我武生物(300357.SZ):終止處於臨牀試驗階段的“塵蟎合劑”項目
格隆匯11月29日丨我武生物(300357.SZ)公佈,日前,公司研發的“塵蟎合劑”完成了“舌下含服塵蟎合劑用於治療變應性鼻炎的臨牀療效及安全性評價——多中心、隨機、雙盲、多劑量、安慰劑平行對照的臨牀試驗”(簡稱“塵蟎合劑II期臨牀試驗”),並形成了《塵蟎合劑II期臨牀試驗總結報吿》。
“塵蟎合劑”為公司研發的,臨牀上用於塵蟎過敏引起的變應性鼻炎等過敏性疾病的脱敏治療,其活性成分為粉塵蟎與屋塵蟎變應原蛋白,給藥方式為舌下含服,劑型為滴劑(液體劑型),目前未有其他企業取得該品種在國內的上市許可。
本品開發之初的定位為公司已上市產品“粉塵蟎滴劑”(國藥準字S20060012)的升級產品。考慮到目前脱敏治療產品正在向固體劑型發展,固體劑型具有攜帶方便、給藥量準等優勢。公司正在開發塵蟎類膜劑(固體劑型)新型脱敏產品,目前處於臨牀前研究階段,預計2023年提出新藥臨牀許可申請。
經公司審慎考慮“塵蟎合劑”後續研發的投入、項目必要性、公司現有研發管線佈局等因素,為合理配置公司現有研發資源,聚焦管線中的優勢項目,決定終止“塵蟎合劑”研發項目,全力推進塵蟎類膜劑(固體劑型)脱敏產品的臨牀前研究,爭取該項目早日進入臨牀試驗。
公司表示,終止處於臨牀試驗階段的“塵蟎合劑”項目,可以更加有效整合公司現有研發資源,全力推進塵蟎類膜劑(固體劑型)脱敏產品早日進入臨牀試驗。
截至該公吿披露日,公司“塵蟎合劑”項目累計開發支出餘額為1391.64萬元,按照《企業會計準則》及公司相關財務會計制度的規定,公司對“塵蟎合劑”項目開發支出進行減值測試後全額計提減值準備1391.64萬元。上述事項將減少公司2022年度利潤總額1391.64萬元。(上述數據未經審計)
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