Researchers from HLB Group work in a lab. Courtesy of HLB

By Baek Byung-yeul

Local biotech company HLB is stepping up efforts to win a novel drug approval in the United States for its liver cancer treatment Rivoceranib, after completing a pre-new drug application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company said Wednesday.

HLB's U.S. subsidiary Elevar Therapeutics and China's Jiangsu Hengrui Medicine completed the pre-NDA meeting with the FDA on Oct. 11. During the meeting, the FDA reviewed the results of Phase 3 liver cancer clinical trials involving a combination of Rivoceranib and Camrelizumab.

A pre-NDA meeting is held to discuss in advance the data and content of applications for new drug permits from the FDA before starting the actual NDA process.

"We plan to proceed with the NDA soon because the FDA didn't raise any objections to the data presented by Elevar during the pre-NDA meeting," an HLB spokesman said.

To commercialize the drug, HLB conducted Phase 3 trials on 543 patients in 13 countries. The Phase 3 clinical trials succeeded in producing positive results as Rivoceranib showed over 22 months of overall survival, the longest of any liver cancer treatment, the company said.

"We feel very encouraged as the FDA positively evaluated the NDA process without a request for supplementation of the submitted data," Elevar Therapeutics CEO Chong Sae-ho said.

"We are confident that Rivoceranib will cruise through the new drug licensing process as the drug has proven its high efficacy as a liver cancer treatment in many countries, including the U.S. and countries in Europe and Asia, regardless of the cause of cancer."

The test results were announced last month at this year's European Society for Medical Oncology (ESMO) Congress in Paris and the treatment was praised by experts, HLB said.