HLB Submits Liver Cancer Drug Approval Application to US FDA

HLB has completed all preparations for the new drug approval of the targeted anticancer drug ‘Rivoceranib,’ which is being developed as a first-line treatment for liver cancer.

On the 16th (U.S. time), HLB submitted a New Drug Application (NDA) to the U.S. FDA. It has entered the NDA stage about 12 years after starting the first global clinical trial for Rivoceranib in 2011. This is the first time a Korean 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.

HLB, which holds the global patent rights for Rivoceranib, developed the combination therapy of Rivoceranib and the immune checkpoint inhibitor ‘Camrelizumab’ (held by Hansoh Pharmaceutical) as a first-line treatment for liver cancer through its U.S. subsidiary Elevar Therapeutics.

Results from the global Phase 3 clinical trial (CARES 310), conducted on 543 patients across 13 countries, demonstrated higher therapeutic efficacy compared to the control group, Sorafenib.

The hazard ratio was 0.62 for overall survival and 0.52 for progression-free survival, indicating a 40-50% reduction in the risk of patient death, which was analyzed as an encouraging result. The FDA held a pre-NDA meeting before the new drug application and stated that there were "no issues" with the NDA submission for the Rivoceranib combination therapy. In China, where the application was submitted, it was already approved as a first-line treatment for liver cancer in February.

Professor Ahmed Omar Kaseb of the University of Texas MD Anderson Cancer Center said regarding the NDA submission, "The combination therapy of Rivoceranib and Camrelizumab shows clear potential as a promising treatment for hepatocellular carcinoma." He added, "I look forward to the FDA completing its review as soon as possible."

Jung Se-ho, CEO of Elevar, also said, "With the NDA submission, HLB has set an important milestone in its efforts to provide better treatment options for liver cancer patients worldwide," and expressed expectations that "the new drug approval will be granted as the clinical results have received positive evaluations from many clinicians."

Rivoceranib is an oral TKI drug that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), blocking the supply of oxygen and nutrients essential for tumor growth, effectively killing cancer. The fact that there is currently no approved first-line treatment for liver cancer combining TKI anticancer drugs with anti-angiogenic mechanisms and immuno-oncology drugs further raises expectations for the approval of these two drugs. Elevar has already begun preparations for commercialization in the U.S. to enable rapid sales after approval, anticipating the post-approval phase. This is a ‘two-track’ strategy to simultaneously proceed with new drug approval and commercialization.

Kim Dong-gun, CEO of HLB, said, "We will do our best in the remaining procedures so that liver cancer patients and their families, who are eagerly waiting for new treatment options, as well as employees and shareholders who have been with us throughout the 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, Hansoh Pharmaceutical holding the Chinese distribution rights, and Elevar holding the global distribution rights for other regions.