新華製藥(00719.HK)解熱鎮痛類非處方藥品布洛芬片通過仿製藥一致性評價
格隆匯5月18日丨山東新華製藥股份(00719.HK)發佈公告,近日,公司收到國家藥品監督管理局核准簽發的布洛芬片(0.1g和0.2g)《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。公司成為國內布洛芬片0.2g第一家、0.1g第二家通過仿製藥一致性評價的企業。
2019年4月新華製藥向國家藥品監督管理局遞交布洛芬片(0.1g和0.2g)仿製藥一致性評價註冊申報資料並獲受理,同年10月31日CDE發出補充研究通知,2020年1月公司完成補充資料的遞交,2020年5月通過仿製藥質量和療效一致性評價審評並獲得《藥品補充申請批件》。
根據披露,布洛芬片為解熱鎮痛類非處方藥品,是醫保甲類藥品,用於緩解輕至中度疼痛如頭痛、關節痛、偏頭痛、牙痛、肌肉痛、神經痛、痛經,也用於普通感冒或流行性感冒引起的發熱。布洛芬是世界衞生組織、美國FDA共同推薦的兒童退燒藥,是公認的兒童抗炎藥。
據Insight數據庫統計,目前於中國境內上市的布洛芬片企業305家,申請仿製藥一致性評價的企業6家。新華製藥生產的0.2g布洛芬片為國內首家通過一致性評價產品。截至該公告日,公司針對布洛芬片的一致性評價已投入研發費用約為人民幣961.64萬元。
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.