恆瑞醫藥(600276.SH):創新藥SHR0302片獲批臨牀
格隆匯5月13日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥監局核准簽發的《臨牀試驗通知書》。藥品名稱:SHR0302片;劑型:片劑;規格:2mg、4mg、8mg(以C18H22N8O2S計);註冊分類:化學藥品1類;受理號:CXHL2000050、CXHL2000051、CXHL2000052。截至目前,該產品累計已投入研發費用約為1.4031億元。
SHR0302是一種小分子JAK1激酶選擇性抑制劑,擬適用於活動性強直性脊柱炎的治療。經查詢,國內外尚無JAK抑制劑獲批用於強直性脊柱炎的治療。在全球,目前已有多個JAK抑制劑針對強直性脊柱炎適應症開展臨牀研究,其中輝瑞公司的託法替布(Tofacitinib)及艾伯維公司的Upadacitinib已進入III期臨牀試驗階段。
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