HLB (028300) Group is seeking U.S. approval this year for its liver cancer treatment, a combination of rivoceranib and camrelizumab, after winning U.S. marketing approval for a bile duct cancer drug earlier this year. The group resubmitted the new drug application to the U.S. Food and Drug Administration in early October, and a decision could come as soon as this year depending on how the agency classifies the review.
HLB Group held its 2026 Integrated IR Day on the 15th in Seoul's Yeouido district, where it outlined the business status and future plans of its main affiliates. Kim Tae-han, chairman overseeing HLB Group's bio division, said: "We resubmitted the liver cancer drug application in early October, and the FDA's review classification will be determined within a month." He added, "There is a strong chance it will be classified as Class 1, so we expect a decision on approval as early as this year."
When a new drug application is resubmitted, the FDA designates the review as either Class 1 or Class 2 depending on the scope of the supplementary data to be examined. A Class 1 review, which covers relatively minor supplementary items, takes about two months, while a Class 2 review, which requires a broader examination, takes six months. If HLB's liver cancer drug is designated Class 1, a decision could come in early December, based on the October 9 resubmission date.
Approval of the liver cancer drug this year would give HLB Group two oncology drugs approved in the United States. The group received FDA approval last month for Rifixtu, a bile duct cancer treatment. Kim Hong-chul, chief executive of HLB, said: "Rifixtu is preparing for a U.S. launch in the fourth quarter of this year along with expansion into global markets including Europe." He stressed, "Rather than resting on our existing pipeline, we will continue to bring in new drug candidates to build a sustainable business structure."