HLB said Jiangsu Hengrui Pharmaceuticals have signed an agreement to grant global rights, excluding Korea and China, for camrelizumab, an immunotherapy candidate in development for the treatment of hepatocellular carcinoma (HCC), to Elevar, HLB's U.S. subsidiary.
HLB and Elevar now have global rights for both rivoceranib and camrelizumab, which is used as a combination treatment for HCC.
Under the agreement, Jiangsu Hengrui will receive up to $1 billion in cumulative royalties based on sales of camrelizumab for treating HCC for a decade following the start of commercialization of the drug.
The decision was based on the belief that it would be in Elevar's best interest to maximize revenues from the commercialization of the two drugs, which are expected to be prescribed together after approval for liver cancer in the U.S.
HLB expects the combination treatment to receive approval for treating HCC in the U.S. by the first half of next year.
"The combination of the two drugs, which demonstrated the longest survival in the history of liver cancer in a global phase 3 study, is a game-changer in the treatment of liver cancer patients," Elevar CEO Chong Sae-ho said. "The fact that the drugs are from different companies could have been a marketing disadvantage, but as a result of the recent agreement, commercialization will be faster and more efficient."
With the FDA's approval of the NDA filing on July 14, Elevar has already made significant progress in the commercialization process, with the company obtaining a pharmaceutical wholesaler license in 15 U.S. states.
The company expects that this will enable the joint marketing of both drugs to major cancer specialty hospitals in the U.S. and the establishment of a batch sales system.
"To gain a clear competitive advantage in the fiercely competitive liver cancer first-line treatment market, it is essential for one company to have the right to market both drugs," HLB Group Chairman Jin Yang-gon said. "We will make every effort to prepare for the final FDA approval and commercialization."
Related articles
- Promising results of HLB's HCC drug rivoceranib published in The Lancet
- FDA starts review of HLB's HCC drug rivoceranib
- HLB to be included in KRX300 Healthcare Index
- HLB submits NDA application for rivoceranib to FDA
- HLB to narrow down European partner candidates for ESMO meet
- [ESMO 2023] ‘HLB will apply for European authorization for rivoceranib this year’
- Rivoceranib+camrelizumab combo proves efficacy in lung cancer, too: HLB
- HLB shareholders pass its transfer listing to main bourse Kospi