HLB has once again made waves in the global cancer drug market.
On Monday, industry sources reported that HLB’s U.S. subsidiary, Elevar Therapeutics, presented phase 2 clinical trial results for its cancer drug candidate, lirafugratinib, at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI 2026) in San Francisco from January 8-10.
The presentation was featured as one of the 15 Must-See Presentations at ASCO GI 2026 by OncoDaily, a leading global oncology publication, acknowledging both its clinical significance and academic merit.
This oral presentation marks a pivotal moment for HLB, introducing its next-generation flagship pipeline to the global stage, following the success of its liver cancer treatment, rivoceranib. Elevar is set to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lirafugratinib later this month.
Lirafugratinib was originally developed by Relay Therapeutics, a U.S.-based AI-driven drug discovery company. From its inception, Relay has prioritized precision targeting and selectivity in drug design, aiming to minimize side effects by targeting specific mutations or receptors.
As Relay’s inaugural pipeline product, lirafugratinib is engineered to selectively inhibit only Fibroblast Growth Factor Receptor 2 (FGFR2), with the goal of minimizing toxicities observed in existing pan-FGFR inhibitors.
In December 2024, Elevar Therapeutics secured the global exclusive license for lirafugratinib from Relay. At that time, clinical trials were underway in multiple countries, with patient recruitment for cholangiocarcinoma completed and data presentations imminent.
Lirafugratinib’s selective targeting of FGFR2 represents a significant milestone, as this clinical trial is the first to validate this concept in practice. The results suggest that lirafugratinib could emerge as a competitive treatment option for patients with FGFR2 as a biomarker.
While seeking FDA approval for lirafugratinib as a second-line treatment for cholangiocarcinoma, Elevar is also conducting clinical trials to expand its indications to various cancer types sharing FGFR2 fusion and rearrangement characteristics. This strategy aims to develop lirafugratinib into a precision oncology drug targeting FGFR2 mutations across multiple cancer types, beyond a single indication.
Market analysts predict that the clinical results unveiled at ASCO GI, demonstrating competitive efficacy and safety compared to existing pan-FGFR inhibitors, may lead to a favorable evaluation during the approval process.
An HLB spokesperson stated that Lirafugratinib is being developed as a precision oncology drug that extends beyond cholangiocarcinoma, leveraging FGFR2 as a clear biomarker. Starting with this ASCO GI presentation, the goal is to systematically advance clinical trials across various cancer types following approval for cholangiocarcinoma, ultimately establishing lirafugratinib as a global treatment option.