[Edaily Reporter Kim Jinsoo ] Here are the clinical trial and product approval updates that garnered attention in the domestic pharmaceutical and biotech industry this week (October 12–16).

Aptabio Therapeutics Inc. Achieves Primary Endpoint in Phase 2 Trial

of APX-115 Aptabio Therapeutics Inc.(293780)Aptabio has met the primary endpoint of safety in the global Phase 2 clinical trial for “Isuzinaxib” (APX-115), which is being developed as a treatment for contrast-induced acute kidney injury (CI-AKI). Key efficacy results confirming its ability to prevent kidney damage are scheduled to be presented on the 23rd at the American Society of Nephrology (ASN) meeting.

Aptabio Therapeutics Inc. announced on the 15th that it has completed the safety evaluation for the Phase 2 clinical trial of Isuzinacxib conducted in South Korea and the United States.

A comprehensive analysis of adverse events, physical examinations, electrocardiograms, and clinical laboratory tests revealed no clinically significant differences between the treatment and placebo groups. No particular safety concerns were observed even in the high-risk patient group with impaired renal function.

This clinical trial was designed to enroll 160 patients undergoing percutaneous coronary intervention (PCI) at 14 medical institutions in South Korea and the United States. It is a randomized, double-blind, placebo-controlled proof-of-concept (PoC) study aimed at confirming the drug’s safety and therapeutic potential. However, efficacy data to assess its actual effectiveness in preventing kidney damage has not yet been released.

Aptabio Therapeutics Inc. will present the results of the analysis of key secondary endpoints at “Kidney Week 2026,” taking place in Denver, U.S., on the 23rd (local time). The study has been selected for a late-breaking oral presentation at the conference, and Professor Kwon Hyun-cheol of Samsung Medical Center will deliver the presentation. A separate study tracking changes in kidney function over 12 weeks following the onset of acute kidney injury will also be presented as a poster.

Aptabio Therapeutics Inc. is in discussions with multiple global pharmaceutical companies regarding technology licensing, with the goal of securing a Complete Study Report (CSR) in the first half of 2027. The company is considering not only standalone agreements for CI-AKI but also package deals that include diabetic kidney disease (DKD).

Lee Soo-jin, CEO of Aptabio Therapeutics Inc., stated, “Based on these topline results, we will accelerate our technology transfer discussions,” adding, “We expect discussions with potential partners to move to a more concrete stage.”

Meanwhile, CI-AKI is a complication characterized by a decline in kidney function following the administration of a contrast agent; currently, there are no approved drugs specifically intended to treat this condition. If Isuzinacxib demonstrates efficacy and safety in subsequent clinical trials, it has the potential to be developed as a first-in-class treatment.

LigaChem Biosciences Administer First Dose of ‘LCB02A’ in Phase 1/2 Trial in North America

#LigaChem Biosciences announced on the 16th that it has completed the first patient dosing in the global Phase 1/2 clinical trial of “LCB02A,” a new drug candidate under development that is a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC).

The first patient dosing took place on the 15th (local time) at a major clinical research site in North America. LigaChem Biosciences submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in April and received approval in May; with this first patient dosing, the company has now entered full-scale clinical development.

This clinical trial (NCT07460375) is a multinational, multicenter study involving up to 191 patients with CLDN18.2-positive advanced solid tumors who have failed standard treatment. The Phase 1 dose-escalation phase will evaluate safety and tolerability and identify the recommended Phase 2 dose (RP2D). Subsequently, in the Phase 2 dose-expansion phase, the company plans to verify antitumor efficacy in patients with CLDN18.2-expressing solid tumors, such as gastric cancer, gastroesophageal junction cancer, and pancreatic cancer.

LCB02A is a new drug candidate developed based on LigaChem Biosciences’ proprietary ADC platform, “ConjuAll™.” It is characterized by the site-specific conjugation of exatecan—a topoisomerase 1 (Topo1) inhibitor—to a CLDN18.2-targeting antibody.

