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泰凌醫藥(01011.HK)“舒思”獲通一致性評價 進鞏固精神科治療市場地位
格隆匯 02-20 20:05

格隆匯2月20日丨泰凌醫藥(01011.HK)公佈,公司附屬公司-蘇州第壹製藥有限公司的一款用於治療雙相感情障礙的複方藥物舒思(通用名:富馬酸奎硫平片)近日經中國國家食品藥品監督管理局批准通過一致性評價。該產品是按照仿製藥品質和療效一致性評價的標準完成生物等效性研究,並且通過與原研藥進行頭對頭對照臨牀試驗的仿製藥,表示該藥品與原研藥的品質和療效一致,可實現原研藥的臨牀替代,能為患者提供優質及優價的用藥選擇。

舒思是蘇州第壹生產的自主產品。2013年12月,舒思獲國家藥監局批准治療雙相感情障礙。作為一種非典型抗精神病藥物,舒思對首發精神病患者、老年患者及青少年患者有可靠的安全性和良好的療效。作為全國醫保、基藥雙目錄藥品,舒思屬於國家批准的處方用藥。該集團旗下自有品牌產品舒思通過一致性評價後,將進一步鞏固集團作為國內精神科治療的市場地位。

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