新華製藥(000756.SZ):頭孢氨苄膠囊通過仿製藥一致性評價
格隆匯2月13日丨新華製藥(000756.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的頭孢氨苄膠囊(0.25g和0.125g)的《藥品補充申請批件》,該產品通過仿製藥質量和療效一致性評價。
頭孢氨苄屬於第一代口服頭孢菌素類抗生素藥物,最早由美國EliLilly公司合成,臨牀主要用於治療敏感菌所致的輕度感染。本公司選用國家公佈的第7批參比製劑目錄中美國PRAGMA公司生產的0.25g頭孢氨苄膠囊為參比製劑。頭孢氨苄具有口服吸收好、毒性小、抗菌譜廣的優點,《抗菌藥物臨牀應用指導原則》2015年版推薦第一代頭孢菌素為急性細菌性呼吸道感染、尿路感染、皮膚軟組織感染的宜選或可選用藥,被《2018NICE/PHE指南:導尿管相關尿路感染的抗菌藥物處方》推薦為一線用藥。截至本公告日,公司針對該產品的一致性評價已投入研發費用約為人民幣900萬元。
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