人福醫藥(600079.SH):合作研發項目白熱斯丸獲得藥物臨牀試驗批准通知書
格隆匯1月12日丨人福醫藥(600079.SH)公佈,公司全資子公司武漢人福創新藥物研發中心有限公司(“人福研發中心”)與新疆維吾爾自治區維吾爾醫藥研究所合作研發項目白熱斯丸於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》。
白熱斯丸源於《新疆維吾爾自治區維吾爾醫醫療機構製劑標準》收載的院內製劑,按照中藥註冊分類第1.1類中藥創新藥要求申請臨牀試驗,擬用於穩定期白癜風的治療。目前臨牀上主要使用鈣調神經磷酸酶抑制劑、維生素D3衍生物及激素類藥物治療白癜風,公司未能從公開渠道獲知白癜風病患、用藥等市場規模數據。
白熱斯丸是人福研發中心與新疆維吾爾自治區維吾爾醫藥研究所合作研發項目,人福研發中心將按里程碑合計支付給新疆維吾爾自治區維吾爾醫藥研究所600萬元人民幣,白熱斯丸相關技術及其知識產權的所有權和處置權歸人福研發中心所有,截至目前該項目累計研發投入為240萬元人民幣。
根據我國藥品註冊相關的法律法規要求,人福研發中心和新疆維吾爾自治區維吾爾醫藥研究所在收到上述藥物臨牀試驗通知書後,將着手啟動藥物的臨牀研究相關工作,待完成臨牀研究後,將向國家藥品監督管理局遞交臨牀試驗數據及相關資料,申報生產上市。
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