金城醫藥(300233.SZ)子公司獲得注射用頭孢曲松鈉一致性評價受理通知書
格隆匯11月12日丨金城醫藥(300233.SZ)公佈，公司於2019年11月11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”)下發的注射用頭孢曲松鈉一致性評價的受理通知書(CYHB1950784國、CYHB1950785國、CYHB1950786國)。
頭孢曲松鈉為長效、廣譜的第三代半合成頭孢菌素類抗生素，通過抑制細胞壁的合成產生抗菌作用，對絕大多數革蘭陰性菌和陽性菌均具有高效抗菌活性，與其它第三代頭孢菌素相比具有抗菌譜廣、抗菌作用強、對β-內酰胺酶穩定、血藥半衰期長(7～9h)、組織穿透能力強、毒副作用小、療效好等優點。適用於敏感致病菌所致的下呼吸道感染，尤其是肺炎(社區和醫院獲得性肺炎)；耳鼻喉感染；皮膚和軟組織，及傷口感染；成人和包括新生兒(從15日齡開始)在內的兒童的播散性萊姆病【早期(II期)和晚期(III期)】；免疫機制低下患者之感染；腎臟及泌尿系統感染(複雜性和單純性)；生殖系統感染，包括單純性淋病(子宮頸/尿道和直腸)；細菌性敗血症，如膿毒血癥；骨和關節感染；腹腔內感染(腹膜炎、膽道及胃腸道感染)；腦膜炎及手術預防感染。
頭孢曲松最早由瑞士Roche公司研發，1982年首次以商品名為Rocephin®(羅氏芬®)在瑞士上市，1984年獲得美國FDA批准，1996年原研專利到期。據日本IF文件顯示，截止至2016年05月，頭孢曲松已在全球約110個國家批准上市。
頭孢曲松鈉(Ceftriaxone Sodium)在1996年專利期滿後我國有多家醫藥公司仿製成功，是目前國家批准的20多種臨牀應用的頭孢菌素類抗生素製劑品種之一，為國家基本藥物。注射用頭孢曲松鈉已在國內、國外上市且臨牀應用36年。
受理通知書的主要內容為：產品：注射用頭孢曲松鈉；受理號：CYHB1950784國(0.25g)；CYHB1950785國(0.5g)；CYHB1950786國(1.0g)；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；結論：經審查，決定予以受理。
注射用頭孢曲松鈉(0.25g、0.5g、1.0g)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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