医药行业日报：PTC小分子SEPIAPTERIN在欧盟获批用于治疗PKU

太平洋证券股份...06-27

报告摘要市场表现：2025 年6 月26 日，医药板块涨跌幅-1.05%，跑输沪深300 指数0.70pct，涨跌幅居申万31 个子行业第29 名。各医药子行业中，血液制品(+0.23%)、体外诊断（-0.19%)、医药流通（-0.26%）表现居前，医疗研发外包（-2.67%)、其他生物制品(-1.80%)、疫苗（-1.12%)表现居后。个股方面，日涨幅榜前3 位分别为华强科技(+19.99%)、...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202506271221359790d33b&s=b><strong>太平洋证券股份...</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>报告摘要市场表现：2025 年6 月26 日，医药板块涨跌幅-1.05%，跑输沪深300 指数0.70pct，涨跌幅居申万31 个子行业第29 名。各医药子行业中，血液制品(+0.23%)、体外诊断（-0.19%)、医药流通（-0.26%）表现居前，医疗研发外包（-2.67%)、其他生物制品(-1.80%)、疫苗（-1.12%)表现居后。个股方面，日涨幅榜前3 位分别为华强科技(+19.99%)、...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN202506271221359790d33b&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2506952410.USD","symbol_name":"BNP PARIBAS CLIMATE IMPACT \"CRH\" (USDHDG) ACC 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Daily: PTC small molecule SEPIAPTERIN approved in the EU for the treatment of PKU","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PTC":1},"content_text":"报告摘要市场表现：2025 年6 月26 日，医药板块涨跌幅-1.05%，跑输沪深300 指数0.70pct，涨跌幅居申万31 个子行业第29 名。各医药子行业中，血液制品(+0.23%)、体外诊断（-0.19%)、医药流通（-0.26%）表现居前，医疗研发外包（-2.67%)、其他生物制品(-1.80%)、疫苗（-1.12%)表现居后。个股方面，日涨幅榜前3 位分别为华强科技(+19.99%)、南模生物(+10.53%)、东方海洋(+9.85%)；跌幅榜前3 位为荣昌生物（-18.36%）、悦康药业(-9.03%)、昂利康（-6.00%)。行业要闻：近日，PTC 宣布，旗下药物Sephience（Sepiapterin）已获欧盟委员会批准，用于治疗所有年龄段、不同严重程度的苯丙酮尿症（PKU）患者。Sepiapterin 是一种天然的BH4 酶辅因子前体，BH4 是苯丙氨酸羟化酶（PAH）发挥作用所必需的关键辅因子。该药通过药理伴侣机制发挥作用，即该药和BH4 分别可与变异型PAH 结合，提升酶活性，涵盖PKU 中常见且对BH4 不敏感的PAH 变异型。该机制可增强错误折叠PAH 酶的构象稳定性，并显著提高细胞内BH4 浓度，从而有效降低血液中的苯丙氨酸（Phe）水平。（来源：PTC，太平洋证券研究院）公司要闻：润都股份（002923）：公司发布公告，近日公司收到FDA 出具的现场检查报告（EIR）。根据该核查报告，公司已顺利通过本次美国FDA 现场检查，为公司进一步开拓美国原料药市场奠定了坚实基础。中美华东（000963）：公司发布公告，子公司中美华东收到国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知书》，由中美华东申报的注射用HDM2020 临床试验申请获得批准。宣泰医药（688247）：公司发布公告，近日收到美国FDA 的通知，公司向美国FDA 申报的恩杂鲁胺片的简略新药申请（ANDA）获得暂时批准，标志着该产品满足了仿制药的所有审评要求。博亚生物（300294）：公司发布公告，公司单采血浆站达拉特旗博雅单采血浆有限公司取得达拉特旗市场监督管理局颁发的《营业执照》，公司将按照相关法律法规及标准要求进行建设，验收合格后开展采浆工作。风险提示：新药研发及上市不及预期；市场竞争加剧风险等。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"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; 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医药行业日报：PTC小分子SEPIAPTERIN在欧盟获批 用于治疗PKU

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医药行业日报：PTC小分子SEPIAPTERIN在欧盟获批用于治疗PKU