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Arthur2007
Arthur2007
·
07-31
$Figma(FIG)$
88/我预测
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Arthur2007
Arthur2007
·
07-30
所以说,能涨不
兆科眼科-B(06622):用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证
智通财经APP讯,兆科眼科-B 发布公告,美国食品药品监督管理局已向公司拥有专利配方、用于治疗儿童视网膜母细胞瘤的美法仑授出孤儿药资格认证。再者,如果美法仑获成功研发并获批准,公司将在新药上市申请批准后享有七年美国市场独家权利。此项完善保护涵盖上市许可持有人地位及数据独家权利,尤其重要的是,即使配方有所创新,FDA亦不得批准任何其他以美法仑为基础的RB适应症产品。
兆科眼科-B(06622):用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证
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Arthur2007
Arthur2007
·
07-30
$特朗普媒体科技集团(DJT)$
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2
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Arthur2007
Arthur2007
·
06-04
梭哈全部梭哈,必须梭哈
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Arthur2007
Arthur2007
·
05-30
老头子🐮
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510
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Arthur2007
Arthur2007
·
05-12
$极氪(ZK)$
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407
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Arthur2007
Arthur2007
·
05-12
$极氪(ZK)$
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Arthur2007
Arthur2007
·
05-10
$极氪(ZK)$
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Arthur2007
Arthur2007
·
05-08
$极氪(ZK)$
坑
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Arthur2007
Arthur2007
·
05-07
$极氪(ZK)$
我28元买的,咋办啊?
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19:10","market":"hk","language":"zh","title":"兆科眼科-B(06622):用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证","url":"https://stock-news.laohu8.com/highlight/detail?id=2555430360","media":"智通财经","summary":"智通财经APP讯,兆科眼科-B 发布公告,美国食品药品监督管理局已向公司拥有专利配方、用于治疗儿童视网膜母细胞瘤的美法仑授出孤儿药资格认证。再者,如果美法仑获成功研发并获批准,公司将在新药上市申请批准后享有七年美国市场独家权利。此项完善保护涵盖上市许可持有人地位及数据独家权利,尤其重要的是,即使配方有所创新,FDA亦不得批准任何其他以美法仑为基础的RB适应症产品。","content":"<html><body><p>智通财经APP讯,<a href=\"https://laohu8.com/S/06622\">兆科眼科-B</a>(06622)发布公告,<a href=\"https://laohu8.com/S/USFD\">美国食品</a>药品监督管理局(FDA)已向公司拥有专利配方、用于治疗儿童视网膜母细胞瘤(RB,一种罕见的儿童眼癌)的美法仑授出孤儿药资格认证(Orphan Drug Designation,ODD)。</p><p>取得ODD为在美国提交新药临床试验申请(新药试验申请)建立清晰的监管路径。再者,如果美法仑获成功研发并获批准,公司将在新药上市申请批准后享有七年美国市场独家权利。此项完善保护涵盖上市许可持有人(marketing authorization holder,MAH)地位及数据独家权利,尤其重要的是,即使配方有所创新,FDA亦不得批准任何其他以美法仑为基础的RB适应症产品。</p></body></html>","source":"stock_zhitongcaijing","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta 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href=http://www.zhitongcaijing.com/content/detail/1323745.html><strong>智通财经</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>智通财经APP讯,兆科眼科-B(06622)发布公告,美国食品药品监督管理局(FDA)已向公司拥有专利配方、用于治疗儿童视网膜母细胞瘤(RB,一种罕见的儿童眼癌)的美法仑授出孤儿药资格认证(Orphan Drug Designation,ODD)。取得ODD为在美国提交新药临床试验申请(新药试验申请)建立清晰的监管路径。再者,如果美法仑获成功研发并获批准,公司将在新药上市申请批准后享有七年美国市场...</p>\n\n<a href=\"http://www.zhitongcaijing.com/content/detail/1323745.html\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"06622":"兆科眼科-B","BK1191":"制药","BK1587":"次新股","BK1574":"生物医药B类股","BK1583":"高瓴概念"},"source_url":"http://www.zhitongcaijing.com/content/detail/1323745.html","is_english":false,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2555430360","content_text":"智通财经APP讯,兆科眼科-B(06622)发布公告,美国食品药品监督管理局(FDA)已向公司拥有专利配方、用于治疗儿童视网膜母细胞瘤(RB,一种罕见的儿童眼癌)的美法仑授出孤儿药资格认证(Orphan Drug 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