HLB's Cholangiocarcinoma Drug "Lirapugratinib" Enters Full-Scale European Approval Review

The full-scale review for European approval of HLB's new drug for cholangiocarcinoma, "Lirapugratinib," has begun.

According to HLB's U.S. subsidiary, Elevar Therapeutics, the company applied for European marketing authorization for Lirapugratinib on September 14 (local time) as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement. Just over two weeks later, on October 1, the European Medicines Agency (EMA) notified the company that the full review process had started.

Lirapugratinib received formal approval from the U.S. Food and Drug Administration (FDA) under the brand name "RYPHYKTO" on September 23. Elevar plans to launch RYPHYKTO directly in the United States in the fourth quarter of this year, and with the initiation of the EMA review, the company intends to accelerate its entry into the European market as well.

Elevar is also conducting development to expand Lirapugratinib's therapeutic scope to other solid tumors. The company is currently carrying out the global phase 2 clinical trial "ReFocus202," evaluating the potential of Lirapugratinib as a tumor-agnostic therapy for various solid tumor patients with FGFR2 fusion or rearrangement.

Kim Donggun, CEO of Elevar, stated, "With Lirapugratinib, which has received formal approval in the United States as RYPHYKTO, now entering the full review phase in Europe, the procedures to expand into the global market are progressing smoothly. Elevar will actively respond to the EMA review while simultaneously pushing forward with U.S. commercialization and the expansion of additional indications to continuously enhance the global value of Lirapugratinib."

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