Eleva Attends 'Bio Europe Spring'... Preparing Riboceranib for European Market Entry

Eleva, HLB's U.S. subsidiary, participated in 'BIO Europe Spring' and has initiated the European marketing authorization application for rivoceranib as a first-line treatment for liver cancer, as well as preparations for subsequent commercialization.

BIO Europe Spring is the largest bio conference in Europe attended by pharmaceutical and biotech companies and investors worldwide. Many global pharmaceutical companies such as Novartis, Roche, and Pfizer attend annually. This year, it was held from the 20th to the 22nd in Basel, Switzerland.

Through the conference, Eleva discussed concrete plans for the commercialization of rivoceranib in Europe. Currently, HLB and Eleva have completed the global Phase 3 trial of rivoceranib as a first-line treatment for liver cancer and are preparing to submit a New Drug Application (NDA) to the U.S. FDA in May. Following the U.S. submission, approval procedures for major markets including Europe will proceed immediately. Along with preliminary research on the European market, considered a key market alongside the U.S., partnering discussions with multinational pharmaceutical companies were conducted.

HLB is prioritizing a sales strategy for rivoceranib that involves direct sales in the U.S. market and technology transfer for sales and distribution to partners in Europe. Starting with participation in the event, Eleva will discuss cooperation plans with multiple potential partners to secure smooth distribution networks.

Han Yonghae, CEO and Chief Technology Officer (CTO) of HLB Group, stated, "Since the presentation of the Phase 3 clinical trial results of rivoceranib at the recent European Cancer Congress, we have received numerous inquiries from specialists in the U.S., Europe, and other regions regarding commercialization plans and separate investigator-initiated clinical trials." He added, "Once the new drug approval becomes visible starting in the U.S., extensive follow-up clinical trials for multiple indications beyond liver cancer are expected to proceed."

HLB is pursuing a two-track strategy that simultaneously advances NDA preparation and commercialization efforts, including rapid production (CMC) and sales of rivoceranib. Starting with the U.S. NDA submission in May, sequential new drug applications will be pursued in multiple countries including Europe and Asia.