Despite 13 Trillion Won in Technology Exports, K-Bio Remains Quiet... All Eyes on Second Half Events

Overlooked Despite Positive Technology Exports in the First Half
Rebound Expected Upon Confirmation of Global Competitiveness

K-Bio will be put to the test on the global stage in the second half of the year. With the U.S. Food and Drug Administration (FDA) approval reviews, Phase 3 clinical trial results, and major international conferences such as the European Society for Medical Oncology (ESMO) scheduled, the competitiveness of new drug candidates held by Korean companies is expected to be thoroughly evaluated.

According to the pharmaceutical and biotech industry on July 6, this year’s second half is packed with approval and clinical data release schedules in key areas such as oncology, osteoarthritis, Alzheimer’s disease, and obesity/metabolic disorders. There is growing attention on whether the potential demonstrated by technology exports in the first half will be followed by approvals, clinical achievements, and subsequent partnerships in the second half. In particular, there is keen interest in whether the biotech sector, which was relatively overlooked as funds flowed into industries like semiconductors in the first half, can find an inflection point for recovery.

The most imminent event is whether HLB will receive approval for its liver cancer treatment. HLB’s first-line liver cancer treatment combining rivoceranib and camrelizumab is scheduled for FDA product approval review on July 23. Previously, in March 2024 and last year, HLB received Complete Response Letters (CRL) from the FDA, but the company explained that the issue was related to manufacturing and quality control (CMC) at the camrelizumab production facility, rather than the efficacy of the drug itself.

Kolon TissueGene is also expected to announce topline results from its U.S. Phase 3 clinical trial for the knee osteoarthritis cell and gene therapy TG-C this month. Given that existing osteoarthritis treatments have relied on painkillers, physical therapy, or surgery, if TG-C demonstrates structural improvement, it could be recognized as a potential disease-modifying therapy. The second set of Phase 3 results is anticipated to be released around October or November.

The global conference season will begin in earnest from October. At ESMO, there may be announcements regarding survival data for the combination therapy of Lekraza, a non-small cell lung cancer treatment by Yuhan Corporation and Oscotec, as well as data on HLX22, a HER2-targeted antibody new drug from AbClon. In addition, companies such as LigacchemBio, ABL Bio, and GI Innovation are expected to present follow-up data in areas such as antibody-drug conjugates (ADC), bispecific antibodies, and immuno-oncology drugs.

The topline global Phase 3 results of AR1001, Aribio’s oral Alzheimer’s treatment, are also expected to be released between September and October. As AR1001 is an oral medication, it stands out from currently prominent Alzheimer’s antibody treatments, which are administered intravenously, raising expectations for its convenience and commercial potential.

At SITC in November, attention will focus on immuno-oncology drugs and combination strategies, while at ASH in December, achievements related to hematologic cancers and cell therapies will be highlighted. For companies with pipeline candidates such as Chimeric Antigen Receptor T-cell (CAR-T) therapies, next-generation antibody drugs, and new drug candidates for hematologic cancers, these conferences represent potential opportunities for technology transfer or joint development discussions.

In the field of obesity and metabolic disorders, companies specializing in long-acting injectable platforms are expected to be key variables in the second half. Peptone, which is in the process of a technical evaluation for the development of a long-acting injectable obesity treatment with Eli Lilly, along with Inventage Lab and G2GBio, are attracting market attention to see if their platform technologies for reducing dosing intervals will lead to follow-up contracts.

Hyemin Heo, a researcher at Kiwoom Securities, stated, “Despite positive factors such as technology exports, clinical data releases, and M&A activity, K-Bio has been overlooked due to capital inflows into other sectors. If, in the second half, this concentration eases and global competitiveness, clinical data validation, and partnership achievements can be confirmed, it is expected that the sector will find a bottom and continue a trend of recovery.”

This content was produced with the assistance of AI translation services.