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 two R&D facilities, located in Shanghai and California, are respectively responsible for late-stage development and early-stage development, to ensure the highly productive and cost-efficient R&D processes through close collaboration.
We have established a quality management system that covers the entire product lifecycle in accordance with the quality standards of the US, the EU and China. Xuhui Manufacturing Facility, established since 2016 with commercial capacity of 20,000L, is granted GMP certification from China and the EU. We have also completed the construction of 24,000L production capacity in Songjiang Manufacturing Facility (First Plant). Meanwhile, the construction of Songjiang Manufacturing Facility (Second Plant) Phase 1 project, with 36,000L in plan, is also commenced. The structure of production buildings has been completed and main structure inspected. The cutting-edge technologies such as single-use production technology and continuous manufacturing technology are adopted for higher production efficiency and lower manufacturing cost. The first batch of non-GMP production for downstream continuous manufacturing of a single project is completed in Songjiang Manufacturing Facility (First Plant).
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 汉曲优® (trastuzumab), HLX04 (bevacizumab injection), Serplulimab (anti-PD-1 mAb) 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 450 professionals; we have also joined forces with oversea partners, expanding our reach in major markets as well as emerging markets worldwide.