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《大行報告》大摩:國藥局升抗腫瘤藥臨床研發標準令成本增 短期存挑戰 長期龍頭受益
摩根士丹利發表報告表示,就中國國家藥品監督管理局藥品審評中心(CDE)上周五(2日)發布新政策,徵求《以臨床價值為導向的抗腫瘤藥物臨床研發指導原則》意見的通知,強調以患者為中心和基於臨床價值的臨床試驗設計方法,指是內地上調對腫瘤學臨床試驗的門檻。

該行指,內地新規提倡在腫瘤試驗中盡可能用最佳支持療法(BSC)代替安慰劑作為對照臂。這將提高內地藥品創新者的門檻,因需要開發與市場上的療法相比真正差異化的療法,而且還要將藥物與昂貴的現有藥物進行比較,此將會提高臨床試驗的成本。

大摩指將CDMO(醫藥製造外包)行業視為一個群體,尤其是藥明生物(02269.HK),是這些更高標準的淨受益者。對於真正的創新者而言,這一變化在各自的藥物類別中設置了更高的准入門檻,使相關公司有可能享受更良好盈利能力。該行指該政策可能對短期需求構成挑戰,但從長遠來看將導致市場整合,並為差異化和技術領先的參與者帶來上行潛力,藥明康德(02359.HK)和藥明康德也有一半以上的利潤來自海外市場,料不會完全受到內地新政策的影響。

大摩予藥明生物「增持」評級,目標價152元。

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