Henlius now has 3 manufacturing sites: Xuhui Site, Songjiang Site I and Songjiang Site II. With a total capacity of 84.000 Liters, it has delivered over 1,300 batches of GMP commercial batches and maintains stable supply in China, North America, Southeast Asia, Europe and Latin America.
Henlius Xuhui Site, GMP-certified by Chin and EU regulatory agencies, has a total commcercial capacity of 24,000L Henlius Songjiang Site I, GMP-certified by China, EU and US regulatory agencies, also has a total commcercial capacity of 24,000L. Henlius Songjiang Site II covers about 130,000 square meters (200mu) , with a total capacity of 36,000L for the first and second stage of Phase 1. It is GMP-certified by EU and US regulatory agencies. Its capacity covers drug substance, liquid filling, pre-filled syringes and ADC conjugation. The site adopts new technologies to align with the design criteria of biomedical automation, information, and intelligence. In 2025, the site was awarded the National Integration of Informatization and Industrialization (Two-Integration) Management System AA Certification and was recognized as a Shanghai Advanced-Level Smart Factory. Currently, all of the Company’s operating manufacturing sites have obtained ISO 9001 Quality Management System, ISO 14001 Environmental Management System, and ISO 45001 Occupational Health and Safety Management System certifications.
Henlius continues to pioneer continuous manufacturing processes and, in 2021, launched China’s first continuous manufacturing clinical production workshop to achieve end-to-end continuous production. Henlius actively implements Business Intelligence (BI) systems to enable real-time monitoring of key production, quality, and supply chain indicators, along with visualized risk forecasting. The company also promotes the localization and optimization of critical production materials and consumables, continuously enhancing operational sustainability.
