HLB (028300) extended its rally for a second day after the U.S. Food and Drug Administration approved its new bile duct cancer drug. Expectations that the company will expand its business as it prepares to sell the drug in the United States are being reflected in the share price.
HLB traded at 43,100 won as of 9:17 a.m. on the 29th, up 3,400 won or 8.56% from the previous session, according to the Korea Exchange. The stock closed at 39,700 won on the 28th after rising to its daily limit.
Other HLB group affiliates also advanced, with HLB Global (003580) up 5.35%, HLB Biostep (278650) up 15.38%, HLB Life Science (067630) up 13.66%, HLB Pharmaceutical (047920) up 22.25% and HLB Therapeutics (115450) up 2.71%.
The rally stems directly from the FDA's approval of Lypictu (lirafugratinib), a bile duct cancer treatment developed by Elevar Therapeutics, HLB's U.S. subsidiary. Lypictu was approved as a second-line treatment for patients with locally advanced or metastatic bile duct cancer with confirmed FGFR2 gene fusions or rearrangements.
The approval is notable because HLB licensed a drug candidate developed overseas and then pursued U.S. approval and commercialization on its own. Elevar secured global development and commercialization rights to Lypictu from U.S.-based Relay Therapeutics in December 2024, then led the approval filing and the response to the FDA review. Lypictu had already completed Phase 1 and 2 trials at the time, making it a case in which HLB brought in a late-stage asset and carried it to FDA approval in a relatively short period.
In the Phase 1 and 2 trials that formed the basis for approval, tumors shrank in 45.7% of patients, and about half of those who responded maintained the treatment effect for 11.8 months or longer. The oral cancer drug selectively inhibits FGFR2 and is characterized by greater target selectivity than existing FGFR inhibitors.
HLB is targeting a U.S. launch in the fourth quarter. About 8,000 people are diagnosed with bile duct cancer in the United States each year, so the market itself is not large, but as a targeted therapy for patients with FGFR2 gene fusions or rearrangements, the drug can pursue a specific patient group. Existing FGFR-targeted therapies are already on the market, however, so actual sales will depend on Lypictu's competitiveness and whether prescriptions expand.
Investors are watching whether the approval will affect HLB's other drug development efforts. Rivoceranib, HLB's flagship candidate for liver cancer, is being prepared for resubmission after receiving three complete response letters (CRLs) from the FDA. HLB said it has completed work on chemistry, manufacturing and controls (CMC) issues and plans to resubmit after securing additional safety data.
With the Lypictu approval giving HLB experience in navigating the approval process with U.S. regulators, another question is whether the company can apply that experience to the Rivoceranib resubmission. Still, because the two drugs followed different development and approval paths, it is difficult to conclude that the approval itself improves Rivoceranib's chances of clearance.
