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恆瑞醫藥(600276.SH):子公司獲得“SHR0302鹼軟膏”臨牀試驗通知書
格隆匯 07-02 17:07

格隆匯 7 月 2日丨恆瑞醫藥(600276.SH)公佈,江蘇恆瑞醫藥股份有限公司(以下簡稱“公司”)子公司瑞石生物醫藥有限公司近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《臨牀試驗通知書》。

藥品基本情況

藥品名稱:SHR0302鹼軟膏

劑型:軟膏劑

規格:0.5%(15g:75mg);1%(15g:150mg);2%(15g:300mg)

註冊分類:化學藥品1類

申請人:瑞石生物醫藥有限公司

受理號:CXHL2000155;CXHL2000156;CXHL2000157

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年4月9日受理的SHR0302鹼軟膏符合藥品註冊的有關要求,同意按照提交的方案開展本品擬用於白癜風的治療的臨牀試驗。

2020年4月9日,瑞石生物醫藥有限公司向國家藥品監督管理局遞交的臨牀試驗申請獲受理。SHR0302鹼是一種小分子JAK1激酶選擇性抑制劑,擬適用於白癜風的治療。

經查詢,國內外尚無JAK抑制劑獲批用於白癜風的治療。在全球,目前已有多個JAK抑制劑針對白癜風適應症開展臨牀研究,其中Incyte公司的蘆可替尼(Ruxolitinib)已進入III期臨牀研究。

截至目前,SHR0302項目的累計已投入研發費用約為17,378萬元人民幣。

根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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