In particular, the company has achieved a consistent drug-to-antibody ratio (DAR 4) by applying its proprietary linker technology, which ensures high stability in the bloodstream. This is also significant as it marks the first instance of expanding payload options to include Topo1 inhibitors, following the existing microtubule inhibitors MMAE, MMAF, and the PBD series.

CLDN18.2 is a protein highly expressed in certain solid tumors, such as gastric and pancreatic cancers, and is gaining attention as a key target for the development of next-generation anticancer drugs. Currently, Astellas’ monoclonal antibody “Viloiy” (generic name: zolbetuximab) is the only approved therapy targeting CLDN18.2; however, no CLDN18.2-targeted ADC has yet been approved worldwide.

LigaChem Biosciences plans to present two posters at the European Society for Medical Oncology (ESMO) Annual Congress 2026, to be held in Madrid, Spain, from the 23rd to the 27th. The posters will cover the preclinical study results for LCB02A and the design of its global Phase 1 and 2 clinical trials. Through these presentations, the company intends to highlight the technical distinctiveness of LCB02A and outline its future clinical development strategy.

Park Se-jin, CEO of LigaChem Biosciences, stated, “The first patient dosing of LCB02A is highly significant as it marks the full-scale entry into the clinical phase of our payload diversification strategy, which combines the Conjuol platform with a Topo1 inhibitor payload,” he said. “We will conduct clinical trials swiftly in collaboration with world-renowned cancer centers to demonstrate LCB02A’s differentiated competitiveness in the CLDN18.2 ADC market through data.”

HLB INC.’s First-Line Liver Cancer Treatment Resubmits Application for FDA Approval

HLB INC.(028300)has completed the

resubmission

of its application for U.S. Food and Drug Administration (FDA) approval of a new liver cancer drug

and

is once again seeking approval. As the company has been proceeding with the relevant procedures since receiving a Complete Response Letter (CRL) from the FDA, attention is focused on the outcome of this review.

HLB INC. announced that its U.S. subsidiary, Eleva Therapeutics, and its Chinese partner, Hangzhou Pharmaceutical, submitted a New Drug Application (NDA/BLA) to the FDA on the 9th (local time) seeking approval for the combination therapy of riboceranib and camrelizumab as a first-line treatment for liver cancer.

Previously, in July of this year, the FDA issued a CRL regarding the new drug application submitted by Eleva in January. Since then, Eleva and Hengrui Pharmaceuticals have been in discussions with the FDA to address the requested revisions and have now resubmitted the application.

This application is based on the results of the global Phase 3 “CARES-310” clinical trial. In the final analysis, the combination therapy of riboceranib and camrelizumab achieved a median overall survival (mOS) of 23.8 months in patients with unresectable or metastatic liver cancer. This is 8.6 months longer than the 15.2 months observed in the sorafenib control group, representing a 36% reduction in the risk of death (HR=0.64, 95% CI 0.52–0.79, P<0.0001).

Notably, the 23.8-month survival period is the longest reported to date among clinical trial results for first-line treatments for liver cancer. Consistent treatment efficacy was observed across various patient subgroups.

The final analysis results of CARES-310 were published last December in the international journal *The Lancet Oncology*. Although the combination therapy of riboceranib and camrelizumab has not yet received FDA approval, its clinical value has been recognized, and it has been recommended as a first-line treatment option for liver cancer in the 2025 Barcelona Clinic Liver Cancer (BCLC) treatment strategy and the European Society for Medical Oncology (ESMO) guidelines.

Kim Dong-geon, CEO of Eleva Therapeutics, stated, “Unresectable liver cancer remains an area with high unmet medical needs, and we have continued our efforts to provide new treatment options for patients and healthcare professionals.” He added, “Now that the manufacturing facility inspection has been completed, we will work closely with the FDA to ensure that the approval review is successfully concluded based on the clinical value confirmed in the CARES-310 trial.”