The focus of Korea’s biotech sector is expected to shift from high-profile licensing deals in the first half of the year to clinical data readouts in the second half.
According to the Korea Biotechnology Industry Organization on the 1st, global licensing agreements signed by domestic pharmaceutical and biotech companies in the first half of the year exceeded approximately $8.7 billion in disclosed value. Companies including Hanmi Pharmaceutical, Oscotec, AriBio, Curacle and SK Plasma contributed to the surge in deal-making activity, lifting investor sentiment.
However, industry experts note that most licensing deals are structured with upfront payments and milestone-based royalties, meaning that headline deal values do not automatically translate into revenue unless clinical development and regulatory milestones are achieved. As a result, key clinical results and partnering events in the second half of the year are expected to serve as the next major performance benchmark for K-Bio.
The first major catalyst is expected from Kolon TissueGene, which is set to release top-line Phase 3 results in the U.S. this month for its osteoarthritis gene therapy TG-C. The company recently completed follow-up tracking for 1,020 patients and has begun final data analysis.
TG-C was approved in South Korea in 2017 as the world’s first gene therapy for osteoarthritis, but its approval was later revoked in 2019 after unauthorized changes to a key component were discovered. In 2020, the U.S. Food and Drug Administration allowed the trial to resume, leading to a renewed Phase 3 study conducted across 80 hospitals in the United States with around 1,000 patients. Dosing was completed in July 2024, followed by two years of follow-up, with results now set for release.
If results are positive, the company plans to submit a biologics license application to the FDA as early as the first quarter of next year, with a target U.S. launch in the second half of 2028.
ABL Bio is focusing on demonstrating the scalability of its Grabody-T platform through ABL111 in the second half of the year. ABL111 is a bispecific antibody targeting both Claudin18.2 and 4-1BB, being developed as a first-line treatment for gastric cancer.
In a Phase 1b trial, the drug showed objective response rates of 77% at the 8 mg/kg dose and 73% at the 12 mg/kg dose. A global Phase 2 trial is currently underway.
The company plans to release detailed Phase 1b data in the second half and aims to advance into a registrational Phase 3 trial in the fourth quarter. With FDA Fast Track designation, the program also has potential eligibility for accelerated approval.
For LegoChem Biosciences, the key variable is whether partner Johnson & Johnson will exercise its exclusive development option for the ADC candidate LCB84. LCB84 is a TROP2-targeting antibody-drug conjugate licensed out in December 2023 in a deal worth up to $1.7 billion.
Under the agreement, Johnson & Johnson would pay an additional $200 million to LegoChem if it exercises its exclusive development option during the clinical phase. The drug is currently in a Phase 1 trial in the United States for metastatic solid tumors, and the decision is viewed as a key indicator of the competitiveness of the company’s ADC platform.
For D&D Pharmatech, the key variable is partnering momentum for its MASH candidate DD01. MASH (metabolic dysfunction-associated steatohepatitis) is a fatty liver disease linked to obesity and diabetes, and has become a major target area for global pharmaceutical companies seeking metabolic disease pipelines.
In a U.S. Phase 2 study, DD01 demonstrated statistically significant improvements in fibrosis and MASH resolution based on 48-week biopsy data. Industry attention is now focused on whether the company will accelerate licensing or co-development discussions with global pharma partners in the second half.
An industry official said that while the first half of the year was defined by large licensing deals, the second half will be driven by clinical data and downstream development outcomes. “Clinical results, regulatory submissions, option exercises and partnering outcomes will be key inflection points for investor sentiment in K-Bio,” the official said.
