We are a leading biopharmaceutical company in China focusing on oncology and autoimmune diseases with the vision to offer high-quality, affordable and innovative biologics for patients worldwide. Founded in 2010 and headquartered in Shanghai, we have built an integrated and efficient global R&D platform with key 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 biologics worldwide, we are committed to biosimilar, innovative monoclonal antibody (mAb) products and immuno-oncology combination therapies with proprietary anti-PD-1/PD-L1 mAbs as backbone on an integrated platform covering the entire product lifecycle from R&D, commercial-scale production to commercialization. On September 25, 2019, We were successfully listed and commenced trading 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 top 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, commercialization and finance at leading multinational pharmaceutical companies.
We 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 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 the largest biologics 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) review and one product under Marketing Authorization Application (MAA) review, we have conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), our first product, has been granted 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-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, MAA for HLX02 was accepted to review by EMA.