Samsung Epis Seeks Korean Approval for a Cancer Immunotherapy Biosimilar

MT Newswires Live

Aug 10

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.

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Safety profiles, including treatment-emergent adverse events and serious adverse events, were also similar.</p><p>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.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4504","symbol_name":"桥水持仓","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2658821839","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2658821839","pubTimestamp":1786355535,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. 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