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Dark Horse Consulting Group and IQVIA-Founded KunTuo Sign MOU to Accelerate Cell and Gene Therapy Trials in China

COMPANY PROFILE
  • Dark Horse Consulting Group (DHCG), a global biotherapeutics consulting firm, and KunTuo Medical Research and Development (Beijing) Co., Ltd., a full-service CRO established in China by IQVIA, have signed a Memorandum of Understanding to create an integrated pathway for cell and gene therapy sponsors seeking to conduct clinical trials in China.
  • The collaboration combines DHCG’s global regulatory, CMC, nonclinical, clinical, quality, supply chain, and commercial launch consulting capabilities with KunTuo’s dedicated cell and gene therapy clinical team, network of over 10,000 department enrollment data points, and nearly 500 institution and department process records across China.

Dark Horse Consulting Group (“DHCG”), a leader in strategic and operational biotherapeutics consulting, and KunTuo Medical Research and Development (Beijing) Co., Ltd. (“KunTuo”), a full-service CRO dedicated to clinical research services in China, announced the signing of a Memorandum of Understanding (MOU) on May 11, 2026, to establish a strategic collaboration aimed at providing biotherapeutics developers with a comprehensive, integrated path to conducting clinical trials in China.

The partnership unites DHCG’s consulting capabilities across regulatory, CMC, nonclinical, clinical, quality and compliance, supply chain, commercial launch, and business analytics with KunTuo’s deep clinical research expertise and clinical resources across China. KunTuo, established by IQVIA as a dedicated CRO for the Chinese market, operates with IQVIA’s quality management system and has delivered more than 1,000 clinical research services for pharmaceutical and medical device companies in China and abroad since its founding in 2011. The collaboration is effective immediately, with joint client engagements expected to commence in the near term. 

For cell and gene therapy sponsors targeting the Chinese market, the partnership directly addresses the operational complexity of aligning international regulatory strategy with local clinical execution. KunTuo brings a dedicated cell and gene therapy clinical team with experience developing and managing complex clinical programs across leading Chinese research institutions, while DHCG contributes expertise in the regulatory requirements governing trials in China, FDA expectations for data generated in Chinese clinical settings, and the clinical design considerations necessary to ensure trial data can be effectively leveraged in future regulatory submissions. 

DHCG was founded in 2014 with the purpose of accelerating development and delivery of cell and gene therapies. The Group now comprises three business units — DHC, BioTechLogic, and Converge Consulting — with Bruder Consulting & Venture Group forming a specialized Regenerative Medicine department and CJP joining as a Dark Horse Consulting company, both as of early 2026. KunTuo, as a wholly owned subsidiary of IQVIA operating with a team of nearly 1,000 employees, has accumulated clinical resources spanning more than 10,000 department enrollment data points and process information from nearly 500 institutions and departments across China. 

“This MOU with KunTuo represents another meaningful expansion of the integrated solutions we can offer our client partners who are looking to advance their programs in China. KunTuo’s experience in cell and gene therapy clinical trials, combined with DHCG’s global strategic consulting depth, creates a genuinely differentiated offering for developers at every stage of the development journey.”

Anthony Davies, Ph.D., Founder and CEO, Dark Horse Consulting Group

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