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恆瑞醫藥(600276.SH):SHR1459片獲得藥物臨牀試驗批准通知書
格隆匯 08-13 18:08

格隆匯 8 月 13日丨恆瑞醫藥(600276.SH)公佈,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核准簽發的《藥物臨牀試驗批准通知書》。

藥品名稱:SHR1459片;劑型:片劑;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:CXHL2000211;CXHL2000212;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5月11日受理的SHR1459片符合藥品註冊的有關要求,同意開展視神經脊髓炎譜系疾病適應症的早期臨牀試驗。

2020年5月11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。SHR1459片擬適用於視神經脊髓炎譜系疾病的治療。經查詢,國內外尚無同類藥物獲批用於視神經脊髓炎譜系疾病的治療。

截至目前,該產品累計已投入研發費用約為6776萬元人民幣。

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