Three major missions of the platform
- Security - Protecting the Sovereignty of Genetic Resources
- International Competition - Seizing Global Discourse Power
- National Standard - Unified Industry 'Gold Standard'
Production
Internationalization
Internationalization
World class biopharmaceuticals
Source of Innovation
Source of Innovation
Research and development into pharmaceuticals
CGT New Drug Development
Conversion ability
Conversion ability
Storage standardization
Vertical human genetic resources
Management system
Management system
Established cell bank
GMP platform under construction
Plan IIT pilot program
Realize the paradigm shift from passive international integration to active rule definition
Failed treatment, stifled innovation, high economic cost
The lack of high-level traceability, testing, and quality control systems can pose safety and efficacy risks to patients- The lack of advanced therapeutic drugs and high-level CDMO will lead to technological bottlenecks and cost control
- The imperfect declaration system has led to a significant increase in regulatory communication costs
VS
Cost reconstruction, timeliness revolution, ecological reshaping
Establish a comprehensive quality control system for advanced therapeutic drugs throughout the entire chain- Introducing a team of FDA biopharmaceutical reviewers and establishing a "Gold Standard" declaration service center
- Create a special regulatory demonstration zone for cell therapy products
