Samsung Bioepis Advances First Novel ADC Targeting Nectin-4 into Phase 1 Trials Following FDA Clearance
核心洞察
Samsung Bioepis (搜索) received FDA investigational new drug clearance in December 2025 for SBE303 (搜索), its first novel antibody-drug conjugate targeting Nectin-4 (搜索) for solid tumors (搜索).
The company plans to initiate Phase 1 first-in-human clinical trials for SBE303 (搜索) in both the United States and Korea this year to evaluate safety and efficacy in advanced refractory solid tumors (搜索).
Samsung Epis Holdings (搜索) announced an ambitious expansion plan to secure 20 biosimilars by 2030, adding six new candidates including dupilumab, vedolizumab, and ocrelizumab to its pipeline.
Samsung Bioepis (搜索) has received FDA investigational new drug (IND) clearance for SBE303 (搜索), marking a significant milestone as the company's first novel antibody-drug conjugate (ADC) enters clinical development. The FDA granted clearance in December 2025 for the Nectin-4 (搜索)-targeted therapy, which is designed to treat solid tumors (搜索) including urothelial cancer (搜索), lung cancer (搜索), and breast cancer (搜索).
Novel ADC Targets Nectin-4 Protein
SBE303 (搜索) is engineered to bind to Nectin-4 (搜索), an adhesion protein specifically expressed in tumor cells. Nectin-4 plays a crucial role in cell adhesion and is highly expressed on the surface of urothelial carcinoma cells, making it a key biomarker for targeted cancer therapies. The Phase 1 first-in-human clinical trial will evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors (搜索).
"We have received IND approval from the U.S. Food and Drug Administration and plan to initiate Phase 1 clinical trials in both the United States and Korea this year," said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings (搜索), during the 44th J.P. Morgan Healthcare Conference.
Ambitious Pipeline Expansion Strategy
Samsung Epis Holdings (搜索) announced plans to secure 20 biosimilars in its portfolio by 2030, representing a significant expansion from its current lineup of 11 biosimilar drugs available in more than 40 countries. The company is developing six additional biosimilar candidates, including dupilumab (Dupixent), guselkumab (Tremfya), ixekizumab (Taltz), fam-trastuzumab deruxtecan-nxki (Enhertu), vedolizumab (Entyvio), and ocrelizumab (Ocrevus).
"We will aggressively expand the biosimilar portfolio by 2030. To achieve this goal, we are developing six additional candidates in our biosimilar pipeline," Kim stated at the healthcare conference.
The company currently has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, adding to its existing portfolio that includes Adalloce (搜索) for inflammatory conditions and Obodence for osteoporosis and other bone-related diseases.
Transition to Novel Drug Development
Samsung Bioepis (搜索) plans to advance one novel therapeutic candidate into clinical studies annually, leveraging its accumulated expertise from biosimilar development. The company will apply research capabilities, process development expertise, and clinical medicine experience gained through biosimilar development to novel drug discovery.
"As we broaden our portfolio beyond biosimilars, we will continue our development efforts in ADCs, leveraging our innovative R&D platform to expand viable treatment options for patients with unmet needs," Kim explained.
Strategic Innovation Approach
The company's approach to novel drug development combines open innovation with Samsung's healthcare ecosystem. Samsung Bioepis (搜索) is building AI infrastructure to improve internal work efficiency and accelerate drug screening processes. The company is using AI to predict protein structures and identify better antibody candidates through partnerships, including a government-funded AI-driven drug development project with Proteina and Seoul National University.
Samsung Epis Holdings (搜索) has also established Epis NexLab (搜索) as a subsidiary focused on developing next-generation biotechnology platforms, particularly peptide-based drug delivery systems. This expansion reflects the company's commitment to transforming from a biosimilar developer into a comprehensive biopharmaceutical company.
"New drug development is a longer-term industry compared to biosimilars. Rather than chasing short-term results or simply increasing the number of pipelines, we will grow into a comprehensive biopharmaceutical company that builds market trust through rigorous scientific validation," Kim noted.