信達生物(01801.HK)：達攸同®獲國家藥品監督管理局批准新適應症
格隆匯 12 月 28日丨信達生物(01801.HK)發佈公吿，公司自主開發的重組抗血管內皮生長因子(“VEGF”)人源化單克隆抗體藥物達攸同®(貝伐珠單抗生物類似藥，英文商標：BYVASDA®)正式獲得國家藥品監督管理局(“NMPA”)批准，在中國用於治療成人複發性膠質母細胞瘤(“GBM”，最常見的原發性腦部惡性腫瘤)，這是達攸同®獲批的第3個適應症。2020年6月17日達攸同®首次獲得NMPA上市批准，用於治療晚期非小細胞肺癌和轉移性結直腸癌。
膠質母細胞瘤是最常見的惡性原發腦腫瘤，佔所有膠質瘤的近57%，佔所有中樞神經系統原發性惡性腫瘤的48%，發生率約為3.2/100,000人口。因為侵襲性強，幾乎所有膠質母細胞瘤在初始治療後都會復發。根據2018年世界衞生組織全球腫瘤調研機構Cancer Today的報吿，2018年中國新增腫瘤病例為428.5萬例、死亡病例為286.5萬例。其中，膠質母細胞瘤是成人中最常見且惡性程度最高的原發性顱內腫瘤，具有高發病率、高複發率、高死亡率和低治癒率的特點。目前膠質母細胞瘤的主要治療方案包括手術切除、放射治療和化療，中位生存時間僅為12-15個月，在過去十年中無明顯變化。因此，膠質母細胞瘤患者迫切需要更多的治療選擇。
達攸同®是公司自主研發的重組抗VEGF人源化單克隆抗體注射液，是貝伐珠單抗的生物類似藥。原研藥貝伐珠單抗注射液自上市以來，全球已批准其用於治療包括非小細胞肺癌、轉移性結直腸癌、膠質母細胞瘤、腎細胞癌、宮頸癌、卵巢癌、輸卵管癌、腹膜癌等多個實體瘤。在國內獲批的適應症為晚期非小細胞肺癌、轉移性結直腸癌和成人複發性膠質母細胞瘤，其顯着的療效和良好的安全性已得到普遍認可。公司相信，達攸同®治療成人複發性膠質母細胞瘤的新適應症成功獲批，將為國內複發性膠質母細胞瘤患者提供一個高質量和高可及性的治療選擇。
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.
