Ms. Ying Xiaowei, EVP of GCP ClinPlusA 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 and effectively navigate the complex challenges in this field.Q:Many biotech companies have concerns about regulatory and operational risks. How does GCP ClinPlus help mitigate risks when conducting projects in China?A: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), ensuring 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.【关于普瑞盛】普瑞盛(杭州)医药科技开发股份有限公司自2003年成立以来,立足中国、布局全球,是一家以AI为引擎的全流程智能CRO。公司以“AI赋能,让每一份数据都指向希望”为核心理念,凭借23年深厚的行业积淀,构建了覆盖临床研究全链条的服务体系。我们以自主研发的临研智能Clinx平台为运营中枢,深度融合AI技术,为全球合作伙伴提供符合国际标准、更智能、更高效、更可预测的高质量临床研究解决方案,持续提升临床研究的效率与质量。公司在全治疗领域具备广泛的服务能力,并深度聚焦小核酸、细胞与基因治疗(CGT)等前沿方向,在医学事务、临床研究项目管理、数据管理与生物统计分析等核心服务板块,拥有深厚的专业积累与完善的质量控制体系,全方位保障临床研究的高效推进与卓越成果。作为国内首款干细胞药物上市的助力者、首家成功支持小核酸药物完成FDA申报的CRO,我们在创新疗法开发领域积累了标杆性项目经验。迄今为止,公司已成功为500多家国内外医药企业提供超过2300项临床研究全流程服务,执行了200多项国际多中心临床试验(MRCT),助力4款新药在美国获批,并推动220余款药物产品成功上市。作为中国医药创新研发的见证者与推动者,普瑞盛以“AI化与国际化”为双轮驱动战略,积极构建“平台赋能+生态合作”的智能CRO新生态,持续为全球医药创新注入智能动力。