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第二项!复星医药MEK1/2抑制剂新适应症拟纳入突破性治疗品种

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7月17日,中国国家药监局药品审评中心(CDE)官网公示,复星医药MEK1/2抑制剂FCN-159片拟纳入突破性治疗品种,拟定适应症为:无法手术或术后残留/复发的NF1相关的丛状神经纤维瘤成人患者。公开资料显示,这也是继组织细胞肿瘤适应症之后,FCN-159第二次被CDE拟纳入突破性治疗品种。https://mp.weixin.qq.com/s?__biz=MzIxOTAxMTQzMQ==&mid=2247492178&idx=1&sn=40b92312cf68f80f8caa855978314b3b&chksm=97e3625aa094eb4cf4e2cd0fece7cfcd01a75f3d83df502809de4e7abb2ef6e8fe26e16428da&scene=90&subscene=93&sessionid=1689762797&flutter_pos=0&clicktime=1689762806&enterid=1689762806&ascene=56&fasttmpl_type=0&fasttmpl_fullversion=6773986-zh_CN-zip&fasttmpl_flag=0&realreporttime=1689762806658&devicetype=android-29&version=28002656&nettype=WIFI&abtest_cookie=AAACAA%3D%3D&lang=zh_CN&session_us=gh_c9b0deb322ab&countrycode=CN&exportkey=n_ChQIAhIQ0IHDKblKsKGH3sbEIk8IcxLrAQIE97dBBAEAAAAAAFbUI5iszwIAAAAOpnltbLcz9gKNyK89dVj0uq%2FTbwWY%2FAbbvwv8ApBRRolNekpyRjTKJ2tdB8A97BEMNWdMxd2rJDC4q7k8LJ%2BgKfrPq4QwLhyzg8aB3%2BkGBmitr8OcQYtSONi58k3TAaxxgjy80u9nqVVDwJ5xwGjCA%2FHB6jTbCtg6%2FtfxkyExit%2FDks5H2WoavMnxg32vH6YwEdDtvdrHQh9q0RsuHCIeHtDcIVb%2BiQO3nC3T0blpUXmAaKONkHd7J%2B3T0nyIB2fm4D1LpjS0TY%2BV9mYoR3GF46FhMaE%3D&pass_ticket=rdDoDQo7yp%2FnKmj3R6rL6NffuVSuZN4ubpIc5St7xwah7bmmhK8uFjoXKMY%2BgKYa&wx_header=3


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