信達生物(01801.HK)撤回治療淋巴瘤藥物新藥上市許可申請
信達生物(01801.HK)公布,有關早前向國家藥監局遞交帕薩利司片(研發代號:IBI-376)的新藥上市許可申請(NDA),用於治療既往接受過至少兩種系統性治療的復發或難治性濾泡性淋巴瘤(FL)的成人患者,並於1月獲受理,公司基於整體研發策略和產品價值管理的考量,決定主動撤回帕薩利司片的該項申請,並將資源集中投入在更多重要管線上。
公司指出,在該項申請遞交後,由於合作方對該產品海外開發策略的調整,導致公司後續確證性臨床三期研究的投資大幅增加、研究時間顯著延長。考慮到該產品所申報適應症的患者群體較小、市場競爭較為激烈,撤回該項申請對公司的產品銷售影響非常有限,且對公司的整體投入產出有更正面的作用。
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