- ProBio and GCP ClinPlus have entered a strategic collaboration to support Investigator-Initiated Trials (IITs) in China through integrated development and clinical execution services.
- The partnership combines ProBio’s biologics and cell and gene therapy CDMO capabilities with GCP ClinPlus’s clinical trial and site management expertise to streamline trial execution for global biopharma companies.
ProBio Inc. and GCP ClinPlus have announced a strategic collaboration aimed at accelerating Investigator-Initiated Trials (IITs) in China and providing integrated clinical development and operational support for global biopharmaceutical companies. The partnership is intended to address challenges related to operational efficiency, regulatory compliance, and vendor management in China’s clinical research environment.
The collaboration combines ProBio’s expertise in biologics and cell and gene therapy (CGT) CDMO services with GCP ClinPlus’s capabilities in clinical trial execution and site management. The joint offering will support therapeutic modalities including in vivo CAR-T therapies, gene therapies, cancer vaccines, and gene-editing therapies.
According to the companies, ProBio has supported more than 40 IIT programs across multiple CGT pipelines, while GCP ClinPlus has participated in more than 80 CGT projects and maintains a network of principal investigators across public and private hospitals in China. The integrated model is designed to connect development activities with clinical execution, helping reduce operational complexity and accelerate study timelines.
“This marks an important step in how we support global innovators entering China. By bringing development and clinical execution closer together, we can help our clients move Investigator-Initiated Trials forward with greater speed, confidence, and simplicity.”
Allen Guo, Chief Executive Officer of ProBio
The companies stated that the collaboration integrates chemistry, manufacturing and controls (CMC), non-clinical development, regulatory affairs, clinical operations, pharmacovigilance, biostatistics, and project management into a coordinated service offering. The partnership is intended to simplify market entry for international biopharma companies and support the advancement of innovative therapies for patients in China.
