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恩華藥業(002262.SZ):許可方TRV-130注射液上市申請已獲得FDA批准
格隆匯 08-10 15:55

格隆匯 8 月 10日丨恩華藥業(002262.SZ)公佈,公司與美國Trevena公司(“Trevena”)於20184月底簽署了關於1類化學藥品TRV-130注射液中國開展“授權適應症”獨家許可開發與商業化合作協議近日協議許可方Trevena收到美國食品藥品監督管(FDA)的通知,其申報的TRV-130注射液新藥上市申請已獲得批准

TRV-130一種新型小分子G蛋白偏向性配體,作用於μ-阿片受體(MOR),擬開發用於治療需要靜脈注射阿片類藥物的成人患者的中度至重度急性疼痛,曾被美國FDA授予突破性療法認定

TRV-130是由Trevena在美國發現和開發的,公司擁有TRV-130在中國開發和商業化的獨家許可權利公司現已獲得國家食品藥品監督管理批准在中國開展TRV-130注射液臨牀試驗該產品在美國的獲批,將有助於加快其在中國的臨牀試驗進程。臨牀試驗完成後,公司將申報產品的生產批件。該產品的獲批生產將進一步豐富公司精神類及麻醉類藥品的產品

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