- ProBio and Kun Tuo, an IQVIA company, have formed a strategic collaboration to support Investigator-Initiated Trials (IITs) and clinical operations for global biopharmaceutical companies developing therapies in China.
- The partnership combines ProBio’s biologics and cell and gene therapy CDMO capabilities with Kun Tuo’s clinical trial expertise, covering CMC, non-clinical studies and clinical operations.
ProBio, a contract development and manufacturing organization (CDMO) focused on biologics and cell and gene therapies (CGT), has entered into a strategic collaboration with Kun Tuo, an IQVIA company and clinical research organization (CRO) in China. The partnership is intended to support Investigator-Initiated Trials (IITs) and clinical operations for global biopharmaceutical companies seeking to advance innovative therapies in China.
Under the collaboration, the companies will provide integrated support across Chemistry, Manufacturing and Controls (CMC), non-clinical studies and clinical operations. The companies said the combined offering is designed to simplify development pathways for biologics and advanced therapies and support clinical execution.
ProBio brings expertise in the development and manufacturing of biologics and CGT products, while Kun Tuo contributes clinical trial management capabilities and relationships with clinical sites. According to the release, the collaboration will provide coordinated support from early development and manufacturing through clinical assessment, including project management, site engagement and access to principal investigators.
ProBio said it has contributed to more than 1,000 GMP batches of cell and gene therapy products and supported more than 90 IND approvals and IIT programs across CGT pipelines. Kun Tuo, a wholly owned subsidiary of IQVIA in China, has approximately 1,000 employees and has supported more than 1,400 clinical trials for drugs and medical devices, according to the release.
“As the demand for innovative therapies continues to grow worldwide, developers increasingly seek partners who can provide seamless support across the drug development lifecycle.”
Allen Guo, CEO of ProBio
The companies said the collaboration is intended to help global sponsors navigate China’s clinical research environment through an integrated model connecting development, manufacturing and clinical execution.
