Dark Horse Consulting Group and KunTuo Announce Memorandum of Understanding Providing Cell and Gene Therapy Developers with an Accelerated Path to Clinical Development in China

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

This partnership unites DHCG's comprehensive regulatory, CMC, nonclinical, clinical, quality and compliance, supply chain, commercial launch, and business analytics consulting capabilities with KunTuo's deep clinical research expertise and abundant clinical resources across China. KunTuo, established by IQVIA as a dedicated CRO for the Chinese market, maintains IQVIA's exceptional quality management system and has provided more than 1,000 clinical research services for pharmaceutical and medical device companies in China and abroad since its founding in 2011. Together, the two organizations will offer client companies an integrated pathway from global regulatory strategy through local clinical execution.

For clients seeking to conduct trials in China, one of the most rapidly growing and strategically significant markets for advanced therapies, this collaboration addresses a persistent challenge: navigating the intersection of international regulatory strategy and local clinical operations. To this end, 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 brings deep expertise in the regulatory requirements governing trials in China, the expectations of the FDA and other regulatory authorities when evaluating data generated in Chinese clinical settings, and the clinical design considerations necessary to ensure that trial data can be effectively leveraged in future regulatory submissions.

By combining these capabilities under a formal collaborative framework, DHCG and KunTuo will enable sponsors and investigators to move their programs forward with greater speed, confidence, and efficiency, reducing the friction between global regulatory strategy and local clinical execution that can result in delays in trial initiation.

“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,” said Anthony Davies, Ph.D., Founder and CEO of Dark Horse Consulting Group. “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.”

“Cell and gene therapy represents one of the most promising frontiers in biopharmaceuticals, and we are proud to partner with a consulting organization of DHCG's caliber,” said Linda Wang, General Manager of KunTuo. “KunTuo has been building a dedicated clinical team for cell and gene therapy-related products since 2018, and we have taken the lead in this space in China. By joining forces with Dark Horse Consulting Group, we can combine expertise from both sides to provide developers worldwide with a one-stop solution that spans global regulatory strategy, drug development, and clinical trial execution — enabling innovative therapies to reach patients faster and more efficiently.”

The collaboration is effective immediately, with joint client engagements expected to commence in the near term.

About Dark Horse Consulting Group

Dark Horse Consulting Group, a worldwide consulting organization with offices in North America, Europe, and APAC, was founded in 2014 with the purpose of accelerating development and delivery of cell and gene therapies through unmatched expertise. Since then, The Group's focus has expanded dramatically, with consulting team subject matter expertise now encompassing strategy, operations, Quality, regulatory affairs, manufacturing, modeling, supply chain, commercial launch, and business optimization across the biopharma landscape. DHCG's white-glove client service is grounded in rigorous scientific and technical expertise to support clients from early discovery through commercial launch. The Group comprises three business units: DHC, BioTechLogic, and Converge Consulting, with Bruder Consulting & Venture Group forming a specialized Regenerative Medicine department of DHC as of early 2026 and CJP joining the group as a Dark Horse Consulting company, also in early 2026.

About KunTuo

KunTuo, as a full-service Contract Research Organization (CRO) specially set up in China by IQVIA (a wholly owned subsidiary of IQVIA) and with a team of nearly 1000 employees, is dedicated to provide high-quality and reliable clinical research services for Pharmaceutical and Medical Device & Diagnostic (MDD) enterprises. Since its establishment in 2011, Kuntuo has provided more than 1000 clinical research services for many well-known pharmaceutical and device companies in China and abroad and now has accumulated rich clinical resources, including more than 10,000 departments' enrollment data and nearly 500 institutions'/departments' process information. Kuntuo inherits IQVIA's sound quality management system and quality standards and provides biomedical enterprises with higher quality and more responsive service model from IND to NDA through the application and optimization of IQVIA's global operation experience and expertise.

Contact
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