HENLIUS

Fuhong Hanlin (2696.HK) is an international innovative biopharmaceutical company committed to providing high-quality and affordable innovative biopharmaceuticals to patients around the world. Its products cover the fields of tumors, autoimmune diseases, eye diseases, etc. Since its establishment in 2010, Fuhong Hanlin has built an integrated biopharmaceutical platform, and its independent core capabilities of efficiency and innovation span the entire R&D, production and commercial operation industry chain. The company has R&D centers in Shanghai, China and California, where 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, Fuhong 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, Fu Hong Han Lin built a biopharmaceutical production base with disposable bioreactors and other equipment as the core technology in the Caohejing New Technology Development Zone in Shanghai. Currently, the quality management system supporting the base has passed a number of on-site inspections or audits carried out by the China Drug Administration, the European Medicines Administration, the EU Quality Authorized Person (QP) and international business partners, and has obtained Chinese and EU GMP certifications. In order to further improve the production capacity plan, Fuhong Hanlin also invested in the establishment of a biomedical industrialization base in the Songjiang district of Shanghai. Among them, the Songjiang base (1) plans to build a production capacity of 24,000L and has now begun GMP production of clinical samples; the Songjiang base (2) covers an area of about 200 acres. After completion, it will become a large-scale biomedical production base in China, which can meet the simultaneous production of more than 20 products after being fully put into operation. The base was designed in strict accordance with international GMP standards, making full use of new international technologies such as single-use production technology and continuous flow production technology. The structural capping of the main production building has now been completed.

Fuhong Hanlin has prospectively laid out a diversified, high-quality product pipeline, covering more than 20 innovative monoclonal antibodies, and comprehensively promoting tumor immunotherapy based on its own anti-PD-1 monoclonal antibody HLX10. Up to now, the company has successfully launched 3 products — the first domestically produced biosimilar drug Hanlikon (rituximab); the first Chinese and European batch of domestic single-antibiotic analogue Hantriumab (trastuzumab, EU trade name: Zercepac); and the company's first autoimmune disease treatment product, Handazumab (adalimumab). Among them, Han Quyou pioneered the participation of Chinese pharmaceutical companies in the single-antibiotic “World Cup” competition, which is expected to bring more treatment options to patients with HER2-positive breast cancer and stomach cancer around the world. In addition, the marketing registration applications for HLX04 bevacizumab and HLX01 rituximab for new indications for rheumatoid arthritis are being reviewed. The company is also simultaneously conducting more than 20 clinical trials on 10 products and 8 combination treatment plans worldwide, covering all mainstream European and American biopharmaceutical markets and markets in many emerging countries.