復星醫藥(02196.HK):氨甲環酸注射液用於治療全身性纖維蛋白溶解亢進所致的出血及局部纖維蛋白溶解亢進所致的異常出血獲國家藥監局藥品註冊申請審評受理
格隆匯1月6日丨復星醫藥(02196.HK)公吿,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司錦州奧鴻藥業有限責任公司(以下簡稱“奧鴻藥業”)研製的氨甲環酸注射液(以下簡稱“該新藥”)用於治療全身性纖維蛋白溶解亢進所致的出血及局部纖維蛋白溶解亢進所致的異常出血獲國家藥品監督管理局(以下簡稱“國家藥監局”)藥品註冊申請審評受理。
該新藥為奧鴻藥業自主研發的化學藥品,擬主要用於:(1)全身性纖維蛋白溶解亢進所致的出血,如白血病、再生障礙性貧血、紫癜等,以及手術中和手術後的異常出血;(2)局部纖維蛋白溶解亢進所致的異常出血,如肺出血、鼻出血、生殖器出血、腎出血、前列腺手術中和術後的異常出血。
截至本公吿日,於中國境內(不包括港澳台,下同)獲批上市的氨甲環酸注射液主要包括山西普德藥業有限公司的妥塞敏、貴州聖濟堂製藥有限公司的聖濟寧、湖南洞庭藥業股份有限公司的速寧等。根據IQVIACHPA最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商;IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2020年度,氨甲環酸注射液於中國境內銷售額約為人民幣6.73億元。
截至2021年11月,奧鴻藥業現階段針對該新藥累計研發投入約為人民幣555萬元(未經審計)。
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