You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
海普瑞(002399.SZ):全資孫公司註冊成為美國市場依諾肝素鈉製劑供應商
格隆匯 09-21 20:25

格隆匯 9 月 21日丨海普瑞(002399.SZ)公佈,公司全資孫公司深圳市天道醫藥有限公司(“天道醫藥”)近日收到通知,美國食品藥管理(“FDA)已批准其註冊成為美國一家依諾肝素鈉製劑上市許可持有(該持有人在仿製藥銷售領域擁有廣泛的渠道和豐富的經驗,2019年實現淨銷售收入近億美元)藥品及原料藥供應商

至此,天道醫藥的InhixaNeoparinProlongin三個品牌的依諾肝素鈉製劑產品,已合共在35個國家獲批並在21個國家實現銷售;此外天道醫藥向包括美國在內的其他15個國家的客户供應依諾肝素鈉注射液。此次獲批是天道醫藥諾肝素鈉原料藥的藥物主文件(DMF,Drug Master File)在美首次FDA批准活應用。

美國是全球依諾肝素鈉製劑銷售的主要市場之一,根據弗若斯特沙利文發佈報告,2019年美國依諾肝素鈉製劑市場銷售額為4.55億美元,約佔全球市場銷售額的17%;預計美國市場將以10.7%的年複合增長率於2025年達到8.38億美元。

2020年上半年,公司依諾製劑全球銷售額同比增長37%,達6.4億元人民幣。天道醫藥與美國依諾肝素鈉製劑上市許可持有人戰略合作夥伴,由天道醫藥應藥品,該合作伙伴負責所有銷售與分銷相關費用。本次獲批註冊是公司製劑業開拓美國市場的起點,預將於2020年內實現銷售未來美國的製劑業務長將進一步鞏固公司的全球佈局

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.
uSMART
Wealth Growth Made Easy
Open Account