浙江醫藥(600216.SH)：注射用替考拉寧通過一致性評價
格隆匯3月17日丨浙江醫藥(600216.SH)公佈，公司近日收到國家藥品監督管理局核准簽發的注射用替考拉寧0.2g(20萬單位)的《藥品補充申請批准通知書》，批准該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。
替考拉寧，又名太古黴素，1975年被首次發現。它是特定的遊動放線菌經發酵、提取後得到的一種萬古黴素族糖肽類抗生素。通過抑制細菌細胞壁合成抑制和殺滅細菌。替考拉寧的作用位點不同於β-內酰胺類抗生素，通過與D-丙氨酰-D-丙氨酸殘基特異性結合，阻斷細菌細胞壁的肽聚糖合成。替考拉寧對厭氧的及需氧的革蘭陽性菌均有抗菌活性。敏感菌有金黃色葡萄球菌、凝固酶陰性葡萄球菌(包括對甲氧西林敏感及耐藥菌)、鏈球菌、腸球菌、單核細胞增多性李司特菌、細球菌、JK組棒狀桿菌和革蘭陽性厭氧菌(包括艱難梭狀芽孢桿菌和消化球菌)。
適應症：注射用替考拉寧可用於治療各種嚴重的革蘭陽性菌感染，包括不能用青黴素類和頭孢菌素類其他抗生素者，可用於不能用青黴素類和頭孢菌素類抗生素治療或用上述抗生素治療失敗的嚴重葡萄球菌感染，或對其他抗生素耐藥的葡萄球菌感染。已證明替考拉寧對下列感染有效：皮膚和軟組織感染，泌尿道感染，呼吸道感染，骨和關節感染，敗血症，心內膜炎及持續不卧牀腹膜透析相關性腹膜炎。在骨科手術具有革蘭陽性菌感染的高危因素時，該品也可作預防用。該品也可口服用於艱難梭狀芽孢桿菌感染相關的腹瀉和結腸炎的替代治療。在適當情況下，該品可與其他抗菌藥物聯合給藥。
替考拉寧由原研賽諾菲公司於1988年首次在法國和意大利上市，1989年在德國和英國上市，1998年在日本上市，2000年中國上市。目前注射用替考拉寧國內批准生產企業3家，其中華北製藥股份有限公司有兩個批准規格，分別為0.2g和0.4g，浙江海正藥業股份有限公司和我公司均批准1個規格0.2g，國外進口批准均為賽諾菲公司，規格為0.2g。Cortellis數據查詢，2019.09.30-2020.09.30，注射用替考拉寧全球市場規模為2.05億美元。米內數據查詢，2019年注射用替考拉寧國內銷售額為7.56億元。公司注射用替考拉寧(加立信)在國內市場佔有重要地位。
公司於2019年01月29日向國家藥品監督管理局提交一致性評價獲得受理。截至目前，公司用於開展注射用替考拉寧一致性評價已累計投入研發費用約500萬元。
公司產品注射用替考拉寧通過仿製藥質量和療效一致性評價有利於該藥品未來的市場銷售和市場競爭。
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