綠葉製藥(02186.HK):腫瘤治療產品貝伐珠單抗注射液(LY 01008)中國上市許可申請獲受理
格隆匯4月16日丨綠葉製藥(02186.HK)發佈公告,集團腫瘤線產品貝伐珠單抗注射液( LY 01008,Avastin 的生物類似藥)的上市許可申請已獲國家藥品監督管理局藥品審評中心受理。
該上市許可申請乃基於兩項臨牀研究所得的臨牀數據,即健康志願者中的藥代動力學PK比對研究、轉移性或複發性非鱗狀細胞非小細胞肺癌患者中的療效及安全性比對研究,兩者均將LY 01008與Avastin ( 安維汀)作對比。兩項研究均達到預設等效標準。
LY 01008 為適用於非小細胞肺癌或結腸直腸癌的貝伐珠單抗注射液,而根據公開的財務報告,Avastin ( LY 01008的市場可比產品 )於2019年的全球銷售額為70.7億瑞士法郎,2019年在中國的銷售額為人民幣28.8億元( IQVIA數據)。
肺癌和結腸直腸癌在中國分別為第一大和第三大的腫瘤,2018年全球肺癌新發病例高達209 萬餘例,致死人數高達176萬餘例;其中非小細胞肺癌佔比85%。2018年中國約有77.4萬新增肺癌病例,每年約有69萬人死於肺癌。結直腸癌在中國發病則僅次於肺癌和胃癌, 2018年統計年新發病例42.9萬例,死亡病例28.1萬例。持續增長的患者數預示相應的生物類似藥將迎來巨大的市場需求。
董事會相信,LY 01008的研發進展將推動該產品的上市進度並進一步豐富集團的腫瘤產品線。而集團於腫瘤領域強大的行銷能力和廣闊的市場覆蓋將為LY 01008 未來的上市提供強勁的支持。
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.