“2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030,” said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings.

“We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs.”

□ Samsung Bioepis Biosimilar Updates

· Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries.[1] The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030.

· The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.

□ Novel Therapeutics Updates

· In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.[2] The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year.

· Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year.

· Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform.