Celebrating Another Milestone: Onradivir Tablets Approved
Celebrating Another Milestone: Onradivir Tablets Approved
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.Supporting Innovation: Our Partnership with Guangdong Raynovent BiotechnologyClient S...
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 ...
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 ...
China Accelerates Clinical Trials Approval to Just 30 Days
China Accelerates Clinical Trials Approval to Just 30 Days
Exciting news for global biopharma companies! China's NMPA is proposing to slash clinical trial review times from 60 to just 30 working days for novel medicines – a&...
Major Policy Boost for Innovative Drugs in China
Major Policy Boost for Innovative Drugs in China
China just made it easier—and more rewarding—for innovative therapies to access its vast market.On July 1, 2025, China’s National Healthcare Security Administration and National He...
FAQ: Conducting CGT Investigator-Initiated Trials (IITs) in China
FAQ: Conducting CGT Investigator-Initiated Trials (IITs) in China
For International Sponsors – Powered by GCP ClinPlus1. What is a CGT IIT in China?In China, CGT IITs are investigator-initiated trials typically conducted at leading hospitals. They are often used for early-stage exploration of new indications or treatment regimens using stem cells, CAR-T, or other ...