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山東新華製藥股份(00719.HK):鹽酸苯海拉明片(25mg)通過仿製藥一致性評價
格隆匯 07-29 16:53

格隆匯 7 月 29日丨山東新華製藥股份(00719.HK)發佈公告,近日,公司收到國家藥品監督管理局核准簽發的鹽酸苯海拉明片(25mg)《藥品補充申請批准通知書》,該產品通過仿製藥質量和療效一致性評價。公司成為國內鹽酸苯海拉明片(25mg)第二家通過仿製藥一致性評價的企業。

2019年7月,新華製藥向國家藥品監督管理局藥品審評中心(CDE)遞交鹽酸苯海拉明片(25mg)仿製藥一致性評價註冊申報資料並獲受理。2020年1月CDE發出補充研究通知,2020年5月公司完成補充資料的遞交,2020年7月通過仿製藥質量和療效一致性評價審評審批並獲得《藥品補充申請批准通知書》。

鹽酸苯海拉明片為抗過敏類非處方藥品,是醫保工傷用藥,用於皮膚黏膜的過敏,如蕁麻疹、過敏性鼻炎、皮膚瘙癢症、藥疹,對蟲咬症和接觸性鼻炎也有效;該產品亦可用於預防和治療暈動病,有較強的鎮吐作用。

據米內網數據庫統計,目前中國境內上市的鹽酸苯海拉明片企業55家,申請仿製藥一致性評價的企業有宜昌人福藥業和山東新華製藥2家,目前均已完成審評審批。截至該公告日,公司針對鹽酸苯海拉明片(25mg)的一致性評價已投入研發費用約為人民幣1001.46萬元(未經審計)。

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