羅欣藥業(002793.SZ):子公司頭孢丙烯片通過一致性評價
格隆匯12月24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”)於近日收到國家藥監局核准簽發的頭孢丙烯片《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。
頭孢丙烯是第二代頭孢類口服抗菌藥物,具有抗菌譜廣、活性高且對β-內酰胺酶穩定的特點。頭孢丙烯對肺炎鏈球菌、化膿性鏈球菌、金黃色葡萄球菌等常見病菌具有較強的抗菌活性,臨牀主要用於治療敏感菌所致的輕中度呼吸道、皮膚和軟組織等感染。
頭孢丙烯片最早由Bristol-Myers Squibb Company(簡稱“BMS”)公司研發,並於1991年12月23日首次在美國獲准上市,英文商品名為Cefzil,現已停止生產銷售。BMS原研產品未在中國進口註冊,根據國家藥監局網站數據顯示,目前我國有9家藥品生產企業獲得頭孢丙烯片的批准文號。山東羅欣於2015年3月27日獲得頭孢丙烯片(規格為0.5g)的生產批件,批准文號為國藥準字H20153063。山東羅欣該次提交的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年度頭孢丙烯片的全球市場規模為1.0億美元(以出廠價計算);根據IQVIA、IMS及米內網數據,2020年度頭孢丙烯片國內市場規模為14.8億人民幣(以招標價計算)。
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