Dark Horse Consulting and KunTuo Research and Development announced a memorandum of understanding aimed at helping sponsors advance cell and gene therapy trials in China while enabling reuse of resulting data for future regulatory submissions outside China. Dark Horse said the arrangement is built around KunTuo’s trial services expertise and Dark Horse’s global regulatory strategy. The deal targets the operational and regulatory friction that often complicates multinational advanced-therapy development, including how sponsors can structure trial execution so datasets remain usable for different jurisdictions. Dark Horse also described a broader “integrated solutions” model spanning regulatory strategy, development and trial execution. KunTuo, which traces its origins to IQVIA’s trial services business, positions its CRO experience as spanning more than 1,000 drug trials, with most involving advanced therapies. The partnership also references KunTuo’s buildout since 2018 and a prior collaboration with Porton Advance. For biotech developers exploring China as a development site, data portability and downstream regulatory acceptability remain central. This MOU directly addresses those issues by design, rather than after-the-fact regulatory remediation.
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