We are a global biopharmaceutical company focusing on oncology and auto-immune diseases with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide. Founded in 2010 and headquartered in Shanghai, we have built three global R&D facilities in Shanghai, Taipei and California collaborating with each other to ensure the highly productive and cost-efficient R&D processes. Discovering new ways to improve and extend patients’ lives by driving access to high-quality biologic medicines worldwide, we are committed to biosimilars, innovative monoclonal antibody (mAb) products and immuno-oncology combination therapies with proprietary anti-PD-1/PD-L1 mAbs as backbones on an integrated platform covering the entire product lifecycle from R&D, commercial-scale production to commercialisation. On September 25, 2019, we were successfully listed on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code 2696.HK.
Our 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 our vision and attracted by our 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.
We established our 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 EU QP and has received the Certificate of Good Manufacturing Practices for Pharmaceutical Products, People’s Republic of China. In December 2017, we concluded official agreement with 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.
Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) priority review and one product under Marketing Authorization Application (MAA) review, we have conducted over 20 clinical studies for 15 products and 8 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), our first product, has been granted NDA approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDAs under priority review by the NMPA. HLX02 is the first China-manufactured biosimilar to enter a global multi-centre Phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, HLX02's MAA was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbones in combination with chemotherapies and other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mAb). The global multi-centre clinical trials are ongoing in various countries and regions worldwide.