Supported by our strong talent base and our fully integrated R&D platform, we have developed, and continued to expand a comprehensive product pipeline of multiple late-stage biologics candidates and bio-innovative drugs, with significant potential for a variety of PD-1/PD-L1 based immuno-oncology combination therapies.
Until now, we have completed IND/CTA filings of 13 products and 2 combination therapies with 23 indications and obtained 29 successful IND/CTA approvals (19 approvals from mainland China; 3 from the United States; 3 from Taiwan, China; each 1 from the European Union, Ukraine, Philippines and Australia). HLX01 (rituximab injection), our first product, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 has received a New Drug Application (NDA) acceptance from NMPA.