The combination use of Jiangsu Hengrui Medicine’s camrelizumab and HLB Bio’s rivoceranib has received a novel drug approval from the National Medical Products Administration of China, HLB Bio announced Wednesday.
With the approval, the camrelizumab-rivoceranib combination can be used as the first-line treatment for patients with unresectable hepatocellular carcinoma in China.
The approval was given three years and nine months after the company started its phase 3 clinical trial April 2019.
The recent approval from China's drug regulator is expected to help the company in dealing with a new drug application for the US Food and Drug Administration’s approval.
“The latest approval of rivoceranib as the first-line treatment in China is a good sign for the company. HLB Bio will soon push ahead with the NDA process in the US and technology transfer deals in overseas countries,” an official from HLB Bio said.
According to the official, HLB is ramping up efforts for the NDA process in the US. Exactly when the company will submit the application, however, cannot be disclosed at the moment, the official added.
While preparing for the NDA process with the US Food and Drug Administration, HLB Bio is currently seeking options for technology transfer deals in Europe and Asia.
The company’s official said actual deals could be made after the company receives the greenlight for the treatment in the US.
The company expects its own low-cost cancer treatment could reduce the total cost of care for patients while maintaining the same quality of care.
An industry source said the camrelizumab-rivoceranib combination could be significantly cheaper than the Avastin-Tecentriq combination, the most commonly used treatment in the US. The Avastin-Tecentriq combination is known to cost roughly $320,000 per patient a year.
The combination use of camrelizumab and rivoceranib has also proven its efficacy during its phase 3 clinical trial, HLB Bio said. The clinical data showed that the new combination significantly improved both progression-free survival, PFS, and overall survival, OS, compared with sorafenib, sold under the brand name Nexavar, for patients with unresectable hepatocellular carcinoma.
The median OS, with the camrelizumab-rivoceranib treatment was 22.1 months, compared with 15.2 months with sorafenib. The median PFS, with camrelizumab-rivoceranib treatment was 5.6 months, compared with 3.7 months for sorafenib.
The median OS is a measure of how long someone lives after starting on a treatment, while the median PFS is a measure of how long someone is on a treatment before their cancer starts to grow.