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上海凱寶(300039.SZ):痰熱清膠囊增加功能主治臨牀試驗申請獲批
格隆匯 06-02 11:54

格隆匯6月2日丨上海凱寶(300039.SZ)宣佈,近日,公司從國家藥品監督管理局官網中獲知:公司痰熱清膠囊增加功能主治的申請獲得了《藥物臨牀試驗批准通知書》,同意進行臨牀試驗。

申請內容:在原“清熱,化痰,解毒。用於風温肺熱病屬風熱襲肺證,症見發熱,惡風,咳嗽,咯痰,或咽痛,流涕,口乾等”功能主治的基礎上增加“以及慢性阻塞性肺病急性發作期輕度見上述症狀者”;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年3月29日受理的痰熱清膠囊符合藥品註冊的有關要求,同意進行臨牀試驗。

痰熱清膠囊為公司主營產品痰熱清注射液系列產品之一,是公司獨家生產品種,採用全成分提取工藝,吸收好,見效快,療效確切。痰熱清膠囊於2013年年底上市,2019年經醫保談判進入國家醫保目錄,新冠肺炎疫情期間先後被上海、安徽、廣東、福建、河南、貴州等省市列入新冠肺炎診療方案推薦及儲備用藥,形成了強大的核心競爭力,為公司的產品梯隊及長期穩健發展提供有力保障。

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