振東製藥(300158.SZ):多發性硬化症新藥ZD03一期臨牀試驗完成8例受試者給藥
格隆匯11月12日丨振東製藥(300158.SZ)公佈,公司下屬子公司山西振東先導生物科技有限公司自主研發的治療多發性硬化症的1類創新藥ZD03的Ⅰ期臨牀試驗於2019年11月9日在美國順利開展,並完成了8例受試者給藥觀察。
多發性硬化症(Multiple Sclerosis,MS)是一種免疫介導的中樞神經系統慢性炎性脱髓鞘疾病,好發於視神經、脊髓和腦幹,常見的臨牀症狀包括視力下降、複視、肢體感覺障礙、肢體運動障礙、共濟失調、膀胱或直腸功能障礙等。由於累及部位廣泛,反覆發作後可最終致殘,甚至致死。MS治療週期長,患者醫療負擔很重,其治療仍然是世界性難題。
ZD03是源於天然產物的全新化學結構的小分子藥物,是公司自主研發、具有核心知識產權的1類創新藥,主要用於多發性硬化症的治療。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的手段。
值得注意的是,新藥研發具有周期長、風險大、投入高的特點。ZD03尚需開展系列臨牀研究並經美國藥品審評部門審批通過後方可上市。
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