HLB Applies for Pre-Clinical Meeting with US FDA for Bile Duct Cancer Treatment

[Financial News] HLB announced that its US subsidiary Elevar Therapeutics applied for a pre-NDA meeting with the US Food and Drug Administration (FDA) on the 30th for the new drug application of the bile duct cancer treatment 'Lirapugratinib (RLY-4008)'. A Pre-NDA meeting is a procedure to coordinate clinical results, submission data composition, and approval strategies with the FDA in advance of submitting a New Drug Application (NDA) to increase the likelihood of new drug approval.
Lirapugratinib has demonstrated excellent therapeutic effects, high target selectivity, and superior tolerability in early clinical trials targeting FGFR2 fusion bile duct cancer patients, and has been recognized for its potential for significant therapeutic innovation in the area of bile duct cancer, which lacks treatment options. As a result, it was designated as an 'innovative drug' by the US FDA in 2023. Accordingly, it is highly likely to be designated as a 'priority review' target when submitting the NDA, and the review period will be shortened from the existing 10 months to 6 months.
In fact, in the global Phase 2 clinical trial targeting FGFR2 fusion mutation bile duct cancer patients, superior effects were confirmed in major efficacy indicators such as objective response rate (ORR) and duration of response (DOR) evaluated based on the Independent Review Committee (IRC) criteria, surpassing existing treatments, and cases of complete remission (CR) were also reported.
In terms of safety, the incidence of major side effects such as diarrhea and hyperphosphatemia was significantly lower compared to existing approved treatments, proving its differentiation and competitiveness as a 'Best-in-Class' drug.
Since the Pre-NDA meeting is usually held within 60 days of application, the company expects the meeting to be held around the end of September.
Currently, Elevar is preparing to submit data focusing on key issues to be discussed with the FDA ahead of the Pre-NDA meeting, while meticulously reviewing core materials, including clinical data, to maximize the success potential of the NDA.
In particular, thorough preparation is being made across the NDA submission requirements, including GMP eligibility review for Lirapugratinib active pharmaceutical ingredients and finished pharmaceuticals.
HLB is diligently resolving CMC-related supplementary matters through consultations with its partner Hansoh Pharmaceutical for the combination therapy of Rivoceranib+Camrelizumab, which is being developed as a liver cancer treatment, and plans to secure new drug approvals sequentially for both indications through thorough preparation for the bile duct cancer treatment Lirapugratinib.

Yonghae Han, HLB Group's Chief Technology Officer (CTO), stated, “The main data based on IRC secured from the global Phase 2 clinical trial will be announced at 'ASCO GI 2026' next year, and the NDA submission for the second-line treatment of bile duct cancer is proceeding without any issues according to the scheduled timeline.” He added, “The global expansion clinical trial targeting FGFR2 mutations, aiming for approval as a 'tumor-agnostic treatment', is also progressing smoothly.”

vrdw88@fnnews.com Jungmo Kang Reporter