珍寶島(603567.SH):獲BE公司指定為注射用達託黴素(500mg)產品中國區獨家經銷商商
格隆匯3月1日丨珍寶島(603567.SH)公佈,近日,公司與BIOLOGICAL E. LTD.(以下簡稱"BE")簽署了《供應協議》, BE公司指定珍寶島作為其生產的注射用達託黴素(500mg)產品,在中國區域的營銷、銷售和分銷的獨家經銷商。根據協議規定,在考慮向中國大陸授予產品排他性許可時,珍寶島將按照里程碑向BE支付注射用達託黴素(500mg)許可費10萬美元。
BE公司是印度主要的製藥和疫苗生產商,擁有70年悠久歷史,是一家多產品、多核心和多市場運營的公司,主要產品領域包括抗感染、罕見病、呼吸疾病、胃腸道疾病等。BE公司位於印度特蘭加納州海德拉巴的最新的現代化工廠,經美國食品藥品監督管理局(USFDA)和日內瓦世衞組織(WHO)資格預審。在其印度Kolthur廠區增加的最新的注射劑工廠,已獲得美國FDA認證。 達託黴素等注射劑產品已獲得美國食品藥品監督管理局(USFDA)的仿製藥申請(ANDA)批准。
達託黴素原研公司為禮來公司(Eli Lilly & Co ),禮來公司將達託黴素開發權利授權給Cubist Pharmaceutical(以下簡稱"Cubist"),後Cubist公司被美國默沙東公司(Merck & Co )收購。2003年注射用達託黴素在美國批准上市,用於治療金黃色葡萄球菌(包括耐甲氧西林金黃色葡萄球菌 MRSA),化膿性鏈球菌,無乳鏈球菌,擬乳鏈球菌變種亞種和糞腸球菌(僅對萬古黴素敏感的分離株)引起的複雜的皮膚和皮膚軟組織感染(cSSSI);2006年美國食品藥物管理局(FDA)批准注射用達託黴素用於成年和小兒患者(1至17歲)的金黃色葡萄球菌血液感染(菌血症),包括由甲氧西林敏感金黃色葡萄球菌(MSSA)和耐甲氧西林金黃色葡萄球菌(MRSA)起的右側感染性心內膜炎(RIE)感染。在歐盟,該藥用於治療複雜的皮膚和軟組織感染(cSSTI),金黃色葡萄球菌引起的RIE和與RIE或複雜的皮膚和軟組織感染(cSSTI)相關的金黃色葡萄球菌菌血症。中國批准的適應症與美國類似。
達託黴素的全球峯值銷售出現在2015年,2015年全球市場約12.8億美元。根據米內網公立醫療機構終端數據,達託黴素2018年中國市場規模人民幣6,000萬元左右,與2017年同比增長100.54%,主要公司包括江蘇恆瑞、海正、中美華東、Cubist,其中恆瑞佔據50.09%市場份額,海正佔據22.94%的市場份額,中美華東佔據22.69%市場份額,Cubist佔據4.29%市場份額。
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.