Samsung Bioepis advances first new drug SBE303 into global Phase 1 trial

Samsung Bioepis plans to advance SBE303 into global Phase 1 clinical trials within the first half, marking 15 years after Samsung Group designated biotechnology as a "new growth engine." SBE303 is the first new drug candidate independently developed by Samsung Epis Holdings and targets Nectin-4 expressed in various solid tumors including bladder, lung, and breast cancers, with the initial indication being bladder cancer.

Preclinical data for SBE303 will be unveiled for the first time at the American Association for Cancer Research Annual Meeting in San Diego from April 17-22. According to the abstract released ahead of the poster presentation, SBE303 demonstrated tolerability up to 40 mg/kg in repeated-dose toxicity studies in monkeys.

SBE303 is a new drug combining Samsung Bioepis's proprietary antibody, IntoCell's linker platform, and a payload developed by IntoCell under a patent license from China's Frontline. The first outcome of the research collaboration agreement signed in December 2023 has entered the clinical stage, and the definitive agreement is scheduled to be signed simultaneously with Phase 1 entry, with detailed terms being fine-tuned.

The research collaboration agreement includes a development option clause under which Samsung Bioepis chooses whether to sign a definitive agreement for a target derived through joint research. If the option is exercised, Samsung Bioepis acquires the development and commercialization rights, and up to five targets are eligible.

Samsung Epis Holdings is also conducting preclinical development of its second drug, SBE313, a bispecific antibody-dual payload ADC being co-developed with Frontline. The company has also partnered with domestic biotech companies in long-acting obesity treatment development and announced plans to collaborate on AI-powered antibody drug development, aiming to develop 10 AI-designed antibody drug candidates within 27 months by the end of 2027.

According to disclosures from Samsung Epis Holdings, R&D expenditure reached 151.6 billion won in 2023 and 171.8 billion won in 2024, before rising 44% year-on-year to 247.4 billion won last year. Samsung Bioepis projects R&D spending will reach over 400 billion won this year, driven by follow-up biosimilar development and new drug clinical trial entries.