金城醫藥(300233.SZ)子公司獲注射用頭孢他啶一致性評價受理通知書
格隆匯12月9日丨金城醫藥(300233.SZ)公佈，山東金城醫藥集團股份有限公司於近日收到控股子公司廣東金城金素製藥有限公司(“金城金素”)的通知，金城金素收到國家藥品監督管理局(“國家藥監局”)下發的注射用頭孢他啶一致性評價的受理通知書(CYHB1950852國、CYHB1950853國、CYHB1950854國)。
頭孢他啶屬於半合成的第三代頭孢菌素類抗生素，於1983年由英國葛蘭素(Glaxo)公司首先將其開發上市，並分別於1985年、1986年獲准在美國、日本上市銷售，現已在全球多個國家或地區使用，以BRAND-NAME有Fortum®(復達欣)、TAZIDIME®(泰司汀)和FORTAZ®(復達斯)等。
頭孢他啶具有抗菌譜廣、耐酶等特點，通過抑制細菌細胞壁合成而產生殺菌活性。頭孢他啶在部分β -內酰胺酶(包括革蘭陰性和革蘭陽性菌中的青黴素酶和頭孢菌素酶)存在下，仍具有抗菌活性。頭孢他啶適用於治療敏感微生物引起的單一或多重感染，如全身性重度感染、下呼吸道感染(包括肺炎)、耳鼻喉感染、尿路感染、皮膚和軟組織感染、骨和關節感染、婦科感染、胃腸道、膽道和腹部感染、血液/腹膜透析和持續性非卧牀腹膜透析(CAPD)相關感染、中樞神經系統感染(包括腦膜炎)，以及預防圍手術期尿路感染，也可單獨用於經敏感試驗結果確診的腦膜炎患者等。
頭孢他啶於1992年首次在我國上市，並被列入2018年國家基本藥物目錄與2019年國家基本醫保目錄品種。
產品：注射用頭孢他啶；受理號：CYHB1950852國(1.0g)；CYHB1950853國(0.5g)；CYHB1950854國(2.0g)；申請事項：報國家藥品監督管理局審批的補充申請事項：修改藥品註冊標準；進口藥品、國內生產的注射劑、眼用製劑、氣霧劑、粉霧劑、噴霧劑變更直接接觸藥品的包裝材料或者容器；使用新型直接接觸藥品的包裝材料或者容器；其他(一致性評價)劑型：注射劑申請人：廣東金城金素製藥有限公司結論：經審查，決定予以受理。
注射用頭孢他啶(0.5g、1.0g、2.0g)被國家藥監局藥品審評中心受理，標誌着該產品的一致性評價工作進入了審評審批階段。公司將積極推進其後續相關工作，如順利通過一致性評價將享受國家關於通過一致性評價藥品品種的鼓勵和支持政策，提升其市場競爭力，對公司的經營業績產生積極的影響。
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