Fully leveraging the global research and development platform, we have been exploring pipeline opportunities for more than 20 innovative mAb candidates, with significant potential for a variety of PD-1-based immuno-oncology combination therapies, focusing on the therapeutic areas of oncology, autoimmune diseases and ophthalmic diseases. We keep the momentum for a diversified innovation by enhancing internal innovation capacities and reaching out to more strategic partners. The global innovation center is responsible for late-stage development and early-stage development to ensure the highly productive and cost-efficient R&D processes.
Henlius has 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Southeast Asia, Europe, and Latin America. Henlius has established a quality management system in accordance with the highest quality standards. The system covers the entire product life cycle from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. Its fully operational manufacturing sites and supporting quality management systems have passed on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person, as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and the U.S. regulatory agencies as well as various PIC/S participating members.
We have built an in-house commercial team focused on domestic market. The team is responsible for the commercialisation of our core oncology products including HANQUYOU (trastuzumab), HANBEITAI (bevacizumab injection), HANSIZHUANG (serplulimab) etc. We have built an in-house commercial team focused on domestic market, covering marketing, access, channel, pricing, strategy and sales and compromising of about 1500 professionals; we have also joined forces with global partners, expanding our reach in major markets as well as emerging markets worldwide.
