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| Jang Seong-hoon, chief operating officer of Elevar Therapeutics, explains the efficacy and safety of Rivoceranib during a symposium hosted by the Ministry of Food and Drug Safety and the Korea American Society in Biotech and Pharmaceuticals, in Washington, D.C., Tuesday (local time). Courtesy of HLB |
By Baek Byung-yeul
HLB, a global biopharmaceuticals company, said Thursday that its U.S. subsidiary Elevar Therapeutics announced the efficacy and safety of the Rivoceranib liver cancer drug at a biopharmaceutical symposium in Washington, D.C. This comes as part of the Korean biotech company's efforts to promote the drug ahead of applying for new drug application (NDA) with the U.S. Food and Drug Administration.
Executives of Elevar participated in the symposium, Tuesday, co-hosted by Korea's Ministry of Food and Drug Safety and the Korea American Society in Biotech and Pharmaceuticals (KASBP). The event featured Oh Yu-kyoung, minister of food and drug safety, and Seungwon Chung, president of the KASBP.
Rivoceranib is a cancer drug that holds global patents by HLB. HLB Life Science, a subsidiary of HLB, has distribution rights for the drug in Korea and partial revenue rights for Europe and Japan. Global distribution rights for other regions are owned by Elevar.
HLB completed the global Phase 3 clinical trial of the anticancer treatment in May 2022. The Phase 3 trials for liver cancer treatment, which began in April 2019, were conducted on 543 patients in 13 countries including Korea, the U.S. and China. The test result of the clinical trial that used both Rivoceranib and Camrelizumab, a drug of China's Jiangsu Hengrui Medicine, showed the two treatments succeeded to meet primary endpoints, which means that both the efficacy and versatility have been proven.
With the completion of the Phase 3 test, HLB is set to apply for the NDA with the U.S. FDA in May. "We are preparing document packages to demonstrate the efficacy and safety of Rivoceranib to the U.S. FDA. Since the clinical trial was jointly conducted with Camrelizumab, we have formed a joint team with Jiangsu Hengrui Medicine for the NDA," an HLB spokesman said.
Also, HLB Life Science applied for a conditional product license application for adenoid cystic carcinoma cancer to the Ministry of Food and Drug Safety in February.
"The clinical trial showed that the MOS (median overall survival) period of the entire patient base was 22.1 months," Jang Seong-hoon, chief operating officer of Elevar Therapeutics, said during the symposium. "We expect this drug to be a best-in-class liver cancer treatment when it obtains new drug permits from countries such as the U.S."
The KASBP is a non-profit organization established in 2001 to promote academic cooperation and networking among members.
"The KASBP was established to support new drug research and development in collaboration with Korean experts based in the U.S. and the Korean government-supported institutions, helping biotech companies and researchers to effectively exchange information about new drug development in the U.S.," Han Yong-hae, CEO of HLB Life Science and former president of the KASBP, said.
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