Covering a total area of about 11,000 square meters, Xuhui Facility is located in Shanghai Caohejing Hi-Technology Park. It has a total capacity of 24,000L. The facility and its accompanying quality management systems are certificated by China and the EU GMP. They have also passed multiple on-site inspections and audits conducted by the NMPA, EMA, the EU QP and the international commercial partners.
To further scale up the capacity, Henlius started the construction of Songjiang First Plant in 2019 and has commercial capacity of 24,000L. It passed GMP inspection in April, 2022, becoming the Company’s second facility certificated by GMP. It received QP declaration of its GMP equivalence to EU GMP in June, 2022.
Meanwhile, the construction of Songjiang Second Plant is also commenced. Covering about 130,000 square meters (200mu) with an investment amount of over ¥10 billion and located in the Western Technology Park of National-level Shanghai Songjiang Economic & Technological Development Zone as a part of G60 S&T Innovation Valley of Yangtze River Delta, Songjiang Second Plant, when fully operated, is expected to manufacture over 20 products and to become one of the largest biologic medicine manufacturing facilities in China. The facility strictly follows international GMP standards and adopts new technologies (continuous flow technology etc.) to align with the design criteria of biomedical automation, informatization, and intelligence (Pharmaceutical Industry 4.0). To date, for its Phase 1 project, the first and second stages aim to achieve a total capacity of 36,000L. They are expected to enter trial production and relevant verifications in the second half of 2022. In addition, plans are underway for the third stage. The construction of its 60,000L capacity is scheduled to commence in 2022.
Henlius leads the trend of adopting single-use technologies in China, particularly single-use bioreactors. Henlius strives to achieve further cost efficiency through the focus on developing continuous process technologies in-house, which is expected to significantly bring down per-unit manufacturing costs and reduce liquid and solid wastes pollution, while at the same time significantly increasing productivity. In 2021, Henlius successfully launched China’s first continuous manufacturing clinical production workshop to achieve end-to-end continuous production and thus improving productivity with stable and controllable quality. Meanwhile, steady progress has been made in the localization of critical consumables to better mitigate the risk of material supply against the global backdrop.