HLB Group to Kick Off the Year with Major Milestones

Key Pipeline Milestones in Liver Cancer, Biliary Tract Cancer, CAR-T, and Rare Ophthalmic Diseases
From FDA Resubmission to Phase 3 Top-Line Results

HLB Group is preparing for another leap forward by pushing ahead with a series of major milestones scheduled for the new year. As next-generation drug pipelines-such as therapies for liver and biliary tract cancer, CAR-T treatments for hematologic and solid tumors, and treatments for rare ophthalmic diseases-enter full-scale development, the company's status as a global pharmaceutical innovator is becoming increasingly prominent.

According to the biotech industry and HLB on January 7, HLB plans to resubmit its new drug application to the U.S. Food and Drug Administration (FDA) for the "Rivoceranib + Camrelizumab combination therapy." HLB is expected to submit the resubmission documents this month to obtain approval for this combination therapy as a first-line treatment for liver cancer.

HLB's new liver cancer drug previously recorded the longest median overall survival (mOS) ever achieved as a first-line treatment in a global Phase 3 clinical trial. The final analysis of this clinical trial was recently published in the prestigious international journal The Lancet Oncology, drawing significant attention from the academic community.

Buoyed by these clinical results, the Rivoceranib combination therapy was listed as a first-line treatment in both the European Society for Medical Oncology (ESMO) "Diagnosis and Treatment Guidelines for Hepatocellular Carcinoma" and the "Barcelona Clinic Liver Cancer (BCLC) Guidelines," which are recognized as standards for liver cancer treatment strategies, even before FDA approval.

HLB also plans to submit a new drug application (NDA) to the FDA for "Lirafugratinib," another novel compound, as a second-line treatment for biliary tract cancer. According to an abstract released ahead of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026), Lirafugratinib achieved an objective response rate (ORR) of 47% in a global Phase 2 clinical trial, demonstrating competitive clinical results compared to existing therapies.

The FDA designated Lirafugratinib as a "Breakthrough Therapy" in October 2023, recognizing its significant clinical relevance and therapeutic potential in the field of biliary tract cancer. As drugs with Breakthrough Therapy designation are highly likely to receive "Priority Review," the review process following the application is expected to proceed more rapidly.

HLB will also attend the upcoming JP Morgan conference this month, where it plans to hold business meetings with numerous global companies and actively expand its network with international investors. Through these efforts, the company aims to secure strategic investment opportunities that align with the growth stage of its pipeline.

The next-generation CAR-T therapy under development by HLB Innovation is also expected to reach a significant milestone in the first half of this year. Interim results from the ongoing Phase 1 clinical trial of the solid tumor-targeting CAR-T therapy "SynKIR-110" are set to be presented at major medical conferences. According to data presented at the American Society of Clinical Oncology (ASCO) in June last year, SynKIR-110 progressed through cohort 3 of a total of six clinical cohorts without any dose-limiting toxicity (DLT).

HLB Innovation's CAR-T platform, "KIR-CAR," was developed with a focus on overcoming T-cell exhaustion, a major limitation of existing CAR-T therapies. By applying KIR receptors, found in immune NK cells, to T cells, the platform allows CAR-T cells to "rest" periodically, enabling them to maintain their efficacy in the body for a longer period.

Additionally, another new drug pipeline from HLB Innovation, the relapsed hematologic cancer CAR-T therapy "SynKIR-310," is expected to have interim Phase 1 clinical results presented at a conference within this year. In recent preclinical studies, SynKIR-310 demonstrated superior efficacy compared to Kymriah, attracting significant industry attention.

HLB Therapeutics plans to announce top-line results from the U.S. Phase 3 clinical trial (SEER-2) of its treatment for neurotrophic keratitis (NK) in June. These clinical results are expected to be a key factor in ongoing technology transfer negotiations with global pharmaceutical companies.

In addition to new drug development, significant growth is anticipated from the group's diagnostics and materials affiliates. HLB Panagene, which possesses outstanding capabilities in the PNA diagnostics field, has officially launched its spatial proteomics analysis equipment "Hyperion" service and is planning to produce its own spatial proteomics data. Through collaboration with its partner, AI drug discovery company Arontier, and major domestic hospitals, the company aims to generate valuable data for elucidating the tumor microenvironment and achieve diagnostic results based on AI analysis. The results of this research are expected to be released in the first half of this year.

HLB Peptide will also accelerate new business initiatives based on its accumulated peptide technology expertise. In addition to ongoing development of diabetes and obesity treatments, the company plans to enter the peptide-based anti-cancer drug field, securing mid- to long-term growth drivers. Starting this year, it will leverage its proprietary cancer-targeting peptide (AGM-330) to develop radiopharmaceutical targeted therapies (RPTs). To this end, HLB Peptide recently signed a joint development agreement with radiopharmaceutical research company Raymed.

A representative from HLB Group stated, "With strategic events such as new drug approvals and clinical result announcements concentrated in 2026, this year will be a 'year of global advancement.' Beyond new drug development, we will further solidify our position as an integrated healthcare group encompassing CGT platforms, RPT anti-cancer drugs, and AI-based research."