信達生物(01801.HK):達攸同®(貝伐珠單抗注射液)在印度尼西亞獲批
格隆匯6月14日丨信達生物(01801.HK)發佈公吿,達攸同®(貝伐珠單抗注射液,印尼商標:Bevagen®)獲得印度尼西亞食品藥品監督管理局(“BPOM”)批准用於治療轉移性結直腸癌,轉移性三陰性乳腺癌,晚期非小細胞肺癌,卵巢癌及宮頸癌五項適應症。2021年1月18日,公司與印度尼西亞生物科技公司PT Etana Biotechnologies Indonesia(“Etana”)關於達攸同®簽訂合作協議,公司授予Etana達攸同®在印度尼西亞的獨家許可,Etana致力於將達攸同®推向當地市場。此次獲批意味着達攸同®(貝伐珠單抗注射液)有望成為第一個在東南亞商業化和本地化生產的中國抗體藥。
根據GLOBOCAN 2020,印尼每年新發癌症病例中排名前五的癌症分別為,乳腺癌(16.6%),宮頸癌(9.2%),肺癌(8.8%),肝癌(5.4%)以及結直腸癌(4.4%)。此次達攸同®(貝伐珠單抗注射液)在快速發展的印尼市場獲批,標誌着公司正穩健推進其創新產品管線進入全球市場的又一里程碑,造福更多全球患者。公司相信,憑藉Etana在當地的商業化能力和達攸同®(貝伐珠單抗注射液)顯著的臨牀療效、高質量的生產品質以及相對的可及性,該產品將很快在印尼上市,為印尼癌症患者帶去新的希望。
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