海正藥業(600267.SH):HS269片獲批藥物臨牀試驗
格隆匯6月25日丨海正藥業(600267.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的HS269片(10mg、50mg、200mg)的《藥物臨牀試驗批准通知書》。
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,2021年4月22日受理的HS269片符合藥品註冊的有關要求,同意按照提交的方案開展臨牀試驗。
HS269是一種口服的RET選擇性抑制劑,HS269片主要適用於治療RET融合陽性的非小細胞肺癌,甲狀腺癌和RET突變陽性的髓樣甲狀腺癌等實體瘤。目前禮來旗下LoxoOncology公司開發的RET抑制劑Selpercatinib(LOXO-292,商品名Retevmo)和BluePrintMedicines公司開發的RET抑制劑Pralsetinib(BLU-667,商品名Gavreto)已在美國獲批上市,國內基石藥業通過引進BluePrintMedicines公司的Pralsetinib,已在2021年3月獲得中國國家藥監局批准用於治療RET融合陽性的非小細胞肺癌。經查詢IMS數據庫,同靶點藥物2020年度國際市場銷售額約為2,597.53萬美元;2021年1-3月國際市場銷售額約為1,736.59萬美元。國內市場暫未查到相關銷售數據。
2021年4月,公司向國家藥監局提交該藥品臨牀註冊申請獲得藥品審評中心正式受理。後續公司將按照上述《藥物臨牀試驗批准通知書》要求進行本品臨牀試驗研究。截至目前,公司在該藥品研發項目上已投入約2,934.25萬元人民幣。
根據我國藥品註冊相關的法律法規要求,藥物在獲得《藥物臨牀試驗批准通知書》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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