信達生物(01801.HK)：貝伐珠單抗生物類似藥達攸同®獲國家藥監局批准上市
格隆匯6月19日丨信達生物(01801.HK)宣佈，公司自主研發的重組人源化抗血管內皮生長因子(“VEGF”)單克隆抗體藥物達攸同®(貝伐珠單抗生物類似藥)獲國家藥品監督管理局(“NMPA”)上市批准，用於在中國治療晚期非小細胞肺癌和轉移性結直腸癌患者。達攸同®是繼達伯舒®(信迪利單抗注射液，於2018年12月正式獲批用於治療至少經過二線治療的復發╱難治性經典型霍奇金淋巴瘤)之後，信達生物第二個獲得NMPA上市批准的單克隆抗體藥物。
近年來，中國癌症負擔在持續增長。在中國各類惡性腫瘤中，肺癌發病率和死亡率均居第一位，結直腸癌發病率和死亡率分別位居第二位和第五位。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、膠質瘤、腎細胞癌、宮頸癌和上皮性卵巢癌、輸卵管癌或原發性腹膜癌在內的多種惡性腫瘤患者。目前在國內獲批的適應症為晚期非小細胞肺癌和轉移性結直腸癌。
其顯著的療效和良好的安全性已在世界範圍內得到普遍認可。當前中國仍存在巨大未被滿足的貝伐珠單抗注射液治療臨牀需求，因為很多普通患者承擔不起貝伐珠單抗注射液的治療費用。達攸同®的上市將為中國患者提供高品質且相對更為可負擔得起的貝伐珠單抗注射液。2020年1月，集團將達攸同®在美國和加拿大的商業化權益授權給Coherus BioSciences公司，集團期待雙方共同推進達攸同®讓更多全球患者受益。
據悉，達攸同®為貝伐珠單抗注射液生物類似藥，又名重組抗VEGF人源化單克隆抗體注射液。VEGF是一種血管生成過程中重要的因子，在多數人類腫瘤內皮細胞中過度病理表達。抗VEGF抗體，可以高親和力地選擇性結合VEGF，通過阻斷VEGF與其血管內皮細胞表面上的受體結合，阻斷PI3K-Akt/PKB和Ras-Raf-MEK-ERK等信號通路的傳導，從而抑制血管內皮細胞的生長、增殖、遷移以及血管新生，降低血管滲透性，阻斷腫瘤組織的血液供應，抑制腫瘤細胞的增殖和轉移，誘導腫瘤細胞凋亡，從而達到抗腫瘤的治療效果。
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、膠質瘤、腎細胞癌、宮頸癌和上皮性卵巢癌、輸卵管癌或原發性腹膜癌在內的多種惡性腫瘤患者。目前在國內獲批的適應症為晚期非小細胞肺癌和轉移性結直腸癌。其顯著的療效和良好的安全性已在世界範圍內得到普遍認可。
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.
