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Company Overview


BioDlink, a controlled subsidiary of WuXi XDC, is a leading global CDMO specializing in biologics and bioconjugates (ADCs/XDCs). Headquartered in Suzhou with centers in Shanghai and Beijing, the company provides fully integrated, end-to-end services spanning early R&D through commercial manufacturing.   


With its one-base integrated platform and proprietary technologies—such as BDKcell® for rapid cell line development and GL-DisacLink® for site-specific conjugation—BioDlink helps partners accelerate development, improve efficiency, and reduce costs.   The company operates four commercial manufacturing lines with large-scale sterile fill-finish capabilities, backed by a global GMP-aligned quality system that has earned PMDA accreditation in Japan and supported product approvals across China, Indonesia, Nigeria, Pakistan, Colombia and Bolivian.   


Guided by the philosophy of “Quality First, Innovation Driven, Success Together,” BioDlink is committed to advancing global access to next-generation biologics and building trusted partnerships worldwide.


Corporate Culture

Vision
Empowering pharmaceutical innovation to improve the quality of life and safeguard human health
Mission
To be the industry-leading and customer-trusted best partner in biopharmaceuticals
Strive for Better Life
Values

Manufacturing Base

Headquartered in Suzhou Industrial Park, BioDlink provides end-to-end CDMO services to the customers leveraging established technology platforms and production capabilities.

BioDlink possesses a “one-site ∙ end-to-end” commercial manufacturing platform integrating the manufacturing of monoclonal antibody and ADC, which can fulfill the manufacturing capacity demands of different scales including lab-, pilot- and commercial scales.

  • Building 1

    ADC manufacturing base:

    ADC drug substance production lines

    ADC drug product production line


    Small molecule oral drug production base
  • Building 3

    Global R&D Center

    Innovative technology development

    Process development

    Quality control

    Administration center

  • Building 2

    ADC manufacturing base:

    ADC drug substance production lines

    ADC drug product production lines (lyophilized formulate/injectable solution)


    Antibody drugs manufacturing base (DS > 20,000 L; drug product preparation):

    Antibody drug substance production lines (equipped with 200 L, 500 L and 2,000 L bioreactors)

    Production lines for mAb drug products (lyophilized formulate/injectable solution)

  • Building 4 (planning)

    Biopharmaceutical production base
  • Building 5 (planning)

    Biopharmaceutical production base

MAH

BioDlink has successfully developed a diverse range of high-quality anti-tumor drugs across multiple series and varieties, owing to its outstanding research and development and production capabilities. Additionally, BioDlink actively engages in diversified strategic collaborations with domestic and foreign pharmaceutical companies to further enhance its R&D and production capabilities, as well as to expand its product portfolio and market competitiveness.

Drug Development to Commercialization

BioDlink has established an integrated platform with independent analytical capabilities, spanning across the stages of R&D, clinical development, GMP manufacturing, and commercial production. BioDlink provides efficient services as a one-stop CDMO from drug development to successful commercialization.

Milestones

2010
BioDlink was established with its headquarter located in Suzhou Industrial Park, covering an area of approximately 50,000 ㎡
2012

Completed the construction of a manufacturing base spanning 10,000 ㎡

2016

Awarded as the third MAH cooperation pilot unit in China and the first in Jiangsu Province

2017
The pilot-scale biomanufacturing workshop has successfully passed the IND registration inspection
2018
The 13,000 square meter commercial-scale biopharmaceutical production facility has been constructed and activated
2019
BioDlink was listed on the Hong Kong Stock Exchange in November (1875.HK)
2020

The ADC commercial production workshop has been constructed and activated

2021
Pusintin®, Tazian®, and Megaxia® has received marketing approval from NMPA, and have established territory-based commercialization collaborations
2022

Commercial manufacturing base for antibody and ADC Passed GMP Compliance Audit by EU QP

2023

Global R&D Service Center is in operation

New ADC commercial DS and DP production line is active

New antibody commercial DS and DP (lyophilized) production line is active

2024
Overseas GMP certifications, including from Egypt, Indonesia, Colombia, and Pakistan.The foreign manufacturer qualification for antibodies/ADC from PMDA (JP).
New intelligent lyophilized filling line inaugurated.ADC R&D platform technology services and cell line development platform launched

Code of Business Ethics

BioDlink believes that compliance with the laws and regulations and adherence to business ethics is the obligation and responsibility of any enterprise to the public and its shareholders.

If you have any issues to report, please send an email to: jubao@biodlink.com.