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It has been confirmed that Samsung Bioepis has begun developing a biosimilar of the antibody-drug conjugate (ADC) blockbuster 'Enhertu.' Among next-generation modalities (therapies), ADCs are drawing particular attention as a core technology, yet there are no cases of ADC biosimilars having been developed or commercialized to date. The assessment is that Samsung Episholdings, which was spun off from Samsung Biologics, has opened a new path as it transitions into a new drug and biosimilar developer with a focus on ADCs.

According to the bio industry on November 21, Samsung Bioepis's Enhertu biosimilar project has entered the early development stage in preparation for preclinical trials. In addition to this, Samsung Bioepis is developing biosimilars for ten products, including Keytruda-the world's leading anticancer drug-Dupixent (for dermatitis), Tremfya (for psoriasis), and Taltz (for psoriasis).

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Enhertu is an ADC anticancer drug jointly developed by Daiichi Sankyo of Japan and AstraZeneca of the United Kingdom. Since its launch in 2019, sales have surged, and this year, its global sales are expected to exceed 10 trillion won, making it a blockbuster product. It has been called a 'game changer' due to its excellent response rates even among patients who did not respond to conventional HER2 (human epidermal growth factor receptor 2)-targeted ADC therapies, and its indications are rapidly expanding to various solid tumors such as breast, gastric, and lung cancers. The patent is expected to expire in 2033. To date, there have been no cases of ADCs being developed or commercialized as biosimilars in major markets such as the United States and Europe. This is because the complex structure-comprising an antibody, linker, and cytotoxic payload-and the high level of manufacturing difficulty make it especially challenging to prove equivalence.

Unlike conventional antibody drug biosimilars, ADC biosimilars are subject to much stricter manufacturing and quality regulations. Not only must the antibody, linker, and drug-to-antibody ratio (DAR) be precisely reproduced, but the safe manufacturing and purification of the cytotoxic drug must also be ensured. Samsung Bioepis has accumulated know-how through more than 17 global clinical programs, participation in over 30 countries, more than 500 clinical sites, and experience with review and approval procedures from major regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). It is considered one of the handful of bio companies capable of leading the commercialization of ADC biosimilars.

This project is directly aligned with the strategic direction of the recently launched Samsung Episholdings. Samsung Group has separated Samsung Biologics, which focuses on CDMO, from Samsung Bioepis, which focuses on biosimilar and new drug development, and has declared its intention to establish Samsung Episholdings as an 'investment-type holding company' model. The core axis of this holding company model is ADCs. ADCs are a technology that delivers highly potent cytotoxic drugs precisely to cancer cells by conjugating them to antibodies. They are attracting attention because they can maximize therapeutic effects while greatly reducing systemic toxicity compared to conventional anticancer drugs.

According to market research firm Research and Markets, the ADC therapeutics market is expected to more than double in size over the next four years, with a compound annual growth rate (CAGR) of 23.1%. The global ADC market is estimated to be worth about 16.5 billion dollars (approximately 24 trillion won) in 2025, and is projected to reach about 37.9 billion dollars (approximately 55 trillion won) by 2029.

Samsung Episholdings has presented securing next-generation modalities such as ADCs, bispecific antibodies, and peptides as its future strategy, and is rapidly expanding new drug development collaborations with domestic and international platform technology companies such as IntoCell, Proteina, and Frontline. The company's announced plan to submit an ADC IND (Investigational New Drug application) in 2025 and enter Phase 1 clinical trials in 2026 pertains to its new drug development schedule, while the Enhertu project is being carried out simultaneously in its biosimilar business division, which serves as its cash cow.

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At a recent investor relations (IR) event, Samsung Episholdings stated, "In the area of new drug development, we will focus on ADCs, bispecific antibodies, and peptide-based obesity treatments, and pursue a 'Better Strategy' that enhances efficacy and convenience," adding, "Samsung will strengthen its competitiveness through talent and experience, and will fully accelerate its new drug development initiatives."

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