HLB's Lifictu Receives Standard FDA Approval... Market Size and Competing Drugs Explored

Standard Approval Without Conditions Unlike Competing Drugs

US Biliary Tract Cancer Market Worth 310 Billion Won Annually

"Direct Sales Synergy Expected if Liver Cancer Drug Is Approved"

HLB’s biliary tract cancer treatment, ‘Lifictu’ (ingredient name: lirafugratinib), is now officially set to enter the US biliary tract cancer market. The drug has received US Food and Drug Administration (FDA) approval as a second-line treatment for biliary tract cancer. While biliary tract cancer is a rare disease in the US—only about 8,000 new cases are reported annually, resulting in a relatively small market size—the industry is paying close attention as a Korean company has secured direct FDA approval for its new drug and is challenging global pharmaceutical companies that already dominate the targeted anticancer drug market.

Jinyangon, Chairman of HLB Group. HLB Group

According to the FDA on September 24, Lifictu has been approved as a treatment for adults with unresectable or metastatic advanced biliary tract cancer who have previously received anticancer therapy and have confirmed FGFR2 gene fusion or rearrangement.

This approval is a standard one, not accelerated. Two competing drugs that were previously launched received accelerated approval on the condition they complete confirmatory clinical trials, but Lifictu was approved without such conditions, based on objective response rate (ORR) and duration of response (DOR) demonstrated in clinical trials. For drugs with accelerated approval, the license can be revoked if efficacy is not confirmed in confirmatory trials. Unlike these, Lifictu can focus on sales without such a burden, which, despite being a latecomer, is regarded as having an edge in approval stability over its competitors.

Lifictu is a targeted anticancer therapy introduced to the US via HLB's American subsidiary, Elevar Therapeutics, which paid an upfront fee of 5 million dollars (about 6.8 billion won) to Relay Therapeutics (US) in December 2024. The total contract value, including the upfront fee and approval and commercialization milestones, can reach up to 500 million dollars (about 683.5 billion won). By the end of June this year, Elevar paid a total of 18.7 million dollars (about 25.6 billion won) in upfront fees, milestones, and active pharmaceutical ingredient transfer costs. Depending on future approval and sales performance, an additional payment of up to 485 million dollars (about 663 billion won) may be made. Royalties on post-marketing sales are separate. The specific milestone payment related to this approval has not been disclosed.

Entry into the US Biliary Tract Cancer Market Worth 310 Billion Won Annually

With this approval, Lifictu targets the US biliary tract cancer market, which is worth approximately 310 billion won annually. According to global market research firm MarketGlass, the US biliary tract cancer drug market was estimated at 227.1 million dollars (about 310.5 billion won) last year. The same report predicts that the global market will grow from 776.1 million dollars (about 1.061 trillion won) last year to 884.2 million dollars (about 1.209 trillion won) in 2032. FGFR2 fusion or rearrangement reportedly appears in about 10–15% of intrahepatic biliary tract cancer patients.

Lifictu’s competitors include Pemazyre (ingredient: pemigatinib) from Incyte in the US and Lyterovi (ingredient: futibatinib) from Daiichi Sankyo in Japan. Lifictu is the third entrant to the market. Last year, Pemazyre reported global sales of 86.7 million dollars (about 118.5 billion won).

Lifictu’s key point of differentiation is its precision. While the two other competing drugs inhibit multiple FGFR proteins at once, Lifictu selectively targets only FGFR2, the key driver in biliary tract cancer, thereby reducing the risk of side effects. Its efficacy numbers also come out ahead: Lifictu’s objective response rate (ORR) is 46%, higher than Pemazyre's (36%) and Lyterovi’s (42%).

Hepatocellular Carcinoma Drug FDA Resubmission Expected in October... Synergy Anticipated in Biliary Tract Cancer Direct Sales Network if Approved

HLB plans to leverage its experience commercializing Lifictu for its market strategy once FDA approval is obtained for its new hepatocellular carcinoma drug. Since the same physicians prescribe both biliary tract cancer and liver cancer treatments, the US sales network established for Lifictu can be directly applied to the launch of the liver cancer drug. An HLB official stated, “Since we plan to sell the new liver cancer drug directly, building the sales force will allow us to target both the liver and biliary tract cancer markets. The know-how accumulated from Lifictu direct sales will greatly assist rapid penetration into the liver cancer market.”

HLB is preparing for an FDA resubmission for its first-line hepatocellular carcinoma combination therapy—rivoceranib and camrelizumab—co-developed with Jiangsu Hengrui Pharmaceuticals in China. The company believes that the reason for the previous complete response letter (CRL), namely the active pharmaceutical ingredient manufacturing site review, has been resolved as it received a ‘Voluntary Action Indicated (VAI)’ recommendation, eliminating any licensing disqualifications. The latest safety data to be included in the resubmission are also in the final stages of preparation.

The remaining variable is the outcome of the finished drug product manufacturing site inspection. According to HLB, the FDA notifies the results within 90 days of the inspection's completion. This inspection was completed on July 3, so the deadline for notification is October 1. HLB, together with Hengrui Pharmaceuticals, is discussing whether to resubmit after confirming the result or to proceed before then. An HLB official commented, “We expect the inspection results to be communicated in early October,” and added, “Once we confirm the result, a resubmission is highly likely.”

This content was produced with the assistance of AI translation services.