Samsung Group's entry of a new drug into global clinical trials through Samsung Bioepis comes 15 years after the late Chairman Lee Kun-hee designated the bio sector as a "new growth engine business." With this, Samsung Group has completed a vertical integration structure of "new drug development," represented by Samsung Epis Holdings (0126Z0), the parent company of Samsung Bioepis, and "new drug manufacturing," represented by Samsung Biologics. Samsung Epis Holdings is actively pursuing an open innovation strategy to preempt the antibody-drug conjugate (ADC) and obesity treatment sectors, which are attracting high attention in the global new drug market.
'SBE303,' the ADC new drug that Samsung Bioepis is entering into Phase 1 global clinical trials for the first time on the 14th, targets the 'Nectin-4' protein expressed in various solid tumors including bladder cancer, lung cancer, and breast cancer. The preclinical data for SBE303 will be unveiled for the first time at the American Association for Cancer Research (AACR) Annual Meeting held in San Diego, USA, from the 17th to 22nd of this month (local time). According to the abstract released ahead of the on-site poster presentation, SBE303 demonstrated tolerability up to a dose of 40 mg/kg in repeated-dose toxicity studies in monkeys. This is evaluated as demonstrating high potential for therapeutic improvement compared to existing Nectin-4 targeting ADCs.
◇ Global New Drug Clinical Trial 15 Years After 'New Growth Engine Business' Selection = Samsung Group has entered its self-developed new drug into global clinical trials 15 years after Chairman Lee designated bio as a new growth engine business. In 2010, Chairman Lee announced "the businesses and products representing Samsung will all disappear within the next 10 years," and presented five "new growth engine businesses": △solar cells △automotive batteries △light-emitting diodes (LED) △bio pharmaceuticals △medical devices.
Samsung Group's bio business began in earnest with the establishment of Samsung Biologics, a contract development and manufacturing organization (CDMO) for pharmaceuticals, in 2011. The following year in 2012, Samsung Bioepis was launched to develop biosimilars, which carry relatively lower development risks compared to new drugs. When the spin-off of Samsung Epis Holdings, a bio holding company, from Samsung Biologics was decided last year, the pharmaceutical and bio industry evaluated that Samsung Group had revealed its intention for full-scale new drug development following biosimilars. Furthermore, as Samsung Epis Holdings begins full-scale global new drug clinical trials, the vertical integration puzzle of new drug development and manufacturing has been completed.
◇ Active Utilization of 'Open Innovation' Strategy = Samsung Epis Holdings is actively pursuing open innovation as its new drug development strategy. SBE303 is a new drug combining Samsung Bioepis's self-developed antibody, IntoCell's (287840) linker platform, and a payload developed by IntoCell with patent licensing from China's Frontline. Samsung Bioepis is also conducting preclinical development of its second new drug 'SBE313' through open innovation. SBE313 is a bispecific antibody-dual payload ADC being co-developed by Samsung Bioepis and Frontline. This is attracting attention as a next-generation technology that can overcome cancer cell heterogeneity and resistance issues by carrying two different payloads.
Samsung Epis Holdings has also partnered with domestic bio companies in the long-acting obesity treatment sector. Last month, Samsung Bioepis and Epis Nexlab signed a three-party joint research and license agreement with G2G Bio (456160) for obesity treatment development. The core objective is to extend the administration cycle of glucagon-like peptide (GLP)-1 class obesity treatments to several months using G2G Bio's "microsphere-based long-acting drug delivery technology." Epis Nexlab is responsible for joint R&D with G2G Bio to establish a long-acting drug delivery technology platform. The purpose is to secure platform capabilities that can expand to various technologies beyond obesity treatments. With Protina (468530), they announced plans to develop AI-designed antibody new drug candidates, aiming to develop 10 AI-designed antibody new drug candidates within 27 months by the end of 2027.
Accordingly, Samsung Bioepis's R&D investment is also rapidly expanding. According to disclosures from holding company Samsung Epis Holdings, the company's R&D expenditure recorded 151.6 billion won in 2023 and 171.8 billion won in 2024, followed by 247.4 billion won last year, a 44% increase year-over-year. Samsung Bioepis expects R&D expenditure this year to exceed 400 billion won, the highest level in the industry, due to subsequent biosimilar and new drug clinical trial entries. A Samsung Bioepis official said, "The relaxation and simplification of Phase 3 biosimilar systems in the US, Europe, and Korea are serving as opportunities to expand competitive pipelines," adding, "We will pursue sustainable growth based on an R&D strategy that combines biosimilar development and commercialization capabilities with biotech platform business."
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