HLB’s anticancer drug wins approval in China

HLB’s anticancer drug Rivoceranib was approved to be used for first-line treatment for liver cancer in China, the Korean biotech company said Thursday.

The company said China’s National Medical Products Administration (NMPA) approved the combination therapy of Rivoceranib and Camrelizumab, an anticancer drug of China’s Jiangsu Hengrui Medicine, as a first-line treatment for liver cancer on Jan. 31.

It has been about three years and nine months since the company launched the Phase 3 global clinical trials of Rivoceranib in April 2019.

“As Rivoceranib was officially approved as the first-line treatment for liver cancer in China, we expect there will be good signals on the new drug applications (NDAs), which HLB is scheduled to proceed in the United States, Europe and Asia,” a company spokesman said.

“The company already received an answer from the U.S. Food and Drug Administration (U.S. FDA) that there is ‘no problem’ with the Rivoceranib-included combination’s NDA process through preNDA before applying for a new drug license,” he added.

According to the result of Phase 3 clinical trials over a large number of patients, the median overall survival (MOS) period of the entire patient base was 22.1 months, which was higher than a comparative treatment, which showed a MOS of 15.2 months.

HLB expects the Rivoceranib combination therapy can be a new option for patients with high drug efficacy and safety. Also, the combination has a price advantage compared to other drugs.

The company is the only Korean company that is directly conducting NDAs for anticancer drugs without selling its technologies. Given that it takes a long time and an enormous amount of money to launch a new anticancer drug, such a strategy is possible only with high trust in new drug substances and developers, HLB said.