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 and autoimmune 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 three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).
The co-founders, Dr. Scott Liu and Dr. Wei Dong Jiang, each possesses over 20 years of hands-on experience in developing therapeutic drugs and holds leadership positions in R&D, manufacturing and quality management at world-renowned international biopharmaceutical companies. Inspired by the vision and attracted by the corporate culture, a team of highly-skilled talents are thus assembled with extensive experience across drug development, CMC, plant design, pharmaceutical production management, quality and compliance, clinical development, regulatory affairs, commercialisation and finance 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 EU QP 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 monocolonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, in addition to汉利康 (HLX01, rituximab) launched commercially and two products (HLX02 trastuzumab and HLX03 adalimumab) under New Drug Application (NDA) review to be potentially launched within 2020, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions. Moreover, the business partner Accord submitted a Marketing Authorisation Application (MAA) for HLX02 to European Medicines Agency (EMA). In May 2020, the Committee for Medicinal Products for Human Use (CHMP) of EMA has adopted a positive opinion on the MAA for HLX02, which is expected to become the first China-manufactured biosimialr to be launched in the EU markets.