• Combination therapy has potential to offer a new treatment option for patients with advanced hepatocellular carcinoma, a condition with an urgent medical need
• Hengrui is evaluating commercialization opportunities in markets outside of China

Shanghai, China – May 13, 2022 – Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) today announced that the global phase 3 SHR-1210-III-310 trial evaluating camrelizumab with rivoceranib, a tyrosine kinase inhibitor (TKI), versus sorafenib met the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in previously untreated patients with advanced hepatocellular carcinoma (HCC). This is the first phase 3 study to demonstrate significant PFS and OS benefits with the combination of an anti-PD-1 antibody and an orally administered small-molecule anti-angiogenic drug over sorafenib as a first-line treatment for advanced HCC. Based on this study, camrelizumab was granted orphan drug designation by US FDA for the treatment of advanced HCC.

“We and others have established the validity of immune-checkpoint inhibition for the treatment of HCC and this combination therapy has the potential of offering patients a new treatment option in the first line setting,” said Dr. Lianshan Zhang, president of global R&D, board director of Hengrui Pharma. “We continue to work to bring this combination therapy to HCC patients who are in need.”

Hengrui Pharma submitted a new indication application to the National Medical Products Administration (NMPA) of China in December 2021 based on the primary analysis of the progression-free survival. Hengrui Pharma plans to discuss the trial results and next steps for a regulatory filing with the U.S. Food and Drug Administration (FDA). Top-line findings from the SHR-1210-III-310 study will be presented at an upcoming international medical meeting.

About SHR-1210-III-310 Trial

The SHR-1210-III-310 study (ClinicalTrials.gov, NCT03764293) is a randomized, open-label, phase 3 trial conducted in 95 study sites across 13 countries/regions to investigate the efficacy and safety of camrelizumab plus rivoceranib versus sorafenib as first-line therapy in patients with incurable, locally advanced or metastatic HCC who had not received previous systematic treatment. The primary endpoints were overall survival and progression-free survival as assessed by the blinded independent review committee according to Response Evaluation Criteria in Solid Tumors version 1.1. A total of 543 patients were randomized 1:1 to receive camrelizumab (200 mg intravenously once every two weeks) plus rivoceranib (250 mg orally once daily) or sorafenib (400 mg orally twice daily).

About Camrelizumab 

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 36 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.

Camrelizumab, under the brand name AiRuiKa®, is currently approved for 8 indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. FDA granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021. In April 2020, Hengrui Pharma licensed the Korean rights of camrelizumab to CrystalGenomics Inc., a biotech company based in the Republic of Korea.

About Rivoceranib (Apatinib)

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) approved for gastric cancer, under the name apatinib and the brand name Aitan®, in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in multiple tumor types including gastric cancer, hepatocellular carcinoma, and colorectal cancer.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 24th among the top 1,000 global pharma companies in 2021¹. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the fourth consecutive year, rising from the 47th in 2019 to the 32nd in 2022².

1.  https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf.

2.  https://www.pharmexec.com/view/2022-pharm-exec-top-50-companies

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