恆瑞醫藥(600276.SH):SHR0302片獲批開展臨牀試驗
格隆匯3月7日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發關於SHR0302片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年12月17日受理的SHR0302片符合藥品註冊的有關要求,同意本品進行成人活動性放射學陰性中軸型脊柱關節炎臨牀試驗。
公吿顯示,SHR0302是一種高選擇性的JAK1抑制劑,可通過抑制JAK1信號傳導發揮抗炎和抑制免疫的生物學效應,臨牀擬用於活動性放射學陰性中軸型脊柱關節炎的治療。經查詢,國內外尚無針對該適應症的同類產品獲批上市。截至目前,SHR0302相關研發項目累計已投入研發費用約41145萬元。
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