Email:
global@GCP-ClinPlus.com
We're thrilled to announce that Onradivir Tablets (Anruiwei®), supported by our biometrics services, received NMPA approval on May 22, 2025, becoming the world's first influenza RNA polymerase PB2 protein inhibitor.
Our comprehensive biometrics services have been instrumental in supporting Guangdong Zhongsheng Pharmaceuticals' remarkable journey from research to market approval for two groundbreaking innovative drugs. This partnership demonstrates our capability to handle complex clinical development programs for first-in-class therapeutics.
Guangdong Raynovent Biotechnology faced the complex task of developing innovative drugs targeting novel mechanisms of action. These included:
● Leritrelvir (2023): A 3CLpro inhibitor representing a new approach to antiviral treatment
● Onradivir Tablets (approved yesterday, May 22, 2025): The world's first influenza RNA polymerase PB2 protein inhibitor
Both drugs required sophisticated clinical trial designs, rigorous statistical analyses, and robust data management to support regulatory submissions for these unprecedented therapeutic approaches.
We provided comprehensive biometrics support including:
Data Management
● Robust clinical data capture and validation systems
● Quality assurance protocols ensuring data integrity throughout multi-phase clinical programs
● Regulatory-compliant database design and maintenance
Biostatistics
● Statistical design for head-to-head comparative trials
● Complex endpoint analysis for novel efficacy measures
● Risk-benefit assessment strategies for innovative mechanisms
Statistical Programming
● Advanced analytical programming for complex clinical datasets
● Regulatory submission-ready statistical outputs
● Custom analysis solutions for unique trial requirements
For the Onradivir Tablets clinical program, GCP ClinPlus assembled a dedicated 56-member professional team covering data management, biostatistics, and statistical programming. Our commitment to excellence is reflected in:
● 6,018 total hours invested across the program
● 243 overtime hours demonstrating our dedication to project success
● 27 professional submissions including Dry-run, Final-run, and ad-hoc analyses
● Strict adherence to CDISC standards throughout all deliverables
Our proprietary Dynamic Data Integration Platform enabled:
● Intelligent end-to-end management from data collection through statistical analysis
● Significantly enhanced research efficiency and quality
● Real-time data monitoring and quality assurance
Our biometrics expertise supported a successful head-to-head trial against oseltamivir, demonstrating:
● 39% reduction in median time to symptom relief vs. placebo
● 44% improvement specifically in H1 subtype influenza patients
● 10% better performance compared to the established standard of care (oseltamivir)
● Statistically significant virological endpoints proving superior viral clearance
Both drugs achieved successful NMPA approval, with our biometrics support contributing to:
● Streamlined regulatory submissions
● Robust statistical evidence packages
● Compliance with evolving regulatory requirements for innovative therapeutics
Our partnership with Zhongsheng has resulted in two market-changing approvals:
● Leritrelvir: Expanding antiviral treatment options with a novel mechanism
● Onradivir Tablets: Becoming the world's first PB2 protein inhibitor, addressing critical unmet needs in influenza treatment where current options show limited effectiveness
As China's leading international clinical CRO, this three-year collaboration showcases our ability to:
● Navigate complex regulatory pathways for innovative drugs
● Support novel trial designs for first-in-class therapeutics
● Deliver consistent, high-quality biometrics services across multiple programs
● Adapt our expertise to emerging therapeutic areas and mechanisms
Our Competitive Advantages
● Professional statistical expertise with deep therapeutic knowledge
● Dynamic data monitoring platform for real-time insights
● International compliance systems meeting global regulatory standards
● Rich drug development experience across diverse therapeutic areas
Our "precision-driven approach" provides the analytical rigor needed for breakthrough therapies, enabling efficient regulatory approval and faster patient access to life-changing treatments.
Our proven track record with Guangdong Raynovent Biotechnology demonstrates our commitment to advancing innovative medicine through expert biometrics support, helping bring life-changing therapies to patients worldwide.
With 22 years of industry experience, GCP ClinPlus has established itself as a trusted partner in clinical development, successfully supporting over 2,200 projects for more than 500 global clients.
Our Services
● Full Service Outsourcing (FSO) and Functional Service Provider (FSP) solutions for clinical operations in China
● Global biometrics services with strong presence in New Jersey, US
● Deep local knowledge and expertise in navigating China's regulatory landscape
● Comprehensive support from early-phase through commercialization
Quality & Compliance Excellence
● CDISC Platinum Member - demonstrating our commitment to industry standards
● PHUSE Active Contributor - actively advancing statistical and data science practices
● Perfect regulatory track record - passed all NMPA and FDA inspections with no major findings
● Proven expertise in supporting innovative, first-in-class therapeutics
Partner with Us
Ready to advance your clinical development program? We offer free initial consultations to discuss your project needs and provide strategic recommendations tailored to your development goals.
Contact us today at global@gcp-clinplus.com or +1 (609) 255-3581 to learn how our proven biometrics expertise can accelerate your path to regulatory approval.