In May, Hengrui Pharma and Elevar submitted a BLA and NDA for the combination of camrelizumab and rivoceranib as a first-line therapy for uHCC, with FDA PDUFA dates in May 2024 FORT LEE, N.J. and PRINCETON, N.J., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), one of China’s largest pharmaceutical companies based on market cap and innovation index1 with 14 research and development centers worldwide, and Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and fully integrated biopharmaceutical company, today announced a global licensing agreement that grants Elevar rights to commercialize and develop Hengrui Pharma’s anti-PD-1 antibody camrelizumab in combination with rivoceranib (also known as apatinib) for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea. Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales. Rivoceranib, under the name apatinib (brand name: Aitan®), is developed by Hengrui Pharma in China. In January 2023, the combination was approved in China as a first-line treatment for uHCC. Elevar maintains development rights to rivoceranib outside of China and Korea. Hengrui Pharma has 13 in-house-developed innovative products and two in-licensed innovative products marketed in China, more than 80 proprietary innovative candidates in the R&D stage and nearly 20 under clinical development worldwide. The company has also demonstrated a clear commitment to HCC patients globally, as its initial efforts in China led to the 2020 approval of apatinib as a single agent for second-line treatment for advanced HCC. Elevar and Hengrui Pharma presented CARES-310 study results at the September 2022 ESMO Congress and published them in The Lancet on July 24, 2023. Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.
Hengrui Pharma 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 Pharma ranked 24th among the top 1,000 global pharma companies by the Torreya in 2021. Hengrui Pharma has been on the Pharma Exec’s annual listing of the top 50 global pharmaceutical companies for the fifth consecutive year.
Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidate is rivoceranib. Additional information is available at ElevarTherapeutics.com.
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