KRX:0126Z0

Samsung Epis Seeks Korean Approval for a Cancer Immunotherapy Biosimilar

Samsung Epis (KRX:0126Z0) filed a marketing application in South Korea for a biosimilar to cancer immunotherapy Keytruda, according to a bourse filing on Monday.The Aug. 7 filing is backed by a phase 3 trial of 555 patients with metastatic non-squamous non-small cell lung cancer, which showed SB27 matched Keytruda in the key measure of 24-week response rate within the set equivalence range. Safety profiles, including treatment-emergent adverse events and serious adverse events, were also similar.The application covers a broad range of indications including melanoma, non-small cell lung cancer, gastric cancer and breast cancer. Additional regulatory approvals in other countries are also being planned.

Samsung EPIS Logs KRW85.8 Billion in Q2 Profit

Samsung EPIS (KRX:0126Z0) recorded an attributable net income of 85.8 billion won for the second quarter of 2026.Sales stood at 391.9 billion won in the three months, according to a Monday filing with the South Korea bourse.The biotechnology company did not provide year-over-year comparisons as the company was established on Nov. 3, 2025.For the first half of 2026, attributable net income and sales reached roughly 185.3 billion won and 845.8 billion won, respectively.

Samsung EPIS' Net Income Slides 14% Quarter on Quarter

Samsung EPIS (KRX:0126Z0) logged an attributable net income of 85.8 billion won for the second quarter, down 14% from the previous three-month period.No year-over-year comparison is available as the biotechnology company was established on Nov. 3, 2025, and did not exist in the prior-year period, according to a Korea Exchange filing on Friday.Revenue fell 13% quarter over quarter to 391.9 billion won for the three months ended June 30 from 453.9 billion won in the three months ended April 1.

Samsung EpiS Unit Signs Cancer Drug Development, Commercialization Deal with IntoCell

Samsung EpiS (KRX:0126Z0) said its unit, Samsung Bioepis, signed a development and commercialization deal with South Korean biotechnology company IntoCell for its cancer therapy candidate SBE303, targeting Nectin-4 protein-expressing solid tumors.The deal finalized on Wednesday is part of a joint research pact signed in December 2023 to discover up to five antibody-drug conjugate candidates, according to a same-day filing with the Korean Exchange.The new deal secures rights to SBE303, currently being evaluated in a global Phase 1 clinical trial targeting 149 patients, with financial terms of the agreement yet to be disclosed.The contract includes development milestone payments tied to clinical progress, regulatory approvals, commercialization milestones, and sales-based royalties.

Nomura Adjusts Samsung Epis' Price Target to KRW600,000 from KRW770,000, Keeps at Buy