Technology

Technology

Established CMC Process and Manufacturing Capabilities


We have established a comprehensive quality system spanning R&D, production, and management, and continuously optimize it to ensure compliance with global regulatory requirements.
Simultaneously, we have proactively developed a scalable production infrastructure, enabling seamless and reliable support for our products from clinical trials to future large-scale commercial production, laying a solid foundation for sustainable long-term growth.

We have received IND approvals from both the CDE and FDA for several of our infectious disease vaccines and oncology therapeutics. All the work involved in these applications, including CMC development, quality assurance, and evaluations, are completed independently by our team. All clinical trial samples were manufactured at our own production facility in Hangzhou, China, which fully demonstrates the regulatory authorities' recognition of our quality system and manufacturing capabilities. 

 


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