眾生藥業(002317.SZ)：頭孢拉定膠囊獲藥品補充申請批件
格隆匯12月30日丨眾生藥業(002317.SZ)公佈，近日，公司全資子公司廣東華南藥業集團有限公司(“華南藥業”)收到國家藥品監督管理局批准簽發的《藥品補充申請批件》，批件號：2019B04610，藥品名稱為頭孢拉定膠囊。
頭孢拉定膠囊是國家基本藥物，國家醫保目錄甲類品種。頭孢拉定膠囊適用於敏感菌所致的急性咽炎、扁桃體炎、中耳炎、支氣管炎和肺炎等呼吸道感染、泌尿生殖道感染及皮膚軟組織感染等。頭孢拉定作為第一代頭孢菌素類抗生素，因其最低抑菌濃度(MIC)及(或)藥物血清濃維持在MIC以上時間較頭孢氨苄、頭孢克洛及頭孢磺啶均佳，且蛋白結合率較低，對β-內酰胺酶較穩定，腎毒性較低，對多數革蘭氏陽性菌和部分革蘭氏陰性菌都有效，由於其抗菌譜較廣，不良反應較輕，價格適中和使用方便，近20年來，在我國臨牀應用甚為廣泛，已成為臨牀抗感染的一線用藥。查閲米內網中國城市公立醫院化學藥終端競爭格局數據庫顯示，頭孢拉定膠囊2016至2018年銷售額分別為人民幣33892萬元，33839萬元，32240萬元。
公司積極順應國家仿製藥質量和療效一致性評價政策，公司已開展一致性評價品種十多個，除已通過仿製藥一致性評價的鹽酸二甲雙胍片、異煙肼片和頭孢拉定膠囊以外，還有氫溴酸右美沙芬片、利巴韋林片等7個品種已獲得仿製藥一致性評價CDE受理，處於審評審批中，目前研發進度符合預期。此次頭孢拉定膠囊仿製藥質量和療效一致性評價的通過，是公司及華南藥業研發能力、生產及質量管理體系等綜合實力的體現，也是國家藥品監管部門對上述綜合能力和產品質量的認可；同時，也為公司後續品種通過仿製藥質量和療效一致性評價提供了重要的經驗借鑑。本次頭孢拉定膠囊通過仿製藥質量和療效一致性評價，對公司有積極影響，有利於提升產品市場競爭力，擴大產品的市場份額。
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