"While various competing drugs exist in the first-line liver cancer treatment market, HLB's (028300.KQ) 'Rivoceranib' combination therapy stands out with competitive survival outcomes and more favorable safety data. Beyond the new drug currently under U.S. Food and Drug Administration (FDA) review, our goal is to grow into a sustainable company that can continuously generate new drug pipelines."
Kim Dong-gun, CEO of Elevar Therapeutics, made these remarks in a written interview with The Seoul Economic Daily on Tuesday. Kim attended the American Society of Clinical Oncology (ASCO) 2026 held in Chicago from May 29 to June 2 (local time), where he introduced the liver cancer drug Rivoceranib combination therapy under FDA review and the bile duct cancer drug 'Lirafugratinib' to key opinion leaders (KOLs) in the local medical community. Elevar Therapeutics is HLB's U.S. subsidiary responsible for new drug development and FDA approval processes for drugs including Rivoceranib.
Kim particularly expressed expectations that the Rivoceranib combination therapy would receive positive results in the FDA's re-examination. This marks the third attempt following Complete Response Letters (CRL) received from the FDA in 2024 and last year. The FDA will decide by July 23 whether to approve the Rivoceranib and 'Camrelizumab' combination therapy as a first-line treatment for liver cancer. "I believe the key to the re-examination lies in confirming whether the Chemistry, Manufacturing, and Controls (CMC) issues raised by the FDA in the previous CRL have been sufficiently resolved," Kim said. "Quality assurance (QA) and CMC experts at our partner Jiangsu Hengrui Pharmaceuticals in China have submitted additional data and supplementary materials to demonstrate that the FDA's concerns and issues have been addressed."
There are also concerns that Rivoceranib's combination therapy may face uncertain competitiveness, as multiple rival drugs have already been launched in the liver cancer treatment market. Moreover, the 'Opdivo' and 'Yervoy' combination therapy approved by the FDA last year showed median overall survival (mOS) of 23.7 months, not significantly different from the Rivoceranib and Camrelizumab combination therapy (23.8 months). However, regarding this, Kim pointed out, "Looking at the survival curve of the Opdivo-Yervoy combination therapy, the curve crosses with that of the comparator drug 'Sorafenib' at around 12 months. This means that during the initial 12 months, patients may either show a good response or experience intolerable adverse reactions." He continued, "In contrast, the Rivoceranib combination therapy shows curve crossover at around 2 to 3 months, allowing early determination of whether to continue treatment before adverse reactions appear. It is also differentiated in that it has no gastrointestinal bleeding side effects, unlike the standard treatment combination of 'Tecentriq' and 'Avastin,' and offers longer mOS than the 'Imfinzi' and 'Imjudo' combination therapy."
The FDA will also decide in September whether to approve Lirafugratinib as a second-line treatment for bile duct cancer. Lirafugratinib treats bile duct cancer by inhibiting fibroblast growth factor receptor 2 (FGFR2), which acts as a growth switch for cancer cells. "While existing FGFR inhibitors block FGFR 1, 2, 3, and 4 all together, posing relatively higher toxicity risks, Lirafugratinib selectively inhibits FGFR2 to minimize unnecessary toxicity," Kim said. "Based on this precision, we are also conducting Phase 2 clinical development to expand treatment to various cancer types related to FGFR2." He added, "High selectivity can also help reduce overlapping toxicity when combined with other treatments and improve treatment continuity, which can be a strength in terms of combination strategy."
"Both the Rivoceranib combination therapy and Lirafugratinib target areas with high unmet medical needs and are showing potential to become meaningful treatment options based on clinical data," Kim said. "If FDA approval is granted, it will become an important milestone proving the HLB Group's global new drug development capabilities, and we expect it to have a positive impact on additional indication expansion, global business development (BD), and follow-up new drug development."
However, Kim believes approval of these new drugs should not be the ultimate goal. "For sustainable growth, we need to build a company that can continuously create new drug pipelines, not just one or two products," he stressed. "We will work to strengthen our capabilities from discovering treatments developed in the market and evaluating their potential, to crossing regulatory hurdles and commercialization, and to be recognized as an attractive partner by global new drug development companies."
