HLB Riboceranib, Camrelizumab Combination Approved for Liver Cancer Treatment in China

HLB logo [Photo by HLB]

[Asia Economy Reporter Chunhee Lee] HLB's anticancer new drug 'Rivoceranib' and Antengene's immuno-oncology drug 'Camrelizumab' combination therapy for liver cancer has been approved as a first-line treatment drug in China.

According to HLB on the 1st, the China National Medical Products Administration (NMPA) approved the Rivoceranib-Camrelizumab combination therapy as a first-line treatment for liver cancer the day before. It has been about 3 years and 9 months since the global Phase 3 clinical trial began in April 2019.

Following the demonstration of bioequivalence of Rivoceranib in January, and its official approval as a first-line treatment for liver cancer in China, momentum is expected to build for new drug applications (NDA) planned in the United States, Europe, and various Asian countries. The U.S. Food and Drug Administration (FDA) has already stated in pre-NDA consultations that there are no issues with proceeding with the NDA for the Rivoceranib combination.

The combination therapy of the two drugs is the first combination of an anti-angiogenic inhibitor (VEGF TKI) and an immune checkpoint inhibitor (PD-1 inhibitor), attracting significant attention from the academic community. In the Phase 3 clinical trial, the median overall survival (mOS) of all patients was 22.1 months, significantly longer than the control group’s 15.2 months with sorafenib. The median progression-free survival (mPFS) was also higher at 5.6 months compared to 3.7 months in the control group. Objective response rate (ORR) was 25.4% versus 5.9%, disease control rate (DCR) 78.3% versus 53.9%, and duration of response (DoR) 14.8 months versus 9.2 months, showing superior efficacy over the control group across various indicators. All these figures met statistical significance (P<0.0001).

Notably, high efficacy was confirmed not only in patients infected with hepatitis B virus but also in those with hepatitis C virus infection, which is the main cause of liver cancer in Western populations, as well as in non-viral patients, indicating broad therapeutic effects regardless of region or cause of onset.

HLB plans to promptly obtain FDA approval in the U.S. while simultaneously establishing strategies for direct sales in the U.S. and technology licensing by country in Europe and Asia. If new drug approval becomes visible in the U.S. following China, it is expected to secure a much more advantageous position in technology licensing negotiations.

Yonghae Han, Chief Technology Officer (CTO) of HLB Group Bio, said, “This new drug approval in China marks the first signal for the birth of a new blockbuster drug in the field of first-line liver cancer treatment,” and added, “We will devote all efforts to the upcoming U.S. NDA process to achieve good results this year.”