Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has R&D facilities in Shanghai and California as well as a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).
Inspired by the vision and attracted by the corporate culture, a team of highly-skilled talents are thus assembled with extensive experience across research & development, clinical development, manufacturing, commercialisation, regulatory affairs, CMC, quality and compliance, etc. at leading multinational pharmaceutical companies.
Henlius established the first manufacturing facility featuring the core technology of single-use bioreactors in Shanghai Caohejing Hi-Technology Park in 2016. The facility has passed the multiple on-site inspections conducted by the National Medical Products Administration (NMPA), European Medicines Agency (EMA), EU QP (Qualified Person) and was certificated by China and the EU GMP. To further scale up the production capacity, Henlius has also located manufacturing facilities in Songjiang District. Songjiang Manufacturing Facility (First Plant) has a planned production capacity of 24,000L. GMP production for clinical samples has been conducted. Songjiang Manufacturing Facility (Second Plant) covers about 130,000 square meters (200mu). When fully operated, it is expected to manufacture over 20 products simultaneously, becoming the largest biologic medicine manufacturing facility in China. It strictly follows international GMP standards and adopts new technologies such as continuous manufacturing technology, single-use technology etc. The structure of the main production building of Phase 1 project has been completed.
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched three products, 汉利康® (rituximab injection) , the first biosimilar approved in China, 汉曲优® (trastuzumab injection, Zercepac® in the EU), the first Chinese mAb biosimilar launched in both China and Europe and 汉达远® (adalimumab injection), the Company's first product for the treatment of autoimmune diseases, among which 汉曲优® will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In addition, HLX01 (rituximab injection) indicated for rheumatoid arthritis, HLX04 (bevacizumab injection) and HLX10 (serplulimab injection) were accepted for New Drug Application (NDA) review by the NMPA. Henlius has also conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.