Wednesday, October 18, 2023
Elevar Therapeutics, Inc., a biopharmaceutical company majority-owned by HLB Co., Ltd., has entered into a global licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), one of China's leading pharmaceutical companies. This agreement grants Elevar the rights to develop and commercialize Hengrui Pharma's anti-PD-1 antibody, camrelizumab, in combination with rivoceranib for the treatment of unresectable hepatocellular carcinoma (uHCC) worldwide, excluding the Greater China Region and Korea.
Under the terms of the agreement, Elevar will make payments to Hengrui Pharma based on sales milestones and will pay a royalty on net sales of camrelizumab. The total potential payout over a 10-year period could reach a significant sum.
In May 2023, an application for new drug approval (NDA) for rivoceranib and a biologics license application (BLA) for camrelizumab were submitted to the U.S. Food and Drug Administration (FDA) for their use in combination as a first-line therapy for uHCC. The FDA accepted the submissions and set Prescription Drug User Fee Act (PDUFA) target action dates for May 2024.
It's worth noting that Rivoceranib was developed by Hengrui Pharma in China and received approval in China as a first-line treatment for uHCC in January 2023. Elevar retains the development rights for rivoceranib outside of China and Korea.
Saeho Chong, CEO of Elevar, expressed optimism about the collaboration, highlighting the potential to advance the standard of care for uHCC by combining camrelizumab and rivoceranib under one portfolio. He emphasized the promising results from their investigational Phase 3 CARES-310 study, which demonstrated improved overall survival compared to existing treatments for uHCC.
Hepatocellular Carcinoma (HCC) is the most prevalent form of liver cancer, and it is associated with limited treatment options and a poor prognosis. Each year, it leads to over 830,000 deaths worldwide.
Hengrui Pharma, a global pharmaceutical player with research and development centers worldwide and a strong commitment to innovation, has been dedicated to addressing the needs of HCC patients. They achieved approval for rivoceranib as a second-line treatment for advanced HCC in China in 2020.
Elevar and Hengrui Pharma initially presented the results of the CARES-310 study in September 2022 and later published the results in The Lancet in July 2023. These findings demonstrated that the combination of camrelizumab and rivoceranib led to significant improvements in overall survival, progression-free survival, and overall response rates compared to the standard first-line treatment for uHCC, sorafenib.
Camrelizumab is a monoclonal antibody targeting the programmed death-1 (PD-1) receptor, with successful applications in various cancer types, including liver cancer. Rivoceranib is a tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor 2 (VEGFR-2), a key pathway for tumor angiogenesis.
This collaboration between Elevar and Hengrui Pharma aims to address the urgent medical need for effective treatments for HCC patients and improve their treatment options.