GCP ClinPlus: Pioneering China's First Stem Cell Therapy Approval
GCP ClinPlus: Pioneering China's First Stem Cell Therapy Approval
Executive SummaryGCP ClinPlus successfully delivered comprehensive clinical research services that led to the groundbreaking approval of China's first stem cell therapy for acute Graft-versus-Host Disease (aGVHD). Through strategic management, regulatory expertise, and clinical excellence, our team ...
China's Drug Approval Landscape is Accelerating: Partner with GCP ClinPlus to Navigate this Dynamic Market
China's Drug Approval Landscape is Accelerating: Partner with GCP ClinPlus to Navigate this Dynamic Market
Record-Breaking Innovation in Chinese PharmaceuticalsChina's pharmaceutical landscape is experiencing unprecedented growth, with the National Medical Products Administration (NMPA) recently reporting 48 first-in-class innovative drug approvals in the past year—the highest number in five years and a ...
FDA's Paradigm Shift_ An Opportunity for Accelerated Clinical Trials in China
FDA's Paradigm Shift_ An Opportunity for Accelerated Clinical Trials in China
Breaking News (April 10, 2025): The FDA has announced a groundbreaking initiative to phase out animal testing requirements for monoclonal antibodies and other drugs. This major policy shift will:• Implement New Approach Methodologies (NAMs) including AI-based computational models and organoid testin...
China's CGT Market Opportunity: Accelerating Global Cell & Gene Therapy Development
China's CGT Market Opportunity: Accelerating Global Cell & Gene Therapy Development
Executive SummaryThe global cell and gene therapy (CGT) market is experiencing unprecedented growth, projected to expand from USD 25.03 billion in 2025 to approximately USD 117.46 billion by 2034, with a CAGR of 18.7%. Amid this expansion, China has emerged as a crucial market and development hub fo...
Unlocking Opportunities: Ophthalmology Clinical Trials in China
Unlocking Opportunities: Ophthalmology Clinical Trials in China
Executive SummaryChina's ophthalmology market stands at the precipice of transformation, presenting exceptional opportunities for global pharmaceutical and medical device companies. With one of the world's largest patient populations, favorable government policies, robust infrastructure, and efficie...
Accelerating Innovative Cancer Treatment to Approval Executive Summary
Accelerating Innovative Cancer Treatment to Approval Executive Summary
GCP ClinPlus delivered comprehensive biostatistical services for an innovative oral  targeted therapy inhibiting cancer cell proliferation, specifically developed for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Our end-to-end biostatistical support accelerated the produc...
Case Study: Gene Therapy for Beta-Thalassemia (RM-001)
Case Study: Gene Therapy for Beta-Thalassemia (RM-001)
Client OverviewBioGene-X is a leading gene editing therapeutics company in China, driven by cutting-edge gene editing technology and dedicated to pioneering innovative treatments. The company was among the first internationally to explore gene editing for treating genetic disorders and has achieved ...