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綠葉製藥(02186.HK):博優諾獲批准用於治療複發性膠質母細胞瘤
格隆匯 07-28 21:07

格隆匯7月28日丨綠葉製藥(02186.HK)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,用於治療複發性膠質母細胞瘤(GBM)。這是博優諾獲批的第3個適應症。此前,博優諾於2021年4月獲得NMPA上市批准,用於治療晚期、轉移性或複發性非小細胞肺癌和轉移性結直腸癌。

GBM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%,具有高發病率、高複發率、高死亡率和低治癒率的特點,被認為是神經外科領域治療難度最高的腫瘤之一。目前GBM的主要治療方案包括手術切除、放射治療和化療,但總體預後仍然很差,長期生存率很低,中位生存期小於2年。因此,GBM患者迫切需要更多的治療選擇。

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《生物類似藥相似性評價和適應症外推技術指導原則》,博優諾可以逐步申請獲批安維汀在中國獲批的全部適應症。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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