《大行報告》中金:國家藥監局提升抗腫瘤藥臨床研發標準 料龍頭公司長期受益
中金發表報告,指國家藥品監督管理局藥品審評中心發布《以臨床價值為導向的抗腫瘤藥物臨床研發指導原則》(徵求意見稿),是對2017年美國FDA以及2020年ICH(國際人用藥品註冊技術協調會)相關藥物臨床開發指導原則的呼應。
中金指,原則明確提出臨床研究應以患者需求為導向,對機制研究、精準化治療、治療需求的動態變化、藥物安全性、治療體驗和便利性5個角度提出更高要求。 總體而言,該指導原則鼓勵在進一步提高腫瘤藥物有效性,改善安全性的基礎上,深入挖掘瞭解患者的需求,引導藥物研發,並將各項要求明細化,將進一步促進國內腫瘤藥物臨床研究的規範化,為進一步與發達國家臨床標準接軌打下堅實基礎。
而原則第一次明確提出,當選擇陽性藥物作為對照組時,「應盡量為受試者提供臨床實踐中最佳治療方式/藥,而不應為提高臨床試驗成功率和試驗效率,選擇安全有效性不確定,或已被更優的藥物所替代的治療手段。」,「當有最佳支持治療時,應優先選擇其作為對照,而非安慰劑」,引發市場高度關注。 中金認為,長遠有助於鼓勵有臨床價值的真創新,減少同質化競爭,為國內新藥開發在更高層次上參與全球市場上的競爭做出引導。
中金認為,對創新藥產業鏈的要求進一步提升,頭部公司長期受益。文件的推出有助於資源進一步向優質創新藥企及頭部CXO(醫藥外包)公司集中。對於創新藥企來說,藥物開發高效或具備BIC潛力優質品種的企業將得到更多關注。對於CXO公司來講,國內業務佔比較高的公司可能短期業績將會受到一定衝擊,長期來看,國內CXO公司將受益於創新藥整體產業。
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