HLB, a Korean biotech firm, said Tuesday it would submit a new drug application (NDA) to the FDA for marketing approval of an anticancer drug, rivoceranib, in early 2023.

HLB said the FDA’s designation of camrelizumab, used in combination with rivoceranib, as an orphan drug would speed up the regulator’s review of rivoceranib.

Also on Tuesday, HLB said its phase 3 study of rivoceranib plus camrelizumab as the first-line treatment in hepatocellular carcinoma (HCC) was selected as one of the ESMO 2022 Gastrointestinal Cancer Congress Highlights.

According to HLB, a group of experts picks Congress Highlights that showed remarkable research outcomes or suggested a new treatment option in each field on the last day of the ESMO annual meeting.

“The clinical results of rivoceranib were presented at the world’s two most prestigious cancer meets, ASCO and ESMO, and selected as ESMO Congress Highlights,” an official at HLB said.

“So, rivocernaib has become a new anticancer drug drawing the most attention not only from the industry but from academia.”

Rivoceranib also proved its high versatility with other anticancer drugs including immunotherapy, which will prompt extensive collaborations between HLB and multinational pharmaceutical companies, he added.