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交銀國際:內地藥品法修訂利委托生產 料藥明生物受惠 但加劇研發競爭
阿思達克 08-28 15:24

交銀國際發表報告表示,本周一(26日)內地新修訂的《藥品管理法》表決通過,其中包括第一是將臨床試驗管理由批准制改為默認許可制;第二是建立藥品上市許可持有人制度(MAH):擁有藥品技術的研發機構和生產企業均可通過提出申請獲得藥品註冊證書,並對該藥的全生命周期承擔責任。法案明確,藥品上市許可持有人可委托藥品生產企業生產。

該行表示,目前國內藥品上市許可通常只頒發給有生產許可的藥企,而委托生產面臨多重監管限制,MAH 制度的優勢在於可以讓不具備生產能力的研發機構通過成為持有人及委托生產的方式,將科研成果轉化為市場化產品,以激勵行業創新。

交銀國際稱,新制度的實施將利好於外包生產企業,如藥明生物(02269.HK)(予「買入」評級及目標價100元),但由於加劇了研發競爭,對傳統藥企的研發能力提出更高的要求。該行繼續偏好自主研發能力突出、在研管線豐富的公司,首推買入石藥(01093.HK)(予「買入」評級及目標價19.5元)。

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