翰宇藥業(300199.SZ):注射用生長抑素通過一致性評價
格隆匯11月5日丨翰宇藥業(300199.SZ)公佈,公司近日通過國家藥監局官方網站獲悉公司的注射用生長抑素通過仿製藥質量和療效一致性評價,注射用生長抑素一致性評價獲批文件(受理號:CYHB1950191國)在國家藥監局網站的辦理狀態變更為“藥品批准證明文件待領取”,簽發日期2021年11月2日。
“藥品批准證明文件待領取”狀態表示公司注射用生長抑素一致性評價已通過國家藥監局批准,目前公司尚未收到正式藥品批件。
注射用生長素抑適應症嚴重急性食道靜脈曲張出血。嚴重急性胃或十二指腸潰瘍出血,或併發急性糜爛性胃炎或出血性胃炎。胰、膽和腸瘻的輔助治療。胰腺術後併發症的預防和治療。糖尿病酮症酸中毒的輔助治療。
注射用生長抑素系全國首家通過一致性評價。截止目前,公司已有貝縮宮素注射液、注射用胸腺法新、依替巴肽注射液、注射用生長抑素後第4個多肽產品通過一致性評價。公司在多肽原料藥及製劑研發、註冊、產業化方面具有較強的競爭力。
公司表示,該次一致性評價通過,有利於提升公司品牌和市場競爭力,為公司的市場開拓帶來積極影響。
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