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| Jang Seong-hoon, chief operating officer of Elevar Therapeutics, HLB's U.S. subsidiary, explains the efficacy and safety of the company's Rivoceranib anticancer drug during a symposium hosted by Korea's Ministry of Food and Drug Safety in Washington, D.C., March 21. HLB said on Thursday it recently submitted a new drug application to the U.S. FDA for Rivoceranib. Courtesy of HLB |
By Baek Byung-yeul
HLB, an international biopharmaceutical company, submitted a new drug application (NDA) for its Rivoceranib liver cancer drug to the U.S. Food and Drug Administration (FDA) on Tuesday. If successful, it would become the first Korean biotechnology company to win a new drug approval in the U.S., the company said Thursday.
It has taken the company about 12 years to get to this point since first launching a global trial of Rivoceranib in 2011.
"This is the first time a Korean biopharmaceutical company has completed its own clinical trials for a new anticancer drug and proceeded with the NDA process," a company spokesman said.
HLB, which holds global patent rights for Rivoceranib, has been developing a combination therapy of Rivoceranib and Camrelizumab, an anticancer drug of China's Jiangsu Hengrui Medicine, as a first-line treatment for liver cancer through its U.S. subsidiary Elevar Therapeutics.
HLB completed the global Phase 3 clinical trial of the anticancer treatment in May 2022. The Phase 3 trial for liver cancer treatment, which began in April 2019, was conducted on 543 patients in 13 countries including Korea, the U.S. and China. The results of the clinical trial using the combination therapy showed the two treatments succeeded to meet primary endpoints, which means that both the efficacy and versatility have been proven.
Particularly, the clinical trial showed a reduction of between 40 percent and 50 percent in the risk of patient death. Based on these results, the FDA indicated that it has "no concerns" with the submission of an NDA for a Rivoceranib-included combination after a pre-NDA meeting. The combination was already approved in China in February as a first-line treatment for liver cancer.
HLB said Dr. Ahmed Omar Kaseb, a professor at the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at the University of Texas, commented on the NDA application for Ricoveranib, stating that "the combination therapy shows clear promise as a potential treatment for hepatocellular carcinoma."
Jin Yang-gon, chairman of HLB Group, wrote on the company's website that he was grateful to employees and shareholders who had endured a very long and tough time before filing the NDA.
"Despite all the criticism and ridicule, we have come this far thanks to the solid efforts of our employees. On behalf of our leaders, I would like to express our deepest gratitude to you," the chairman wrote. "I would also like to express my gratitude to shareholders for your unwavering support. Whenever we sigh and shed tears, you were the first to reach out to us and encourage us."
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