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Cases & Articles
Frequently Asked Questions: Clinical Operations in China for International Biopharmas
08/18/2025
Frequently Asked Questions: Clinical Operations in China for International Biopharmas
Regulatory Framework & Approval ProcessQ: What is the regulatory pathway for international biotechs to conduct clinical trials in China?A: International biotechs must submit an Investigational New...
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FAQ: Conducting CGT Investigator-Initiated Trials (IITs) in China
08/18/2025
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 ...
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Major Policy Boost for Innovative Drugs in China
08/18/2025
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 Health Commissio...
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Study Kickoff Announcement | Treg Cell Therapy for ALS at Tiantan Hospital
08/18/2025
Study Kickoff Announcement | Treg Cell Therapy for ALS at Tiantan Hospital
We are excited to announce the official launch of a Phase 1 clinical trial of Treg cell therapy for Amyotrophic Lateral Sclerosis (ALS), sponsored by NovaBio Therapeutics, at the prestigious Tiantan H...
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GCP ClinPlus Secures Series B Funding!
08/18/2025
GCP ClinPlus Secures Series B Funding!
We are proud to announce the successful completion of our Series B financing, led by Taikun Fund, one of the largest life science investment funds in China, with participation from multiple well-known...
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Case Study: Gene Therapy for Beta-Thalassemia (RM-001)
08/18/2025
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 ...
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