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信達生物(01801.HK):將同禮來繼續配合FDA完成上市審評
信達生物(01801.HK)表示,ORIENT-11試驗結果數據展示了信迪利單抗的良好的風險獲益關係。並且,美國食品藥物管理局(FDA)沒有任何對於信迪利單抗安全性和有效性問題的質疑。信達生物對信迪利單抗的臨牀和商業化價值一如既往充滿信心,將同禮來繼續與FDA配合完成新藥上市申請的審評工作。 根據FDA日前召開的腫瘤藥物諮詢委員會(ODAC)會議,最終以14:1的投票結果,認爲禮來公司(LLY.US)與其中國合作夥伴信達生物開發的抗癌藥PD-1抗體信迪利單抗Tyvyt應補充臨牀試驗,證明其在美國人羣和美國醫療實踐中的適用性才能獲得上市批準。
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