HLB said it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for combination therapy of rivoceranib and camrelizumab as the first-line treatment for hepatocellular carcinoma (HCC).

HLB holds the global patent for rivoceranib.

Through its U.S. subsidiary Elevar Therapeutics, HLB has been developing the combination of rivoceranib and camrelizumab with Jiangsu Hengrui Pharmaceutical as a first-line treatment for liver cancer. The NDA submission comes after the two companies began their first global clinical trial of rivoceranib in 2011.

Rivoceranib is a Tyrosine Kinase Inhibitor (TKI)-class drug that works by inhibiting the vascular endothelial growth factor receptor 2 (VEGFR-2), which cuts off the supply of oxygen and nutrients essential for cancer growth.

The company submitted the NDA after completing its global phase 3 ARES 310 trial in 543 patients in 13 countries.

Results of the study showed that the rivoceranib and camrelizumab combination achieved three complete remission (CR) cases, a median overall survival (mOS) of 22.1 months, a median progression-free survival (mPFS) of 5.6 months, and an objective response rate (ORR) of 25.4 percent.

These figures were much higher than the control drug (sorafenib), which had one CR case, mOS of 15.2 months, mPFS of 3.7 months, and an ORR of 5.9 months.

"The combination of rivoceranib and camrelizumab shows clear promise as a potential treatment for HCC. I look forward to the FDA completing the review soon," said Ahmed Omar Kaseb, a University of Texas MD Anderson Cancer Center professor.

Elevar plans to rapidly prepare for U.S. commercialization to ensure quick sales following approval.