華海藥業(600521.SH):鹽酸舍曲林片通過藥品一致性評價
格隆匯2月9日丨華海藥業(600521.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品補充申請批件》,藥品名稱為鹽酸舍曲林片。
鹽酸舍曲林片主要用於治療抑鬱症的相關症狀和強迫症。鹽酸舍曲林片由輝瑞公司研發,最早於1990年12月在英國上市,於1998年2月在國內上市。公司於2016年1月啟動鹽酸舍曲林片的一致性評價工作,於2020年1月15日獲得國家藥監局審核通過。
2018年,公司鹽酸舍曲林片國內銷售收入約6453.39萬元。該藥品國內主要生產廠家有浙江華海藥業股份有限公司、浙江京新藥業股份有限公司、廣州白雲山光華製藥股份有限公司等。據統計,2018年鹽酸舍曲林片國內等級醫院銷售額約7.94億元(數據來源於鹹達數據庫)。截至目前,公司鹽酸舍曲林片項目國內研發申報費用約988萬元。
根據國家相關政策,通過一致性評價的藥品品種,在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用。同品種藥品通過一致性評價的生產企業達到3家及以上的,在藥品集中採購等方面不再選用未通過一致性評價的品種。
因此公司鹽酸舍曲林片通過一致性評價,有利於擴大上述產品的市場銷售,提高市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗,對公司的經營業績產生積極的影響。
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