綠葉製藥(02186.HK):博優諾獲中國藥監局批准用於治療肝細胞癌
格隆匯8月23日丨綠葉製藥(02186.HK)發佈公吿,集團附屬公司山東博安生物技術股份有限公司的貝伐珠單抗注射液(LY01008,博優諾)已獲中國國家藥品監督管理局(NMPA)批准,用於治療肝細胞癌。這是博優諾獲批的第4個適應症。此前,博優諾已獲NMPA批准,用於治療晚期、轉移性或複發性非小細胞肺癌、轉移性結直腸癌和複發性膠質母細胞瘤。
肝癌是中國常見的惡性腫瘤之一。據世界衞生組織國際癌症研究機構(IARC)2020年全球最新癌症負擔數據顯示:2020年全球新發肝癌91萬例,其中中國新發肝癌41萬例,佔全球45%以上。在中國,肝癌已成為第二大癌症殺手,肝癌死亡人數高達39萬人,接近於發病人數。中國肝癌的5年生存率僅為12.1%,處於高發病,低生存的現狀,嚴重影響中國居民的生命健康。
目前,貝伐珠單抗聯合阿替利珠單抗作為首個獲批的不可切除肝細胞癌一綫免疫聯合方案,已被多項國內外權威指南以最優證據級別、最高推薦等級列為肝癌一綫治療方案。此次博優諾?新適應症的獲批將為肝癌患者提供新的治療選擇,惠及更多病患羣體。
據悉,博優諾是博安生物自主研發的重組抗VEGF人源化單克隆抗體注射液,是安維汀的生物類似藥。安維汀(Avastin)在全球範圍內已獲批用於治療非小細胞肺癌、結直腸癌、膠質母細胞瘤、腎細胞癌、宮頸癌、卵巢癌等多個實體瘤,顯著的療效和良好的安全性已得到普遍認可。根據IQVIA數據,貝伐珠單抗注射液於2020年的全球銷售額為60.9億美元,在中國的銷售額為人民幣36.3億元。
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