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長江生命科技(00775.HK)獲美國食品藥物管理局授予快速通道資格認定
格隆匯 06-23 16:57

格隆匯 6 月 23日丨長江生命科技(00775.HK)發佈公告,有關公司的美國全資附屬公司Polynoma LLC(“Polynoma”)(一間專注於腫瘤免疫學的生物製藥公司)進行研究的黑色素瘤候選疫苗seviprotimut-L第三階段臨牀研究的進展。 美國食品及藥物管理局已批准Polynoma 有關seviprotimut-L的快速通道資格認定(Fast Track designation)申請。

快速通道旨在促進治療嚴重或危及生命情況的藥物開發,同時加快該等藥物的審查,以應付仍未滿足的醫療需求。食品藥物管理局根據多項條件(例如:能夠證明療效卓越或可改善對嚴重後果的影響、避免現有療法所帶來的嚴重副作用、減低現有療法中常見並且會導致中止治療的臨牀顯著毒性,以及有能力解決預期中的公共衞生需求),將應付仍未滿足的醫療需求界定為“提供一種尚未存在的療法,或提供一種相對現有療法可能屬更佳的療法”。

取得快速通道資格認定帶來的裨益包括:可與食品藥物管理局開展更頻繁的溝通、分階段提交新藥推售申請,以及在達致相關條件後,符合優先審評(Priority Review)及加速批准(Accelerated Approval)的資格。

Polynoma認為,獲食品藥物管理局授予快速通道資格認定,進一步確認 seviprotimut-L可望作為侷限性黑色素瘤患者的嶄新重要癌症疫苗。

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