Fully leveraging the global research and development platform, we have developed a diversified and advanced pipeline, covering more than 20 biosimilars, and bio-innovative candidates, with significant potential for a variety of PD-1/PD-L1 based immuno-oncology combination therapies. Our R&D platform spans our three R&D facilities located in Shanghai, Taipei and California to ensure the highly productive and cost-efficient R&D processes through close collaboration. We had also assembled a team of over 200 well-trained R&D employees, a large number of whom possess a Ph.D or equivalent degree and have extensive working experience in global large pharmaceutical companies.
We have established a quality management system that covers the entire product lifecycle in accordance with the quality standard of the United States, EU and China. We have a team of over 120 employees who support quality assurance and quality control. With a manufacturing facility established since 2016, we have passed multiple on-site inspections conducted by EU QP. The facility is in compliance with the current Good Manufacturing Practices (cGMP) standards. Particularly, the first product – HLX01 (汉利康®, Rituximab Injection) was awarded the Certificate of Good Manufacturing Practices for Pharmaceutical Products, People’s Republic of China. We are also a pioneer in adopting single-use bioreactors in China. Single-use bioreactors are estimated to generally reduce capital expenditure by up to 50% and production costs by up to 25% to 30%, which distinguishes us with commercial-scale manufacturing capabilities featuring cost advantage and overall quality management.
We have formed a professional commercial team with rich industry experience. With the successful launch of 汉利康® (Rituximab Injection), we will further polish the business planning, build product marketing strategy and assemble a professional and efficient team. Meanwhile, we have entered into license and commercialisation agreements with multiple partners, including Fosun Pharma, Accord Healthcare, Cipla, Biosidus, Jacobson Medical and KG Bio to reach more markets in different regions and to fulfill the mission of “bringing more effective biologics to more patients globally.”