Samsung ramps up pharma ambitions by advancing first in-house drug

Samsung Group has advanced its first fully self-developed drug candidate into global clinical trials, marking a major milestone in its long-term push into biotechnology.

The move comes 15 years after Chairman Lee Kun-hee identified biopharmaceuticals as a future growth engine, and signals the company's shift away from biosimilars toward original drug development.

The drug candidate, SBE303, developed by Samsung Bioepis, is an antibody-drug conjugate (ADC) targeting the Nectin-4 protein, which is found in several solid tumours, including bladder, lung and breast cancers, as highlighted by South Korean media outlets.

The company is set to begin global Phase 1 clinical trials on April 14 in South Korea and the United States, while preclinical data will be presented for the first time at the American Association for Cancer Research Annual Meeting in San Diego from April 17 to 22.

Samsung’s entry into original drug development traces back to 2010, when Lee warned that “within the next 10 years, the businesses and products that represent Samsung will all disappear,” and outlined five new growth areas: solar cells, automotive batteries, LEDs, biopharmaceuticals and medical devices.

The group formally entered the biotech sector with the creation of Samsung Biologics in 2011, followed by Samsung Bioepis in 2012, which focused on lower-risk biosimilars. The restructuring last year that led to the creation of Samsung Epis Holdings was widely seen as a signal of Samsung’s intent to expand into innovative drug development.

Samsung Epis Holdings is now pursuing an open innovation strategy, targeting fast-growing areas such as ADC therapies and obesity treatments. With the launch of global clinical trials, the group has effectively completed a vertically integrated model spanning drug discovery through to manufacturing.

The company has also been expanding partnerships with domestic biotech firms. Recent agreements include a joint research and licensing deal with G2G Bio on long-acting obesity treatments, as well as a collaboration with Protina to develop AI-designed antibody drugs. The goal is to produce 10 such candidates within 27 months by the end of 2027.

Investment in research and development has surged accordingly. Samsung Bioepis’s R&D spending rose from about $117 million in 2023 to roughly $132 million in 2024, before jumping 44% year-on-year to around $190 million last year. The company expects that figure to exceed $300 million this year, driven by both biosimilar projects and new drug clinical trials.

By Nazrin Sadigova