[The New Path for Bio, Anti-Aging]② The Unsolved Challenge of Anti-Aging Drugs Even for Big Pharma—Korea's "Opening"

Calico and AbbVie's $2.6 Billion Project Yields No Results
Regulatory Shift at FDA Opens Opportunities in Data and Regenerative Medicine

① 'The Battle Against Aging' Becomes a New Global Industry

② Even Big Pharma Has Not Cracked Anti-Aging Drugs, but There Are 'Opportunities' for Korea

③ Why Did Samsung, Once Ahead of Google, Fall 13 Years Behind in Anti-Aging Research?

④ K-BigHeart Dreams of Becoming the Korean IMEC

There have not yet been any successful examples of anti-aging drugs. For over a decade, global pharmaceutical and big tech companies have poured capital into the field, but none of their drug candidates have received approval from the U.S. Food and Drug Administration (FDA). The repeated failures of first-generation anti-aging drug candidates have demonstrated that success is not determined by financial resources alone. Analysts say that opportunities for Korean biotech do not lie in investments on the scale of Big Pharma, but rather in precision data and differentiated strategic approaches.

According to the pharmaceutical and biotech industries on May 13, anti-aging drugs are those that directly modulate the molecular mechanisms of aging to delay the onset of age-related diseases. Representative strategies include selectively eliminating senescent cells that promote inflammation, reversing differentiation clocks, or blocking accelerated aging metabolic pathways. This is fundamentally different from existing drugs that treat individual diseases after they develop.

Even large-scale investments have not yielded results. The joint development collaboration between Alphabet subsidiary Calico and AbbVie, which began in 2014 to target aging-related diseases, invested over $1.75 billion (about 2.5812 trillion won) over 11 years, but did not achieve a single new drug approval before ending in November last year. Even the combination of big tech and big pharma, equipped with both capital and data infrastructure, failed to overcome the biological complexity of aging.

The failure of Calico and AbbVie is considered the result of both scientific and institutional limitations. The appearance and function of senescent cells vary by tissue, so there is no single target protein or biomarker that acts uniformly on all senescent cells. Drugs targeting a single mechanism struggle to show consistent effects in actual patients. Regulatory issues have also hampered the research design process. Because the FDA does not recognize aging as a standalone indication, companies must design clinical trials using age-related conditions such as osteoarthritis, macular degeneration, or fibrotic diseases as indications. Even if a drug targets the mechanisms of aging, the evaluation criteria end up focusing on symptom improvement for individual diseases.

Efforts to overcome regulatory barriers are already underway in the United States. One example is the TAME (Targeting Aging with Metformin) clinical trial, which uses metformin—widely prescribed for type 2 diabetes—as a candidate. The trial, involving 3,000 participants, uses the onset of age-related conditions such as myocardial infarction, heart failure, stroke, cancer, dementia, and death as primary endpoints, with its design reflecting input from the FDA. Although the trial has been delayed due to funding issues, it is significant in that the FDA has, for the first time, accepted evaluation measures that closely approximate aging itself. Industry experts see this as opening the door to a new regulatory paradigm, shifting the industry's competitive focus from capital investment to the precision of data and biomarkers.

Experts say that Korea can leverage its faster clinical trial and approval process for regenerative medicine compared to the United States. Thanks to the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (ARMABSA) enacted in 2020, and upcoming regulatory reforms in 2025, Korea now has a relative advantage over the U.S. and Europe in the speed at which cell and gene-based therapies can enter clinical trials. This structure enables domestic regenerative medicine companies targeting age-related diseases to move into clinical stages faster than their global counterparts.

Korea also boasts world-class medical and health data infrastructure. The country is among the global leaders in the accumulation of electronic medical records (EMR), national health screening data, and biobank resources. Precision aging analysis platforms that combine epigenetics, single-cell analysis, and multi-omics with artificial intelligence (AI) are seen as areas where the depth and integrity of data matter more than the scale of capital. Paek Seungpil, Professor of Bioinformatics Engineering at Korea University Sejong Campus and Director of the Convergence Leading Research Center for Anti-Aging Based on Biological Clocks, said, "It is difficult to compete head-to-head with global big tech in terms of capital. The most realistic and competitive approach is the convergence of precision data, AI, chronobiology, and natural product materials."

Chronobiology-based precision medicine is also cited as a Korean strength. Cellular recovery, metabolism, DNA repair, and immune function are all influenced by biological clock rhythms. The efficacy and toxicity of the same drug can vary depending on the time of administration. Analysts believe that even with modest capital, candidates with high industrial value can be discovered in the fields of drug repurposing and personalized dosing optimization.

Professor Paek emphasized, "Many molecular mechanisms that drive aging are directly linked to disruptions in biological clock rhythms. Precision medicine based on chronobiology, which optimizes drug dosing times and the timing of cell reprogramming to match body rhythms, will emerge as a key pillar of the anti-aging industry." He also suggested that Korea could leverage its strengths by refining natural and marine bio materials, which impact mitochondrial function, inflammation control, and biological clock stabilization, into single substances with clear mechanisms of action and developing them into chronobiology-based drug formulations.