Partnership combines manufacturing, development and clinical operations expertise to accelerate Investigator-Initiated Trials and clinical execution in China

HOPEWELL, N.J., Aug. 16, 2026 /PRNewswire/ — ProBio, a leading global contract development and manufacturing organization (CDMO) focused on biologics and cell and gene therapies (CGT), today announced a strategic collaboration with Kun Tuo, an IQVIA company and leading clinical research organization (CRO) in China. The partnership aims to accelerate Investigator-Initiated Trials (IITs) and streamline clinical operations for global biopharmaceutical companies seeking to advance innovative therapies in China.

Through the collaboration, ProBio and Kun Tuo will provide integrated support spanning Chemistry, Manufacturing and Controls (CMC), non-clinical studies, and clinical operations. The combined offering is designed to simplify development pathways for biologics and advanced therapies while enabling faster, more efficient clinical execution.

A deliberate alliance has been formed, bringing together ProBio’s established expertise in the development and manufacturing of biologics and cell and gene therapies (CGT) with Kun Tuo’s extensive capabilities in managing clinical trials. Collaborating, these organizations will provide customers with a unified strategy for advancing therapeutic candidates. This approach will guide candidates from their initial development stages through their clinical assessment, aiming to simplify operational processes and shorten program timelines. Further information about ProBio’s CGT CDMO services is available via this link: Gene Therapy CDMO | Cell and Gene Therapy | CGT CDMO Manufacturing – ProBio CDMO

“As the demand for innovative therapies continues to grow worldwide, developers increasingly seek partners who can provide seamless support across the drug development lifecycle,” said Allen Guo, CEO of ProBio. “This strategic collaboration with Kun Tuo marks a significant milestone in ProBio’s mission to provide end-to-end solutions for our global customers. By integrating our CDMO capabilities in CGT and biologics with Kun Tuo’s world-class clinical operations expertise, we can now offer a seamless pathway from manufacturing to clinical execution, accelerating Investigator-Initiated Trials in China and bringing innovative therapies to patients faster.”

ProBio has established a strong track record supporting advanced therapy programs, having 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 a range of CGT pipelines. Through this collaboration, ProBio customers will gain direct access to clinical operations support and site engagement resources, enabling a smoother transition from preclinical and manufacturing activities into clinical development. 

Kun Tuo, a wholly owned subsidiary of IQVIA in China, brings approximately 1,000 employees and experience supporting more than 1,400 clinical trials for drugs and medical devices. Leveraging deep relationships with clinical sites and backed by IQVIA’s global clinical development expertise, Kun Tuo helps sponsors identify appropriate study sites and execute trials with speed, quality, and regulatory confidence.

“We are excited to partner with ProBio, a leading CDMO in the advanced therapies space,” said Linda Wang, General Manager of Kun Tuo. “This collaboration allows us to combine Kun Tuo’s clinical development expertise in cell and gene therapy with ProBio’s robust manufacturing platform, creating 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.”

The collaboration creates a connected ecosystem that links development, manufacturing, and clinical execution, offering biotech and biopharmaceutical companies a more streamlined route into China’s rapidly evolving clinical research environment. Customers will benefit from coordinated project management, reduced referral friction between development and clinical phases, and accelerated access to sites and principal investigators.

By combining complementary capabilities while maintaining each organization’s core specialization, ProBio and Kun Tuo are creating a differentiated model for supporting clinical innovation. The partnership is expected to enhance customer retention, generate new opportunities for both organizations, and strengthen their ability to support global sponsors seeking integrated solutions for advanced therapy development and clinical execution.

About ProBio

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

About Kun Tuo

Kun Tuo is the wholly owned subsidiary of IQVIA in China, with approximately 1000 employees and experience in over 1400 clinical trials of various areas for drugs and medical devices. Kun Tuo maintains collaborative partnership with sites, with support by IQVIA global operation experience and professional knowledge, which can help companies select the most appropriate sites and conduct clinical trials with quick progress and high quality.

For more information, visit https://www.kuntuo-cro.com/

Head of EU & US Regional Marketing: Tracy Humphries [tracy.humphries@probiocdmo.com]

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SOURCE ProBio Inc.