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 two 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. In December 2017, Henlius concluded an official agreement with the People's Government of Songjiang, Shanghai, to locate the second manufacturing facility in Songjiang. Covering 130,000 square meters and located in the Western Technology Park of National-level Shanghai Songjiang Economic & Technological Development Zone, Songjiang Manufacturing Facility is expected to manufacture 20-30 products and to become a large-scale biologic medicine manufacturing facility in China when fully operated. It strictly follows international GMP standards, adopts new technologies to ensure quality and reduce cost, meets the international level of biomedical automation, informatization, and intelligence (Pharmaceutical Industry 4.0) and features low carbon, energy conservation and eco-protection.
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® (HLX01, rituximab injection) , the first biosimilar approved in China, 汉曲优® (HLX02, trastuzumab injection, Zercepac® in the EU), the first Chinese mAb biosimilar launched in both China and Europe and 汉达远® (HLX03, adalimumab injection), the Company's first product for the treatment of autoimmune diseases. 汉曲优® will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. 汉达远® is the first China-developed adalimumab biosimilar that is manufactured in a China and Europe GMP certificated manufacturing site. In addition, HLX01 (rituximab injection) indicated for rheumatoid arthritis and HLX04 (bevacizumab 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.