贝达药业(300558.SZ)：盐酸恩沙替尼胶囊临床中心通过美国FDA现场核查

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智通财经APP讯，贝达药业(300558.SZ)发布公告，关于盐酸恩沙替尼胶囊临床中心通过美国FDA现场核查。2024年5月、9月，美国FDA对境内外3家临床中心进行有关恩沙替尼I期和III期研究的现场核查，检查结果以NAI(不需要采取措施)或VAI(自愿采取措施)顺利通过。本次通过美国FDA现场核查，表明恩沙替尼的临床试验数据符合美国FDA的要求。

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