振東製藥(300158.SZ):治療多發性硬化症ZD03新藥獲批臨牀
格隆匯8月3日丨振東製藥(300158.SZ)公佈,公司下屬子公司振東先導於2020年5月8號向國家藥品監督管理局遞交了ZD03新藥的IND(Investigational New Drug)申請並獲得受理;近日,振東先導收到國家藥品監督管理局的《藥物臨牀試驗批准通知書》,ZD03新藥獲得臨牀批准。
經國家藥品監督管理局審查,2020年5月8日受理的ZD03膠囊符合藥品註冊的有關要求,同意開展多發性硬化的早期臨牀試驗。
該新藥為公司及其下屬子公司振東先導自主研發的、源於天然產物的全新化學結構類型的小分子藥物,主要用於多發性硬化症(Multiple Sclerosis, MS)的治療。
多發性硬化症是一種免疫介導的中樞神經系統慢性炎性脱髓鞘疾病,歐美地區高加索人種具有高發特點。ZD03與MS的一線用藥富馬酸二甲酯具有相同的作用靶點,但ZD03的選擇性更高,起效劑量更低,從而為MS的臨牀治療提供更有效手段。經查詢globaldata數據庫,富馬酸二甲酯2019年全球銷售額為44.87億美元,同比增長3.8%。
截止該公告日,公司現階段針對ZD03新藥已投入研發費用約為2094萬元人民幣(未經審計)。
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