Supporting Amoytop Biotech's Breakthrough Innovation in Pediatric Endocrinology
Executive Summary
On May 29, 2025, Amoytop Biotech achieved a groundbreaking milestone with NMPA approval of Yipeisheng® —the world's first 40kD Y-type PEGylated long-acting growth hormone. As Amoytop's strategic clinical operations partner, GCP ClinPlus delivered comprehensive biostatistics and regulatory support that was instrumental to this historic approval, marking our second major success in China's growth hormone market.
The Challenge
Developing long-acting growth hormone therapies presents unique complexities:
● Regulatory Innovation: First-in-class mechanism requiring novel regulatory pathways
● Pediatric Population: Specialized protocols for children aged 3+ with growth hormone deficiency
● Market Competition: Need to demonstrate clear advantages over existing treatments
● Timeline Pressure: Accelerated development goals in a competitive landscape
Our Strategic Partnership Approach
Seven-Year Partnership Excellence (2018-2025)
1. High-Efficiency Execution
● 87-person cross-functional team spanning data management, biostatistics, and programming
● 8,176 hours invested supporting 35 critical submissions including IND and NDA filings
● End-to-end project support from initiation through commercial approval
2. Precision Data Management & Analysis
● 434 patient datasets managed with zero critical findings during regulatory review
● Phase III study completion with exceptional data quality and integrity
● 527+ overtime hours dedicated to pre-NDA meetings and registration dossier preparation
3. Multi-Dimensional Regulatory Support
● Integrated biostatistics and regulatory affairs services accelerating approval timelines
● Comprehensive submission support beyond data analysis to include regulatory strategy
● Seamless NMPA interaction ensuring efficient regulatory pathway navigation
Comprehensive Service Integration Our seven-year partnership (2018-2025) demonstrates sustained excellence across all critical development phases:
● Data Management Excellence: Zero critical regulatory findings across 434 patient datasets
● Statistical Programming: Advanced analytics supporting complex long-acting formulation requirements
● Regulatory Strategy: 35 successful submissions including complex IND and NDA filings
● Timeline Optimization: Strategic overtime allocation (527+ hours) ensuring submission deadlines
● Quality Assurance: Integrated QC processes maintaining international standards throughout
Comprehensive Service Portfolio
Beyond Yipeisheng®, our collaboration with Amoytop spans multiple innovative therapies:
Peijin® - Next-Generation Neutropenia Treatment
● Revolutionary "white blood cell booster" requiring only 1/3 the dosage of competitors
● Enhanced efficacy with reduced bone marrow risk profile
Pagebine® - Viral Hepatitis Innovation
● Proprietary treatment for viral hepatitis with complete intellectual property ownership
● Multi-regional patent protection (China, Europe, US, Japan)
Proven Track Record & Capabilities
Industry-Leading Team
● 400+ professionals with deep China clinical operations expertise
● 17+ years average experience among core leadership team
● 31% of staff with 5+ years specialized clinical research experience
Global Excellence
● 200+ bilingual Chinese-English professionals enabling seamless international collaboration
● 150+ projects launched annually across therapeutic areas
● 3 products supported to FDA/EMA approval, demonstrating global regulatory competency
Systematic Quality Assurance
● 600+ standardized training modules ensuring consistent service excellence
● 60+ % repeat client rate indicating superior client satisfaction and trust
● 210+ successful NDAs supported across our portfolio
Innovation Impact
For Patients: Yipeisheng® offers more convenient dosing and improved safety profile for children with growth hormone deficiency, addressing a critical unmet medical need in pediatric endocrinology.
For Industry: This approval validates China's growing leadership in biopharmaceutical innovation and demonstrates the effectiveness of strategic CRO partnerships in complex therapeutic development.
For Global Development: Success showcases how specialized local expertise can accelerate innovative therapy development while maintaining international quality standards.
Looking Forward
From Jinsai® to Yipeisheng®, our consecutive successes in growth hormone development demonstrate our ability to deliver consistent excellence across therapeutic areas and development phases. With 2,200+ projects experience and a proven systematic approach, we continue empowering biotech partners to transform innovative science into life-changing therapies for patients worldwide.
Our comprehensive capabilities span the full development lifecycle—from early-phase clinical design through commercial approval—positioning us as the strategic partner of choice for companies seeking to navigate China's dynamic regulatory environment while maintaining global development standards.
For more information about our clinical operations capabilities and therapeutic expertise, contact our business development team at global@gcp-clinplus.com