In a move set to reshape the drug development landscape in East Asia, global Contract Development and Manufacturing Organization (CDMO) ProBio has announced a strategic partnership with Kun Tuo, a clinical research organization (CRO) backed by IQVIA. The collaboration is designed to create a unified, end-to-end service model, specifically aimed at accelerating investigator-initiated trials (IITs) and clinical operations for biopharmaceutical companies operating within the Chinese market.
By integrating ProBio’s specialized manufacturing capabilities with Kun Tuo’s extensive clinical trial infrastructure, the partnership addresses a critical bottleneck in the pharmaceutical sector: the fragmentation of the drug development lifecycle. Historically, sponsors have had to manage disparate vendors for chemistry, manufacturing, and controls (CMC), non-clinical studies, and clinical execution. This new alliance streamlines these processes into a single pathway, intended to reduce time-to-market for complex biologics and advanced cell and gene therapies (CGTs).
“Developers increasingly seek partners who can provide seamless support across the drug development lifecycle,” said ProBio CEO Allen Guo. “This strategic collaboration marks a significant milestone in ProBio’s mission to provide end-to-end solutions for our global customers. We can now offer a seamless pathway from manufacturing to clinical execution, accelerating investigator-initiated trials in China.”
The partnership leverages the specific strengths of both organizations. ProBio brings a high-velocity manufacturing platform to the table, boasting a track record that includes the production of over 1,000 Good Manufacturing Practice (GMP) batches of CGT products. Their regulatory experience is equally robust, having already supported more than 90 Investigational New Drug (IND) approvals and various IIT programs.
Complementing this, Kun Tuo provides a massive operational footprint. As an IQVIA company, it commands a workforce of approximately 1,000 professionals and has deep-seated expertise in managing the regulatory and logistical complexities of the Chinese clinical landscape. Having supported over 1,400 clinical trials for drugs and medical devices, Kun Tuo is uniquely positioned to handle the rigorous demands of advanced therapy trials.
“We are excited to partner with ProBio, a leading CDMO in this space,” said Linda Wang, General Manager of Kun Tuo. “This allows us to combine Kun Tuo’s clinical development expertise in cell and gene therapy with ProBio’s robust manufacturing platform. It creates a comprehensive solution that addresses the growing demand for integrated IIT services in China. Together, we will help sponsors navigate the complexities of China’s clinical landscape with greater efficiency and confidence.”
For global biopharmaceutical firms, the collaboration offers a simplified entry point into China’s rapidly expanding healthcare sector. By bridging the gap between bench-side manufacturing and bedside clinical execution, ProBio and Kun Tuo aim to ensure that innovative therapies can reach patients more reliably, ultimately fostering a more efficient ecosystem for global medical innovation.
Disclaimer: This content is auto-generated for informational purposes only.
Source: Read Original News
