HLB Completes New Drug Application for 'Rivoceranib' for Liver Cancer with US FDA

Camrelizumab Combination Therapy
First NDA for Domestic Bio as a Global Anticancer Agent

HLB announced on the 17th that it has completed the new drug approval preparation process for the targeted anticancer drug 'Rivoceranib,' which is being developed as a first-line treatment for liver cancer, and has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).

HLB logo. [Image provided by HLB]

With this, HLB has finally entered the NDA stage about 12 years after starting global clinical trials for Rivoceranib in 2011. HLB explained that this is the first time a domestic bio company has independently completed all clinical trials for its anticancer new drug substance and proceeded with the new drug approval process in the global market.

Rivoceranib is an oral tyrosine kinase inhibitor (TKI) that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), blocking the supply of oxygen and nutrients essential for tumor growth, thereby inducing cancer cell death. HLB’s U.S. subsidiary, Elevar, is preparing for commercialization in the U.S. to enable rapid sales after drug approval, adopting a 'two-track' strategy that simultaneously advances drug approval and commercialization.

HLB, which holds the global patent rights for Rivoceranib, has been developing a combination therapy of Rivoceranib and the immune checkpoint inhibitor 'Camrelizumab' (licensed by Hansoh Pharmaceutical) as a first-line treatment for liver cancer through Elevar.

In a Phase 3 clinical trial conducted on 543 patients across 13 countries, the median overall survival (mOS) was 22.1 months, approximately 7 months longer than the 15.2 months observed in the control group treated with Sorafenib. The median progression-free survival (mPFS) was also longer at 5.6 months compared to 3.7 months for Sorafenib. The objective response rate (ORR) was 25.4%, significantly higher than Sorafenib’s 5.9%.

Professor Ahmed Omar Kaseb of the University of Texas MD Anderson Cancer Center commented on the NDA submission, stating, "The combination therapy of Rivoceranib and Camrelizumab shows clear potential as a promising treatment for hepatocellular carcinoma. As a specialist deeply interested in advancing standard treatments for liver cancer patients, I am very pleased with the NDA submission and look forward to the FDA’s prompt review."

HLB CEO Dong-geon Kim said, "We will do our best in the remaining procedures so that liver cancer patients and their families, who are eagerly awaiting new treatment options, as well as our employees and shareholders who have been part of this long new drug development journey, can feel great comfort and pride."

HLB holds the global patent rights for Rivoceranib, with HLB Life Science holding the Korean distribution rights and partial revenue rights for Europe and Japan, and Hansoh Pharmaceutical holding the Chinese distribution rights. Elevar holds the global distribution rights for other regions.

This content was produced with the assistance of AI translation services.