Email:
global@GCP-ClinPlus.com
A conversation with Ms. Ying Xiaowei, EVP of GCP ClinPlus,
on how US biotech companies can utilize China as a strategic accelerator for their global development plans.
Q: What is the strategic value for Us biotech companies considering Multi-Regional Clinical Trials (MRCTs) in including China?
A：Including China in an MRCT offers US biotech companies three significant strategic advantages: accelerated enrollment, cost efficiency, and high-quality data. China boasts a vast treatment-naïve patient population, which can significantly speed up patient enrollment and greatly alleviate the patient recruitment bottleneck common in global trials, substantially shortening the R&D cycle. Furthermore, leveraging the mature local clinical operations ecosystem enables highly competitive development costs while ensuring data quality meets international standards. The key to success lies in selecting a CRO partner that is not only familiar with local resources but can also ensure all processes and data comply with the requirements of international regulatory agencies like the FDA. GCP ClinPlus is precisely such a strategic partner you can trust. We are dedicated to efficiently and reliably transforming the potential of China's clinical resources into a competitive edge for accelerating global product development.
Q: GCP ClinPlus has extensive project experience in China. In which therapeutic areas are your services most attractive to global sponsors?
A：Our appeal to global sponsors is primarily concentrated in several fields such as oncology, hepatology,rare diseases, and ophthalmology. These areas not only have large patient populations and unique disease characteristics in China, but their clinical development capabilities are also highly aligned with global needs. Ophthalmology is a prime example—we have supported over 50 projects, including the development of an anti-VEGF drug that, after successful market launch, has become a blockbuster product with annual sales reaching billions of dollars. Additionally, we have deep expertise in oncology (with more than 550 cumulative projects), autoimmune diseases, and rare diseases.
As an experienced partner in the field of cell and gene therapy (CGT) and small nucleic acids, we have successfully completed over 80 related projects and are committed to providing professional support for innovative therapy companies. Currently, I am responsible for the overall operations of the CGT and Small Nucleic Acids Business Division. We have successfully supported the launch of China's first stem cell product and are also the first clinical CRO in China with experience in facilitating the successful FDA approval and marketing of small nucleic acid-based therapeutics. With these landmark project experiences, we have developed profound capabilities in the clinical development of innovative therapies, enabling us to offer strategic insights that go beyond conventional project management.
Q: Many biotech companies have concerns about regulatory and operational risks. How does GCp ClinPlus help mitigate risks when conducting projects in China?
Our service model is designed to systematically mitigate regulatory and operational risks in China for our global partners. Firstly, on the regulatory front, we act as your local guide. Our team is proficient in handling the entire China IND process, from protocol feasibility assessment to direct communication with the National Medical Products Administration (NMPA), ensurin g your project is designed for successful approval from the very start.
In operational execution, leveraging our deep site relationships and professional team, we can reduce site activation timelines by over 30%. Supported by more than 110 online tools and an AI-powered quality control system, we achieve efficiency improvements exceeding 40% in critical areas like data management. Crucially, all our operations are guided by the principle of generating data compliant with global submission standards. Our quality system ensures a 100% pass rate in NMPA inspections. The clinical data packages we deliver are robust and reliable, fully capable of supporting your successful submissions to the FDA or EMA, giving you full confidence in our data output.
