浙江医药(600216.SH)：注射用替考拉宁通过一致性评价
格隆汇3月17日丨浙江医药(600216.SH)公布，公司近日收到国家药品监督管理局核准签发的注射用替考拉宁0.2g(20万单位)的《药品补充申请批准通知书》，批准该药品通过仿制药质量和疗效一致性评价(“一致性评价”)。
替考拉宁，又名太古霉素，1975年被首次发现。它是特定的游动放线菌经发酵、提取后得到的一种万古霉素族糖肽类抗生素。通过抑制细菌细胞壁合成抑制和杀灭细菌。替考拉宁的作用位点不同于β-内酰胺类抗生素，通过与D-丙氨酰-D-丙氨酸残基特异性结合，阻断细菌细胞壁的肽聚糖合成。替考拉宁对厌氧的及需氧的革兰阳性菌均有抗菌活性。敏感菌有金黄色葡萄球菌、凝固酶阴性葡萄球菌(包括对甲氧西林敏感及耐药菌)、链球菌、肠球菌、单核细胞增多性李司特菌、细球菌、JK组棒状杆菌和革兰阳性厌氧菌(包括艰难梭状芽孢杆菌和消化球菌)。
适应症：注射用替考拉宁可用于治疗各种严重的革兰阳性菌感染，包括不能用青霉素类和头孢菌素类其他抗生素者，可用于不能用青霉素类和头孢菌素类抗生素治疗或用上述抗生素治疗失败的严重葡萄球菌感染，或对其他抗生素耐药的葡萄球菌感染。已证明替考拉宁对下列感染有效：皮肤和软组织感染，泌尿道感染，呼吸道感染，骨和关节感染，败血症，心内膜炎及持续不卧床腹膜透析相关性腹膜炎。在骨科手术具有革兰阳性菌感染的高危因素时，该品也可作预防用。该品也可口服用于艰难梭状芽孢杆菌感染相关的腹泻和结肠炎的替代治疗。在适当情况下，该品可与其他抗菌药物联合给药。
替考拉宁由原研赛诺菲公司于1988年首次在法国和意大利上市，1989年在德国和英国上市，1998年在日本上市，2000年中国上市。目前注射用替考拉宁国内批准生产企业3家，其中华北制药股份有限公司有两个批准规格，分别为0.2g和0.4g，浙江海正药业股份有限公司和我公司均批准1个规格0.2g，国外进口批准均为赛诺菲公司，规格为0.2g。Cortellis数据查询，2019.09.30-2020.09.30，注射用替考拉宁全球市场规模为2.05亿美元。米内数据查询，2019年注射用替考拉宁国内销售额为7.56亿元。公司注射用替考拉宁(加立信)在国内市场占有重要地位。
公司于2019年01月29日向国家药品监督管理局提交一致性评价获得受理。截至目前，公司用于开展注射用替考拉宁一致性评价已累计投入研发费用约500万元。
公司产品注射用替考拉宁通过仿制药质量和疗效一致性评价有利于该药品未来的市场销售和市场竞争。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
