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翰宇藥業(300199.SZ):注射用特利加壓素通過仿製藥一致性評價
格隆匯 12-28 17:42

格隆匯12月28日丨翰宇藥業(300199.SZ)公佈,公司近日通過國家藥品監督管理局(以下簡稱“國家藥監局”)官方網站獲悉公司的注射用特利加壓素通過了仿製藥質量和療效的一致性評價,注射用特利加壓素一致性評價獲批文件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12月22日。“藥品批准證明文件待領取”狀態表示公司注射用特利加壓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。

特利加壓素的適應症:注射用特利加壓素主要用於肝硬化靜脈曲張出血的止血,臨牀廣泛應用於肝腎綜合徵、肝硬化腹水、感染性休克、燒傷、急性肝功能衰竭、心臟驟停等的治療,被中華醫學會《肝硬化食管胃鏡脈曲張出血防治指南》、EASL《肝硬化腹水,自發性細菌性腹膜炎,肝腎綜合徵處理指南》等推薦為一線治療方法。

繼卡貝縮宮素注射液、注射用胸腺法新、依替巴肽注射液、注射用生長抑素之後,注射用特利加壓素通過一致性評價,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。2009年,公司注射用特利加壓素為首仿上市,本次為全國首家通過一致性評價。

2017年,中華醫學會外科學分會發布的《肝切除術後加速康復中國專家共識》推薦特利加壓素作為術後腹腔積液防治的一線用藥,極大肯定了特利加壓素在臨牀應用的拓展。我國作為肝炎高發國家,肝硬化、肝腹水的發病率一直呈高發態勢,隨着臨牀接受度的提高以及治療科室的拓展,特利加壓素在臨牀獲得了更多應用機會。

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