With over a decade of deep expertise in the field of fully automated chemiluminescence immunoassay (CLIA), Zecen Biotech Co., Ltd. holds proprietary intellectual property rights and multiple invention patents for its intelligent diagnostic system based on tube‑based magnetic particle chemiluminescence immunoassay.
In 2023, Zecen Biotech Co., Ltd. formally initiated a strategic partnership with Sysmex Corporation of Japan, engaging in a closely integrated "gear‑like" collaboration in the biochemical and immunological IVD reagent space under a CDMO model.
Through this CDMO arrangement, Zecen provides custom R&D and manufacturing outsourcing services to Sysmex. The cornerstone of this collaboration is the service provider's demonstrable, robust technological innovation capability.
This strategic partnership signifies that Zecen Biotech Co., Ltd.'s innovation capacity has gained even greater recognition from a global industry leader. While continuing to develop its own proprietary business, Zecen has added a new "engine" – service outsourcing – and has thus entered a "dual‑engine" development phase.
Beyond its self‑operated business, Zecen Biotech Co., Ltd. has already partnered with multiple well‑known IVD companies both in China and internationally, providing chemiluminescence raw materials, reagent kits, and detection system solutions.
Leveraging its global service network, ISO 13485 quality system, and CE certification compliance, Zecen Biotech Co., Ltd. offers its partners full‑process CDMO services—from core raw materials and biomarker development to customized manufacturing and regulatory consulting—helping partners quickly capture market opportunities.
Core Raw Material Manufacturing
Zecen Biotech Co., Ltd. independently researches, develops, and manufactures core raw materials, including antibodies, magnetic beads, and labeling technologies, covering the entire CLIA industrial chain, with the capacity for global large‑scale supply.
The company has filed multiple invention patents in the preparation of magnetic microparticles and luminescent substrates, and holds independent intellectual property rights in the development of key raw materials. In core reagent technologies such as magnetic bead conjugation, antibody labeling, and substrate synthesis, Zecen Biotech Co., Ltd. possesses comprehensive and leading‑edge capabilities. The company's proprietary fully automated tube‑based chemiluminescence immunoassay analytical system, which combines magnetic particle‑based separation and purification technology with chemiluminescent enzyme immunoassay, extends the linear range of detection, improves detection sensitivity, and accelerates analytical throughput. This technological approach is currently at the forefront of international immunoassay.
With 95% of core raw materials self‑sufficient, and underpinned by a complete CLIA industrial chain layout, the company is well‑positioned to supply high‑quality core raw materials to global partners at scale.
Regulatory Consulting and Auditing
Drawing on its extensive experience in CE certification and its global market presence, Zecen Biotech Co., Ltd. provides regulatory consulting and quality auditing support that meets regional regulatory requirements, helping partners comply with both internal and external standards.
The company has obtained CE certification for over 300 products. In addition, it holds nearly 30 Class III registration certificates, more than 200 Class II registration certificates, and nearly 50 Class I filings. The company strictly adheres to the Medical Device Production Quality Management Practices and ISO 13485:2016 quality management system standards, having established and implemented a quality management system tailored to the characteristics of its products.
In the strategic collaboration with Sysmex, Sysmex has introduced its stringent quality management system into Zecen Biotech Co., Ltd. and provides quality management talent development for Zecen, aiming to enhance product quality through rigorous production specifications and strict quality inspection standards. This in‑depth cooperation has further strengthened Zecen's systematic capabilities in quality management and regulatory compliance.
With extensive experience in domestic and international registration and certification, as well as a multi‑market global presence, Zecen Biotech Co., Ltd. is able to offer partners full‑lifecycle regulatory consulting and quality auditing support—covering product design and development, registration testing, clinical trials, and post‑market compliance.
Chemiluminescent Immunoassay Manufacturer Service
Contract Development（CDMO R&D Services）
Focusing on areas such as thyroid, cancer, and cardiac markers, we provide R&D services for IVD raw materials and novel biomarkers; and offer integrated solutions encompassing raw material supply and biomarker development. Through independent R&D and international collaboration, Zecen Biotech Co., Ltd. continues to develop reagents for multiple novel and specialized projects, including early cancer screening, geriatric diseases, and psychiatric disorders—helping partners save valuable time and R&D costs while building a more attractive assay menu.
OEM Collaboration
OEM production of over 100 existing assay items is available for rapid product launch. The company has obtained CE certification for more than 300 products, providing OEM partners with a broad selection from its rich product pipeline. Zecen Biotech Co., Ltd. has already established OEM partnerships with multiple well‑known IVD companies both domestically and internationally.
