【复宏汉霖(02696.HK)：HLX02(曲妥珠单抗，美国商品名：HERCESSITM)获美国食品药品管理局(FDA)批准用于乳腺癌辅助治疗、转移性乳腺癌及转移性胃癌治疗】智通财经APP讯，复宏汉霖(02696.

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【复宏汉霖(02696.HK)：HLX02(曲妥珠单抗，美国商品名：HERCESSITM)获美国食品药品管理局(FDA)批准用于乳腺癌辅助治疗、转移性乳腺癌及转移性胃癌治疗】智通财经APP讯，复宏汉霖(02696.HK)发布公告，有关公司与Intas Pharmaceuticals Limited订立一份许可协议，据此，公司同意授予Intas及其附属公司一项独家许可，供其于美国及加拿大商业化...

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HK): HLX02 (trastuzumab, US trade name: HERCESSITM) was approved by the US Food and Drug Administration (FDA) for adjuvant treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer Treatment] Zhitong Finance APP News, Henlius (02696.","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02696":1,"BLA.AU":1},"content_text":"【复宏汉霖(02696.HK)：HLX02(曲妥珠单抗，美国商品名：HERCESSITM)获美国食品药品管理局(FDA)批准用于乳腺癌辅助治疗、转移性乳腺癌及转移性胃癌治疗】智通财经APP讯，复宏汉霖(02696.HK)发布公告，有关公司与Intas Pharmaceuticals \n\nLimited订立一份许可协议，据此，公司同意授予Intas及其附属公司一项独家许可，供其于美国及加拿大商业化HLX02(注射用曲妥珠单抗)。2023年2月，由公司商务合作伙伴Accord \n\nBioPharma \n\nInc.(Intas的附属公司)于美国提交的有关150mg/瓶规格HLX02(注射用曲妥珠单抗)的生物制品许可申请(BLA)获美国食品药品管理局受理。近日，Accord收到FDA的批准函， \n\n150mg/瓶规格HLX02(注射用曲妥珠单抗)获FDA批准用于(1)辅助治疗HER2 \n\n过表达乳腺癌;(2)治疗HER2过表达转移性乳腺癌;及(3)治疗HER2过表达转移性胃腺癌或胃食管交界腺癌，其于美国获批的商品名为HERCESSITM。据此，HLX02(注射用曲妥珠单抗)成为公司首个获FDA批准于美国上市的产品。","kind":null,"is_publish_news":false,"is_publish_highlight":false,"is_publish_live":true,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.29.0","shortVersion":"4.29.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2430987213"}