HLB Group Chairman Yang-gon Jin. Photo = HLB
HLB has outlined its next steps as it approaches two key U.S. Food and Drug Administration (FDA) review decisions this year. With approval decisions for rivoceranib in liver cancer and lirafugratinib in biliary tract cancer expected in July and September, respectively, the company used its latest forum to highlight the broader expansion potential of both pipelines, as well as its next-generation CAR-T platform strategy.
At the 2026 HLB Forum, held on May 12 at Sofitel Ambassador Seoul, HLB Group Chairman Yang-gon Jin said, “This year, HLB is expecting approvals for two oncology drugs in liver cancer and biliary tract cancer. If approved, it would mark the company’s first success in oncology drug development, 20 years after it began the effort.”
Jin added that the theme of this year’s forum was “the DNA of success, the continuity of innovation, and the challenge that never stops,” emphasizing that “HLB’s goal is not success, but growth.”
HLB is seeking FDA approval for rivoceranib in combination with camrelizumab as a first-line treatment for liver cancer through its U.S. subsidiary Elevar Therapeutics. The FDA is expected to make its decision by July 23. Lirafugratinib has also been granted Priority Review for biliary tract cancer, with a decision expected by September 27.
At the forum, HLB emphasized that both rivoceranib and lirafugratinib have potential beyond their initial indications. The strategy appears aimed at securing long-term growth regardless of the near-term FDA review outcomes, with possible expansion into additional treatment settings and cancer types.
Verismo’s KIR-CAR Platform Signals Move Into Next-Generation Modalities
HLB Group Executive Director Ji-hwan Lee. Photo by Reporter Sun-kyung Kim
Verismo’s CAR-T platform emerged as a key focus at the forum, as HLB seeks to expand into next-generation, platform-based drug development.
HLB Group Executive Director Ji-hwan Lee said existing CAR-T therapies, despite their success in blood cancers, face major limitations in solid tumors. He described conventional CAR-T therapies as structures in which T-cell activation proteins are artificially arranged in a single chain, citing poor access to solid tumor sites, antigen recognition failure and T-cell exhaustion as key challenges.
Lee also pointed to tumor recurrence as a major issue. Based on a glioblastoma case reported in a 2024 paper and long-term data for Kymriah, he noted that tumors may initially disappear after treatment but later return in many patients.
He identified “tonic signaling” as a possible cause of recurrence. This refers to continuous T-cell activation regardless of antigen presence, which can cause the cells to lose energy prematurely. Lee compared it to “a car that must reach its destination but burns fuel while parked because the engine keeps running, eventually stopping midway.”
Lee said Verismo has developed KIR-CAR, a new platform designed to overcome these limitations by using natural signaling systems.
“Unlike conventional single-chain CARs that remain continuously activated, Verismo’s SynKIR technology is activated only when it binds to cancer cells, which may allow for longer persistence,” Lee said.
Verismo’s SynKIR technology uses a dual-molecule structure composed of an antibody and the natural NK-cell proteins KIR and DAP12. According to the company, the system is activated only when it binds to cancer cells, supporting longer persistence.
Lee added that very few CAR-T therapies have shown meaningful results in solid tumors, noting that while competitors have made partial modifications to existing CAR structures, Verismo is applying a different platform approach.
Rivoceranib Combination Expands Across Liver Cancer Treatment Settings
Professor Chang-hoon Yoo of Asan Medical Center. Photo by HLB
Professor Chang-hoon Yoo of Asan Medical Center said the rivoceranib-camrelizumab combination is expanding beyond advanced liver cancer into perioperative treatment and combination strategies with local therapies.
“In the CARES-310 study, the combination improved both progression-free survival (PFS) and overall survival (OS) in patients with unresectable hepatocellular carcinoma,” Yoo said. “It is meaningful as the first case in which an immune checkpoint inhibitor and tyrosine kinase inhibitor (TKI) combination met dual primary endpoints.”
Yoo added that in the CARES-009 study, which evaluated patients with resectable hepatocellular carcinoma, perioperative combination therapy significantly improved event-free survival (EFS) and major pathological response (MPR).
“Surgical feasibility was also maintained, confirming its potential as a perioperative treatment strategy,” he said.
Yoo also noted that a three-drug regimen combining the therapy with TACE improved progression-free survival and objective response rate (ORR).
“From unresectable advanced hepatocellular carcinoma to perioperative treatment and local therapy combinations, the regimen is establishing itself as an evidence-based treatment option across the hepatocellular carcinoma treatment landscape,” he said.
Additional findings for rivoceranib in other cancer types were also presented. Professor Myung-joo Ahn of Hanyang University Hospital shared study results in patients with metastatic thymic epithelial tumors (TET), reporting an objective response rate of 38.9% and a disease control rate of 94.4%.
“Rivoceranib showed meaningful clinical efficacy and durable disease control in patients with metastatic TET,” Ahn said.
FGFR2-Targeting Lirafugratinib Shows Tumor-Agnostic Potential
Lirafugratinib was also highlighted as an asset with potential across multiple cancer types. Professor Vivek Subbiah of Stanford University introduced tumor-agnostic therapy as a major trend in global oncology drug development. The approach expands treatment eligibility based on specific genetic mutations, rather than the organ where the cancer originated.
“Tumor-agnostic therapy represents a paradigm shift in oncology because it targets specific genetic drivers beyond the organ or histological type of the tumor,” Subbiah said. “Since the FDA approved pembrolizumab as the first tumor-agnostic therapy in 2017, the development of therapies targeting specific gene fusions or mutations has rapidly expanded. What matters now is not only where the cancer arises, but what biomarker, or genetic profile, it carries.”
Professor Richard Kim of the Moffitt Cancer Center at the University of South Florida said lirafugratinib is being developed in line with this trend.
“Lirafugratinib targets FGFR2 genetic alterations. After first establishing its therapeutic position in biliary tract cancer, it is expanding into other solid tumors with FGFR2 alterations,” Kim said. “In the ongoing tumor-agnostic study, responses are also being observed in several cancer types beyond biliary tract cancer.”
External experts said HLB’s two-track strategy — expanding its core pipelines while securing next-generation platforms — is critical for sustainable growth.
Young-min Park, head of the Korea Drug Development Fund (KDDF), said companies can no longer rely on a single candidate or pipeline.
“In the past, companies competed with a single candidate or a single pipeline, but that is extremely difficult. If one candidate fails, the company itself can collapse,” Park said.
“What matters is whether a company has built a strong portfolio so that, even if one asset fails, another can follow and support long-term sustainability. The future of new drug development will depend not on owning a single technology, but on strategic flexibility and structural design. HLB Group is currently moving well in that direction,” he added.
Korea Pharmaceutical and Bio-Pharma Manufacturers Association Chairman Yeon-hong Noh. Photo by HLB
KDDF Head Young-min Park. Photo by HLB
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