羅欣藥業(002793.SZ):注射用頭孢美唑鈉通過一致性評價
格隆匯9月17日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(簡稱“山東羅欣”)於近日收到國家藥品監督管理局核准簽發的注射用頭孢美唑鈉《藥品補充申請批准通知書》。經審查,該藥品通過仿製藥質量和療效一致性評價。
頭孢美唑鈉對β-內酰胺酶高度穩定,對產β-內酰胺酶以及不產β-內酰胺酶的敏感菌具有相同強的抗菌活性。對金黃色葡萄球菌、大腸埃希菌、肺炎桿菌、奇異變形桿菌有良好的抗菌作用,而且對耐頭孢菌素類及耐青黴素類抗生素的通變形桿菌、摩氏摩根菌、普羅維登斯菌屬也有很強的抗菌活性。另外,對消化鏈球菌和擬桿菌屬、普雷沃菌屬(雙路普雷沃菌除外)等厭氧菌也顯示出很強的抗菌作用。其作用機理是強力抑制增殖期細菌的細胞壁合成,而發揮殺菌性作用。
注射用頭孢美唑鈉原研是日本的第一三共株式會社,1979年8月在日本獲得批准上市,為靜脈注射給藥的第二代頭孢菌素。山東羅欣於2010年首次獲得注射用頭孢美唑鈉(規格:0.5g,1.0g)生產批件,批准文號分別為國藥準字H20103441,國藥準字H20103442。山東羅欣該次提交的2個規格質量與療效一致性評價申請於日前獲得《藥品補充申請批准通知書》。
根據IQVIA數據,2020年度注射用頭孢美唑鈉的全球市場規模為1.9億美元(以出廠價計算),國內市場規模為14.59億人民幣(以招標價計算)。
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