Shanghai Henlius Biotech, Inc., received the approval to conduct clinical trial for its recombinant fully human monoclonal antibody against Vascular Endothelial Growth Factor Receptor-2 (HLX12; hereinafter referred to as the New Drug) from the National Medical Products Administration (NMPA) for the treatment of advanced gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).
According to the reports, the anti-VEGFR2 monoclonal antibody (mAb) is an effective treatment for advanced tumors. As of today, the only approved anti-VEGFR2 monoclonal antibody is ramucirumab, which is not available in China (excluding Hong Kong, Macao and Taiwan).
Ramucirumab is a VEGFR2 antagonist that specifically binds to VEGFR2 and blocks the binding of vascular endothelial growth factor (VEGF) ligands. VEGFR2 is known to mediate a complex cascade of the downstream VEGF signaling pathways resulting in angiogenesis. VEGF blockade inhibits these signaling pathways and thereby effects the tumor survival, migration and invasion. As a biosimilar of ramucirumab, HLX12 is expected to potentially increase market competition and treatment accessibility of anti-VEGFR2 antibody.
Henlius actively implements the product development strategy and has established a mature pipeline of biosimiliar, biobetter and bio-novel. The first four leading candidates under the biosimilar pipeline is currently in Phase 3 clinical stage, with additional products currently being investigated at the pre-clinical and early clinical stage phases. Concurrently, Henlius is also developing HLX06, a Recombinant Fully Human Anti-VEGFR2 Monoclonal Antibody Injection. In June and September 2018, HLX06 was approved for clinical trials from mainland China and the United States, respectively, becoming the second bio-novel has been given clinical trial approvals in three locations (mainland China, Taiwan China and the United States) after HLX07. In addition, Henlius is dedicated in the area of “combo-immunotherapy” and becomes one of the few companies developing both anti-PD-1 and anti-PD-L1 mAb in China. As of today, HLX10 (anti-PD-1) and HLX20 (anti-PD-L1) have been given clinical trial approvals from multiple locations around the world, and phase 1 clinical trial was successfully conducted in Taiwan and Australia, respectively.
Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in December 2009, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, biobetter and bio-novel monoclonal antibody, to treat tumor and autoimmune diseases.
As of today, Henlius has completed IND/CTA filings of 12 products and 1 combination immuno-oncology therapy with 20 indications and obtained 27 successful IND/CTA fillings (17 approvals from mainland China; 3 from Taiwan; 3 from United States, and 1 each from the European Union, Ukraine, the Philippines and Australia).
Henlius has submitted its first New Drug Application (NDA) of its HLX01 (MabThera®/Rituxan® biosimilar), rituximab developed by Henlius, to National Medical Products Administration (formerly CFDA), which soon assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China.