BioDuro first commenced operations in Shanghai in 2012 and recently completed an expansion of this office in 2016. Can you briefly introduce the company’s key milestones and the strategy behind expanding into China?

BioDuro was initially established in San Diego in 2005, and our first international expansion took place in China. We were particularly drawn to Beijing due to the abundant talent and resources available in the region. Our approach in China sets us apart from other Contract Research Organizations (CROs). While we offer a comprehensive range of services, including chemistry, antibody services, animal studies, DMPK (drug metabolism and pharmacokinetics), and pharmacology, BioDuro was founded with the concept of integrated discovery in mind. This approach has led to exponential growth, and in 2009, the American company PPD acquired BioDuro to strengthen its presence in the Chinese drug discovery space. This acquisition paved the way for our expansion into Shanghai in 2012. In 2015, our founding company, Bridgewest Group, reacquired BioDuro from PPD. Following that, we merged with Formex, a manufacturing pharma company specializing in formulations, to expand our manufacturing capabilities. In 2016, we launched the hTME-3DX Screen and Verify platform in Shanghai, which combines humanized 3D cell culture and patient-derived xenograft models across a set of 300 proprietary tumor models. More recently, we acquired Molecular Response, a U.S. translational oncology research platform, which has provided us with a vast biobank of viable tumor samples to offer to biotech and pharmaceutical companies.

How have CROs in China been impacted by the new emphasis placed on innovation, and how are you adapting your service offering to align accordingly?

China’s focus on generic drug development traditionally limited the role of CROs. However, the introduction of new regulatory policies aimed at fostering innovation has sparked a wave of change. Initially, our business from Chinese pharmaceuticals accounted for less than 5%, but it has since grown to 10-15%. We have observed increased demand for specific services, indicating the growing trend of innovation in China. As a CRO, BioDuro differentiates itself by acquiring and licensing new technology platforms from the U.S. and bringing them to China, providing accessible services locally. Transferring knowledge and emerging technologies from leading markets plays a vital role in developing our local markets. For instance, our San Diego facility specializes in compound solubility enhancements, and we are transferring this technology to China to offer the same service to Chinese companies. Furthermore, our hTME-3DX Screen and Verify platform, launched in Shanghai, was exclusively licensed from its developer, Molecular Response, in the U.S. This platform retains the structure of a tumor and combines clinically meaningful models derived from human patients, offering greater cost and time efficiencies in drug screening.

In which areas of the drug discovery space have you seen the most activity, and how is BioDuro responding to changes in demand?

Oncology has been a prominent area of emphasis for some time, largely due to substantial funding opportunities and easier navigation of regulatory approval processes. Over the past two years, there has been a revolution in immuno-oncology, with significant advancements in large molecule, small molecule, and CAR-T targets. At BioDuro, we aim to support these cutting-edge research projects. We adapt our services to align with changes in demand and ensure we remain at the forefront of the evolving drug discovery landscape.

Going forward, what vision does BioDuro have for itself, and what is your outlook for the development of the CRO sector in China as the pharmaceutical industry continues to emerge as a global leader?

This is an exciting time for the CRO sector, experiencing strong growth not only from big pharma but also from the successes in the biotech space. Our primary challenge now lies in sourcing enough quality talent to meet the increasing demand from our clients. BioDuro is considered among the second tier of CROs in terms of size, but we differentiate ourselves by offering comprehensive services from drug discovery to CDMO (Contract Development and Manufacturing Organization). We cover both small molecule and large molecule research, as well as T-cell therapeutics. As a U.S. company, we uphold high standards to ensure our clients feel comfortable working with us. Our vision is to achieve quality-driven growth by leveraging technology to support our integrated drug discovery model. Looking ahead, we anticipate significant development in the CRO sector in China, given the country’s emergence as a global leader in the pharmaceutical industry.