Dark Horse Consulting Group, a leading strategic and operational consulting enterprise in the field of biological therapy (hereinafter referred to as " DHCG" or "Group") and KunTuo Medical Research and Development (Beijing) Co., a full-service contract research organization committed to providing clinical research services in China , Ltd. (hereinafter referred to as "KunTuo") today announced the signing of a memorandum of understanding (MOU) to formally reach strategic cooperation. The two sides aim to provide a comprehensive and integrated path for research and development enterprises in the field of biological therapeutic drugs to carry out clinical trials in China.

This cooperation combines DHCG's all-round consulting capabilities in the fields of regulatory affairs, CMC, non-clinical, clinical, quality and compliance, supply chain, commercial listing and business analysis with KunTuo's profound clinical research expertise and rich clinical resources throughout China. KunTuo is a contract research organization (CRO) established by IQVIA for the Chinese market, adhering to IQVIA's excellent quality management system. Since its establishment in 2011, it has provided more than 1,000 clinical research services for pharmaceutical and medical device enterprises at home and abroad. The two institutions will work together to provide customers with an integrated service path from global regulatory strategies to local clinical implementation.

China is one of the fastest growing and most strategic markets in the field of advanced therapy. For customers who intend to carry out clinical trials in this market, this cooperation aims to solve a long-standing problem: how to break through the barriers between international regulatory strategies and local clinical operations. To this end, KunTuo has set up a professional clinical team of cell and gene therapy to provide rich experience in the development and management of complex clinical projects in China's top research institutions; while DHCG has rich professional knowledge and is well aware of the regulatory requirements of clinical trials in China, FDA and other supervision. The expectations of institutions when evaluating the data generated in China's clinical environment, and the clinical design considerations required to ensure that the experimental data can be effectively used in future regulatory declarations.

By integrating these capabilities under the framework of formal cooperation, DHCG and KunTuo will help bidders and researchers advance their projects at a faster speed, greater confidence and higher efficiency, so as to reduce the friction between global regulatory strategies and local clinical implementation and avoid the results of these frictions. Start-up delay.

Dr. Anthony Davies, founder and CEO of Dark Horse Consulting Group, said: "This memorandum of understanding signed with KunTuo marks our cooperation for customers who want to promote projects in China. Partners have taken another important step in providing integrated solutions. By combining KunTuo's rich experience in cell and gene therapy clinical trials with DHCG's deep accumulation in the field of global strategic consulting, we can provide truly differentiated services for R&D enterprises at all stages of R&D.

Linda Wang, general manager of KunTuo, said, "Cell and gene therapy is one of the most promising frontiers in the field of biomedicine. We are honored to cooperate with a consulting institution of such a level as DHCG. Since 2018, KunTuo has been committed to building a clinical team focusing on cell and gene therapy-related products, and is in a leading position in this field in China. By working with Dark Horse Consulting Group, we can integrate the professional capabilities of both sides to provide global developers with one-stop solutions covering global regulatory strategies, drug development and clinical trial execution, and help innovative therapies benefit faster and more efficiently. and patients."

This cooperation will take effect from now on. The two sides are expected to launch a joint customer project in the near future.