and Australia for assay development and clinical validation.

Key Milestones

• 2008: Company founded in Shenzhen
• 2016: iFlash 3000 launched as China’s first high-speed CLIA system
• 2019: iTLA laboratory automation system first exhibited at CMEF
• 2021: IPO on Shanghai Stock Exchange STAR Market
• 2023: Achieved JCTLM stakeholder membership; passed IFCC-RELA evaluation
• 2024: iTLA Max received NMPA clearance and MUSE Design Gold Award
• 2025: Global launch of iTLA Max at MEDLAB Middle East Dubai

Frequently Asked Questions

Is YHLO a publicly traded company?

Yes, YHLO has been listed on the Shanghai Stock Exchange STAR Market since May 2021 under stock code 688575.SH. The company operates as Shenzhen YHLO Biotech Co., Ltd.

What is the difference between iTLA and iTLA Max?

The iTLA Max represents YHLO’s newer-generation laboratory automation platform launched in 2024, featuring enhanced throughput (1,200 samples/hour), AI visual recognition, and intelligent robotic components for consumable handling. The original iTLA system established the magnetic levitation track technology foundation.

What testing areas does YHLO specialize in?

YHLO maintains particular strength in autoimmune disease testing, reproductive health assays (including AMH and Inhibin B), and infectious disease panels. The company offers over 176 test items across autoimmunity, fertility, diabetes, cardiac markers, thyroid function, and tumor markers.