ODM Collaboration
Joint design of new reagents or new detection platforms, with customized technical solutions based on self‑developed core raw materials. Leveraging its proprietary core raw materials (magnetic beads, antibodies, labeling technologies, etc.) and its leading chemiluminescence technology platform, Zecen Biotech Co., Ltd. can participate from the ground up in the design and development of new reagents or detection platforms according to partners' specific requirements.
Core Raw Material Supply
Separate supply of core raw materials, including magnetic beads and enzyme‑labeled antibodies, to support partners' production needs. With 95% of core raw materials self‑sufficient, we can independently supply high‑quality magnetic beads, enzyme‑labeled antibodies, and other core raw materials to global partners.
AMH Collaboration
The AMH (Authorized Marketing Holder) model is a regulatory framework in which the marketing authorization for medical devices is separated from the manufacturing authorization. Companies that hold product registration certificates/marketing authorizations may outsource manufacturing to qualified CDMO enterprises, while focusing their own efforts on brand operation and market promotion.
As a CDMO enterprise with full‑chain independent intellectual property rights and large‑scale production capabilities, Zecen Biotech Co., Ltd. can provide AMH partners with comprehensive contract manufacturing services, spanning product design and development, process validation, registration testing, and commercial production. Under this model, partners retain the product registration certificates, while Zecen Biotech Co., Ltd. leverages its 8,000 m² GMP‑compliant manufacturing facility, annual instrument production capacity of 5,000 units, and annual reagent production capacity of 100 million tests to deliver compliant, stable, and high‑quality contract manufacturing services. This enables AMH clients to achieve the strategic goal of "asset‑light operations and brand‑focused development." Zecen Biotech Co., Ltd. itself has obtained multiple product registration certificates, including the Anti‑Müllerian Hormone (AMH) Assay Kit (Magnetic Particle Chemiluminescence Method), giving it substantial hands‑on experience in full‑process AMH management.
SKD (Semi‑Knocked Down) Collaboration
SKD (Semi‑Knocked Down) is a production collaboration model in which products are shipped as semi‑finished goods or major subassemblies, and customers perform final assembly at their own factories in their home countries. Compared with direct export of finished instruments, the SKD model can effectively reduce import tariff costs while helping customers establish local assembly capabilities and develop their own brands.
Leveraging its complete independent R&D and manufacturing capabilities for fully automated chemiluminescence immunoassay analyzers, Zecen Biotech Co., Ltd. offers international partners SKD semi‑knocked down assembly collaboration services for instruments. The company delivers major subassemblies of the fully automated chemiluminescence immunoassay analyzer (including the optical detection system, fluidics system, control system, etc.) as semi‑finished goods, and provides detailed assembly process documentation, quality control standards, and technical training support to assist customers in completing local assembly, commissioning, and factory acceptance testing in their respective countries. Through the SKD collaboration model, partners can significantly reduce product import costs while gradually building local instrument production and after‑sales service capabilities, enabling rapid response to regional markets and deeper market penetration.
Technology Transfer Collaboration (Localized Production Support)
Technology transfer is an in‑depth collaboration model in which the CDMO enterprise fully transfers its mature production processes, quality control systems, and manufacturing technologies to partners, helping them establish independent production capabilities locally. Technology transfer typically encompasses comprehensive support, including personnel training, equipment selection, raw material supply, methodology establishment, and production environment setup.
Leveraging its core advantage of full‑chain self‑sufficiency and control—95% self‑sufficiency in core raw materials and complete intellectual property rights for the tube‑based magnetic particle chemiluminescence immunoassay analytical system—Zecen Biotech Co., Ltd. can provide in‑depth technology transfer services. The technology transfer scope includes:
Core raw material supply: Continuous supply of high‑quality core raw materials, including magnetic beads and enzyme‑labeled antibodies, ensuring a stable and controllable supply of raw materials for partners'local production.
Production process transfer: Full transfer of mature reagent formulations, production process flows, and quality control standards to partners’local production lines.
Personnel training and system establishment: Deployment of professional technical teams to partners'local facilities to provide comprehensive training and guidance covering equipment operation, process control, and quality management system setup.
Regulatory and registration support: Drawing on extensive CE certification experience (300+ CE‑certified products) and multi‑market global presence, we assist partners in product registration and compliant market access in their local markets.
