HLB gains US momentum as FDA clears subsidiary’s bile-duct drug, easing liver-cancer setbacks

The US Food and Drug Administration approved Lyrfigtu, developed by Elevar Therapeutics, HLB’s American subsidiary, for patients with previously treated advanced bile-duct cancer harboring FGFR2 fusions or rearrangements. This marks HLB’s first FDA approval and gives the company direct insight into the agency’s review process as it readies a new drug-application for rivoceranib, an oral targeted agent being tested with Jiangsu Hengrui Pharmaceuticals’ immunotherapy camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

Although a global phase-3 trial showed a median overall survival of 23.8 months, the FDA has rejected rivoceranib three times, most recently citing manufacturing deficiencies. In July, the FDA assigned a Voluntary Action Indicated status to both the active-ingredient and finished-drug facilities of Hengrui, indicating issues that require corrective action but not formal enforcement, thereby reducing regulatory uncertainty.

HLB’s stock, which had fallen 30% after each prior rejection, surged 30% after the Lyrfigtu approval was announced. Company chairman Jin Yang-gon hailed the milestone as a turning point for HLB’s global expansion and a foundation for future drug successes.