HLB Affiliate Wins First FDA Approval for a Drug Developed by a Korean Company: Bile Duct Cancer Treatment

A drug developed by a Korean company has received approval from the U.S. Food and Drug Administration (FDA) for the first time.

According to Fierce Pharma on the 25th (local time), the FDA approved lirfipigto, Elevation Therapeutics’ treatment for bile duct cancer. Elevation is an affiliate of South Korea’s HLB Group, and this marks the first time the FDA has approved a drug developed by a Korean company.

Lirfipigto is a selective FGFR2 inhibitor licensed from Relay Therapeutics. In clinical trials, it posted an objective response rate of 46% and a median progression-free survival of 11.3 months.

Meanwhile, Eli Lilly signed a co-research agreement with China’s InnoCare Pharma covering five targets. Lilly will pay $100 million in upfront and near-term payments, with up to an additional $3.25 billion in milestone payments. The targets and therapeutic areas were not disclosed.

The Chinese government announced its 2026-2030 five-year plan for the pharmaceutical industry, setting a goal of capturing 25% of the global market for first-in-class drugs at the clinical or approval stage. The plan also aims to develop 50 pharmaceutical companies with annual sales of at least 10 billion yuan (about $1.5 billion) and create five global blockbuster drugs.

U.S. Sen. Todd Young argued that the White House should appoint a dedicated biotechnology official who reports directly to the president to counter China’s rise in biotechnology. Young chairs the Emerging Biotechnology National Security Commission.