科倫藥業(002422.SZ):注射用頭孢他啶通過一致性評價
格隆匯4月29日丨科倫藥業(002422.SZ)宣佈,公司子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“注射用頭孢他啶”的《藥品補充申請批准通知書》。
近日公司的注射用頭孢他啶通過一致性評價並獲得藥品補充申請批准通知書,主要用於治療敏感微生物引起的單一或多重感染,包括全身性重度感染,下呼吸道感染,耳鼻喉感染,尿路感染等。
頭孢他啶為強效、廣譜的第三代頭孢菌素類抗生素,較第一、二代頭孢菌素對革蘭氏陰性菌活性與β-內酰胺酶穩定性增強;與其他第三代頭孢菌素相比,對銅綠假單胞菌作用最強,常作為敏感菌的首選用藥之一,目前已在臨牀廣泛應用於神經內科、呼吸科、外科等科室,已被《抗菌藥物臨牀應用指導原則(2015)》、《中國腹腔感染診治指南(2019)》、《外科常見腹腔感染多學科診治專家共識(2021)》、《神經外科中樞神經系統感染診治中國專家共識(2021)》等國內權威指南推薦。注射用頭孢他啶為2020版國家醫保乙類品種,及2018年版國家基藥目錄品種,2019年中國銷售額60.1億元。
注射用頭孢他啶為第五批國家組織藥品集中採購品種,該次公司注射用頭孢他啶通過一致性評價,成功獲得了參與集採申報的資格,有利於進一步提升該品種的市場競爭力。
目前公司已有系列腸外營養、感染、麻醉鎮痛、體液平衡類產品獲批或通過一致性評價,且劑型和包裝形式多樣,已在相關疾病領域形成優勢產品集羣,可為臨牀提供針對圍手術期用藥的系統解決方案。
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