奧賽康(002755.SZ):簽署泊沙康唑腸溶片(100 mg)獨家銷售和推廣協議
格隆匯1月17日丨奧賽康(002755.SZ)公佈,2019年12月12日,公司的子公司江蘇奧賽康藥業有限公司(“江蘇奧賽康”)與上海宣泰醫藥科技有限公司(“上海宣泰”)簽署了《關於泊沙康唑腸溶片產品獨家代理銷售事宜的合作意向書》。
2020年1月16日,江蘇奧賽康、嘉信景天與上海宣泰簽署了《泊沙康唑腸溶片(100 mg)獨家銷售和推廣協議》。上海宣泰將擁有的泊沙康唑腸溶片(產品規格:100mg片)在中國大陸地區(即中華人民共和國除香港特別行政區、澳門特別行政區及台灣以外的區域,“代理區域”)的獨家推廣權授權江蘇奧賽康,將獨家銷售權授權嘉信景天。
產品獲批適應症:用於預防侵襲性麴黴和念珠菌感染,適用於因免疫系統嚴重受損的患者,免疫系統嚴重受損包括造血幹細胞移植(HSCT) 接受者患有的移植物抗宿主病(GVHD) 或惡性血液病患者因化療而導致長期的中性粒細胞減少。
泊沙康唑腸溶片被列入國家發佈的《第一批鼓勵仿製藥品目錄建議清單》,作為新一代三唑類抗真菌藥,泊沙康唑腸溶片用於預防侵襲性麴黴和念珠菌感染,適用於因免疫系統嚴重受損的患者,免疫系統嚴重受損包括造血幹細胞移植(HSCT) 接受者患有的移植物抗宿主病(GVHD) 或惡性血液病患者因化療而導致長期的中性粒細胞減少。隨着癌症化療、移植、HIV/AIDS感染以及糖尿病等高風險患者數量的不斷增多,侵襲性真菌感染(IFI)的總髮病率不斷攀升,一旦被感染,死亡率高達60%以上,泊沙康唑用於侵襲性真菌感染的預防具有區別於其它藥物的治療優勢。與口服混懸液相比,腸溶片能夠進一步提高口服生物利用度,使抗真菌效果更好得以發揮,服用也更加便捷,市場前景廣闊。
目前上海宣泰的泊沙康唑腸溶片已於2019年8月21號獲得美國FDA(美國食品藥品監督管理局)的ANDA(仿製藥申請)批准,在美國上市銷售。並且於2019年2月19日在國內報產,2019年9月16日進入優先審評名單,是國內獨家完成生物等效性實驗,首家申報生產的泊沙康唑腸溶片,預計2020年能夠順利上市。
江蘇奧賽康研發的泊沙康唑注射液預計將於2020年國內首家上市,注射用多粘菌素E甲磺酸鈉、注射用達託黴素、注射用伏立康唑等產品已經提交國家藥品監督管理局藥品審評中心報產等待審批,泊沙康唑腸溶片的上市將配合公司的產品佈局,進一步鞏固公司在耐藥菌感染領域的地位,產生新的經濟增長點。
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