About HENLIUS Company

Fuhong Hanlin (2696.HK) is an international innovative biopharmaceutical company committed to providing high-quality and cost-effective innovative biopharmaceuticals to patients around the world. Its products cover the fields of tumors, autoimmune diseases, ophthalmology diseases, etc. Since its establishment in 2010, Fuhong Hanlin has built an integrated biopharmaceutical platform, with independent core capabilities for efficiency and innovation throughout the entire R&D, production and commercial operation industry chain. The company has R&D centers in Shanghai, China and California, USA. Production and quality control are carried out in accordance with international GMP standards. The production base in Xuhui, Shanghai has obtained GMP certification from China and the European Union. Under the company's mission and vision, Fu Hong Hanlin brought together a group of outstanding experts with rich industry experience in drug research and development, clinical, production, commercialization, pharmaceutical administration affairs, CMC, quality and compliance for leading multinational pharmaceutical companies. In 2016, Fuhong Hanlin built a biopharmaceutical production base with disposable bioreactors and other equipment as the core technology in Shanghai's Caohejing Emerging Technology Development Zone. Currently, the quality management system supporting the base has passed a number of on-site inspections or audits carried out by the China National Drug Administration, the European Medicines Agency, EU Quality Authorized Persons (QP), and international business partners, and has obtained GMP certification from China and the European Union. In order to further improve production capacity planning, Fuhong Hanlin also invested in the establishment of a biomedical industrialization base in Songjiang District, Shanghai. Among them, the Songjiang base (1) plans to build a production capacity of 24,000 L, and GMP production of clinical samples has already begun; the Songjiang base (2) covers an area of about 200 acres. After completion, it will become a large-scale domestic biomedical production base, which can meet the simultaneous production of more than 20 products after being fully put into operation. The base is designed in strict accordance with international GMP standards, making full use of new international technologies such as disposable production technology and continuous flow production technology, and has now completed the structural capping of the main production buildings. Fuhong Hanlin has prospectively laid out a diversified and high-quality product pipeline, covering more than 20 innovative monoclonal antibodies, and comprehensively promoted tumor immunotherapy based on its own anti-PD-1 monoclonal antibody, HLX10. Up to now, the company has successfully marketed 3 products — the first domestically produced biosimilar drug Hanlicon (rituximab); the first Chinese and European double batch of the domestically produced single biobiosimilar drug Hanquyou (trastuzumab, EU trade name: Zercepac); and the company's first autoimmune disease treatment product, Handayuan (adalimumab). Among them, Han Quyou pioneered the participation of Chinese pharmaceutical companies in the “World Cup” competition for single-antibiotic analogues, which is expected to bring more treatment options to HER2 positive breast cancer and gastric cancer patients around the world. In addition, applications for marketing registration of HLX04 bevacizumab and HLX01 rituximab for new rheumatoid arthritis are being reviewed. The company is also simultaneously carrying out more than 20 clinical trials on 10 products and 8 combination treatment plans worldwide, fully covering the mainstream biopharmaceutical market in Europe and the US and the markets of many emerging countries.