普利製藥(300630.SZ)：左氧氟沙星片通過荷蘭藥物評價委員會(CBG)技術評審
格隆匯6月5日丨普利製藥(300630.SZ)公佈，近日，公司的全資子公司浙江普利藥業有限公司(“浙江普利”)收到荷蘭藥物評價委員會(CBG)批准左氧氟沙星片的技術評審通知。
藥物名稱：左氧氟沙星片；適應症：左氧氟沙星口服制劑可用於治療成年人(≥18歲)由下列細菌的敏感菌株所引起的下列輕、中、重度感染：醫院獲得性肺炎；醫院獲得性肺炎；急性細菌性鼻竇炎；慢性支氣管炎的急性細菌性發作；複雜性皮膚及皮膚結構感染；非複雜性皮膚及皮膚軟組織感染；慢性細菌性前列腺炎；複雜性尿路感染急性腎盂腎炎；非複雜性尿路感染；吸入性炭疽(暴露後)；劑型：片劑；規格：250mg。
左氧氟沙星片是抗感染類藥物，為減少耐藥菌的產生，保證左氧氟沙星及其他抗菌藥物的有效性，左氧氟沙星只用於治療或預防已證明或高度懷疑由敏感細菌引起的感染。左氧氟沙星口服制劑和注射劑可用於治療成年人(≥18歲)由下列細菌的敏感菌株所引起的下列輕、中、重度感染(參見適應症項下)。如靜脈滴注對患者更為有利時(如患者不能耐受口服給藥等)可使用左氧氟沙星注射液。
浙江普利的左氧氟沙星片於2018年啟動研發，後分別遞交了歐盟和中國(均為仿製藥申請)，屬共線生產產品，左氧氟沙星片中國已進入優先審評序列，目前正在審評中。近日，公司收到荷蘭藥物評價委員會通知，結論為可批准，目前進入荷蘭和德國國家階段的產品特性概要，説明書和標籤的審核和批件發放階段。獲得生產批件後該產品即可在荷蘭、德國市場進行上市銷售，將對公司拓展市場帶來積極的影響。
公司高度重視藥品研發，並嚴格控制藥品研發、製造及銷售環節的質量及安全。由於醫藥產品具有高科技、高風險、高附加值的特點，不僅藥品的前期研發以及產品從研製、臨牀試驗報批到投產的週期長、環節多，而且藥品獲得批件後生產和銷售也容易受到一些不確定性因素的影響。公司將及時根據後續進展履行信息披露義務，敬請廣大投資者謹慎決策，注意防範投資風險。
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.
