上海醫藥(601607.SH)：鹽酸貝那普利片及鹽酸度洛西汀腸溶膠囊通過仿製藥一致性評價
格隆匯 12 月 2日丨上海醫藥(601607.SH)公佈，近日，公司控股子公司上海新亞藥業閔行有限公司(“新亞閔行”)及上海上藥中西製藥有限公司(“上藥中西”)分別收到國家藥品監督管理局(“國家藥監局”)頒發的關於鹽酸貝那普利片及鹽酸度洛西汀腸溶膠囊的《藥品補充申請批准通知書》(通知書編號分別為：2020B05031及2020B05032)。
鹽酸貝那普利片；劑型：片劑；規格：10mg；註冊分類：化學藥品；申請人：上海新亞藥業閔行有限公司；原批准文號：國藥準字H20044840；審批結論：本品通過仿製藥質量和療效一致性評價。
鹽酸度洛西汀腸溶膠囊；商品名稱：奧思平；劑型：膠囊劑；規格：20mg；註冊分類：化學藥品；申請人：上海上藥中西製藥有限公司；原批准文號：國藥準字H20061263；審批結論：本品通過仿製藥質量和療效一致性評價。
鹽酸貝那普利片主要用於治療高血壓，充血性心力衰竭，作為對洋地黃和/或利尿劑反應不佳的充血性心力衰竭病人(NYHA分級II-IV)的輔助治療，由瑞士諾華製藥公司研發，最早於1990年在歐洲上市。2020年1月，新亞閔行就鹽酸貝那普利片仿製藥一致性評價向國家藥監局提出申請並獲受理。截至公告日，公司針對鹽酸貝那普利片的一致性評價已投入研發費用約人民幣(下同)1110萬元。
鹽酸度洛西汀腸溶膠囊主要用於治療抑鬱症等，由美國禮來公司研發，於2004年在美國上市。2019年2月，上藥中西就鹽酸度洛西汀腸溶膠囊仿製藥一致性評價向國家藥監局提出申請並獲受理。截至公告日，公司針對鹽酸度洛西汀腸溶膠囊的一致性評價已投入研發費用約726萬元。
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及醫療機構採購等領域將獲得更大的支持力度。因此鹽酸貝那普利片及鹽酸度洛西汀腸溶膠囊通過仿製藥一致性評價，有利於擴大其市場份額，提升市場競爭力，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。
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