Development pipelines are entering clinical trials faster

Domestic biotech companies are moving into a phase where the value of candidate substances is proven through actual entry into clinical trials and first patient dosing. IKS04, which applies the LigaChemBio platform, received approval for its investigational new drug application in the United States; Cellbion’s pocuvotide entered combination clinical trials with an immuno-oncology therapy; and CGBio’s Novosis Putty also completed its first procedure in a U.S. confirmatory trial.

This trend goes beyond the performance of individual companies and shows that the development model itself is being reorganized around late-stage clinical trials and simultaneous global development. In fact, domestic biopharmaceutical clinical trials totaled 61 in the second quarter, with ADCs accounting for 14 of them, indicating that antibody-based therapies are leading development in areas close to commercialization.

Regulation is being adjusted in two directions: easing and greater precision

The government is redesigning regulations to reduce uncertainty for innovative technologies while strengthening post-market oversight of manufacturing quality. Based on about 1,000 review cases of digital medical device software, the Ministry of Food and Drug Safety clarified the criteria for which products can be approved using only performance verification data without clinical trials. It also introduced a system under which veterinary drug manufacturing facilities must undergo re-examination every three years starting in 2027.

This is interpreted as a policy response aimed at keeping pace with technological change without losing market trust. Financial authorities, through the Comprehensive Improvement Task Force on Pharmaceutical and Bio Disclosures, revised disclosure practices so that information is centered more on figures and conditions than on exaggerated expressions. In the healthcare assessment field, the scope of clinical evidence is also expanding with the establishment of guidelines for generating real-world evidence (RWE) for drug outcome evaluation using actual treatment data.

Data and digital technologies are changing how clinical trials are operated

The core of clinical competitiveness is expanding from the candidate substance itself to operational speed and the ability to use data. Seoul Asan Medical Center has begun reducing delays in research initiation by introducing an electronic signature system in contracts with global pharmaceutical companies, while Oprimed is pushing for a virtual patient simulation hub in Chuncheon based on a digital twin platform.

This change arose from the need to complement the limitations of costly clinical trials and animal testing. Severance Hospital is building an AI-based evaluation platform for Parkinson’s cell therapies backed by a total of 7 billion won in research funding, while the Ministry of Food and Drug Safety is transferring liver organoid toxicity evaluation technology to industry and is even aiming for international standardization of human-based predictive models.

The burden of validation and ethics grows alongside the speed of expansion

The faster technology advances, the more important verification systems and ethical controls become. In China, it was later revealed that a six-year-old girl died in the course of receiving an expensive gene-editing treatment, sparking controversy over the appropriateness of treatment proposals, risk disclosure, and research transparency.

Clinical trials are now connected not only to medical research but also to issues of security and supply chains. The fact that the U.S. Congress has begun examining a global pharmaceutical company’s record of conducting 224 clinical trials in China and its data handling processes shows that clinical data and research infrastructure are increasingly being recognized as part of national competitiveness.