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Japan
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As demand for Investigator-Initiated Trials (IITs) continues to grow, biopharma sponsors frequently encounter challenges related to operational efficiency, regulatory compliance, and fragmented vendor management in China. To address these complexities and streamline the pathway from early development to clinical operations, ProBio Inc. and GCP ClinPlus today announced a strategic collaboration designed to accelerate Investigator-Initiated Trials (IITs) in China and provide integrated, end-to-end clinical and development solutions for global biopharma customers.
This collaboration unites ProBio Inc.'s deep expertise in biologics and cell and gene therapy (CGT) CDMO services with GCP ClinPlus's robust capabilities in clinical trial execution and site management across China. The combined offering supports cutting-edge therapeutic modalities, including:
This unified service model simplifies clinical execution in China and accelerates study timelines. ProBio Inc. contributes extensive experience in early development and translational science, having supported over 40 IIT programs across diverse CGT pipelines. Complementing this, GCP ClinPlus brings significant clinical execution expertise, with a track record spanning more than 80 CGT projects and a well-established network of principal investigators across leading public and private hospitals in China.
The partnership creates tangible value by reducing the disconnect between development and clinical execution. Both companies combine excellence in development, regulatory affairs, and clinical operations, covering project management, clinical monitoring, pharmacovigilance, and biostatistics, to ensure higher-quality and more efficient trial execution. This coordinated, two-party model offers international biopharma companies a simplified entry point into China's clinical research ecosystem, reducing vendor complexity while accelerating local trial execution.
Allen Guo, CEO of ProBio, stated, "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."
By integrating CMC, non-clinical studies, and clinical operations into one coordinated solution, the collaboration accelerates IIT start-up timelines and enables more efficient engagement with global biotech partners. Ultimately, this strategic alliance aims to help bring innovative, potentially life-saving therapies to patients faster. This partnership underscores a shared commitment to advancing therapeutic development and improving patient access to innovative treatments in China.
ProBio is a global Contract Development and Manufacturing Organization (CDMO) enabling biotech and pharmaceutical companies to advance the development and manufacturing of next‑generation therapies. With deep expertise in cell and gene therapy, ProBio delivers integrated, end‑to‑end solutions across mRNA, plasmid DNA, viral vectors, and in vivo CAR‑T therapies.
ProBio’s scalable, GMP‑compliant platforms support partners from early development through commercial manufacturing, helping accelerate timelines and de‑risk complex programs. Through a collaborative, risk‑sharing model, ProBio also offers flexible options for licensing and co‑development, empowering partners to efficiently navigate the scientific and regulatory challenges of advanced therapeutics.
For more information, visit www.probiocdmo.com.
GCP ClinPlus is a leading full-service CRO with more than 23 years of experience supporting global clinical development. Headquartered in China with an international presence, the company provides end-to-end clinical trial services spanning biometrics, clinical operations, site management, and regulatory submissions.
Since 2003, it has executed over 2,300 projects and supported numerous IND, NDA, and global filings across FDA, EMA, and NMPA. With dedicated expertise across CGT and key therapeutic areas, a strong network of global partners, and a highly qualified team, GCP ClinPlus combines scientific rigor, operational scale, and innovation to help biopharma companies accelerate development and achieve regulatory success worldwide.
To learn more about GCP ClinPlus, please visit https://www.gcpclinplus.com
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