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藥品審批進程提速利好CRO及在研儲備豐富的醫藥公司

10月8日中國政府發佈《關於深化審評審批制度改革鼓勵藥品醫療器械創新的意見》,值得關注的政策有如下幾點。首先,臨床試驗申請的備案制,這可能會縮短臨床試驗申請批准時間,有利於研發儲備豐富的公司以及提供研究服務的機構。

二是鼓勵藥品和醫療器械的研發,收緊對新藥品和器械的審查和批准的規則。我們認為整體行業監管日趨嚴格,有利於研發實力雄厚、研發儲備豐富的醫藥生產企業及醫療器械製造公司。

我們建議關注泰格醫藥(300347.SZ)、石藥集團(1093.HK)。泰格醫藥是中國CRO領域的龍頭,為國內外醫藥及健康產品的研發提供臨床研究服務,有望受益於藥品審批改革帶來的產業增量。公司在中國擁有60家研究中心,廣泛的網路覆蓋有利於公司承接更多訂單。石藥集團的以恩必普為代表的創新藥銷售強勁增長,產品線不斷豐富,在研產品支援未來增長。隨著銷售網路擴張,石藥集團的業務覆蓋更多城市和醫院。

撰稿: 周霖研究分析員
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+852 2277 6515

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