東曜藥業-B(01875.HK):抗體藥物樸欣汀®在中國大陸獲批上市!
格隆匯12月1日丨東曜藥業-B(01875.HK)宣佈,集團自主研發的樸欣汀®(TAB008,貝伐珠單抗注射液,英文商標:Pusintin®)正式獲得國家藥品監督管理局(”NMPA“)的上市批准,可在中國大陸上市,用於晚期、轉移性或者複發性非鱗狀非小細胞肺癌(”nsNSCLC“)和轉移性結直腸癌(”mCRC“)患者的治療。樸欣汀®是集團首個獲批上市的抗體藥物。
樸欣汀®是一種抗血管內皮細胞生長因子單克隆抗體(抗VEGF mAb),為安維汀®的生物類似藥。安維汀®一直是最廣泛使用的抗VEGFmAb藥物,自2004年進入市場以來,其療效及安全性得到了廣泛的實踐證明。安維汀®在其他國家獲批多個適應症,可結合化療等療法來治療各種腫瘤,包括mCRC、晚期nsNSCLC、惡性膠質瘤、腎細胞癌、卵巢癌、宮頸癌、乳腺癌和肝癌。安維汀®在中國已獲批用於治療nsNSCLC、mCRC、膠質母細胞瘤(GBM)、肝細胞癌(HCC)、卵巢癌和宮頸癌。根據NMPA藥品審評中心發佈的《生物類似藥相似性評價和適應症外推技術指導原則》,樸欣汀®將可外推申請安維汀®在中國獲批的全部適應症。
根據世界衞生組織國際癌症研究機構(IARC)資料,肺癌和結直腸癌為中國癌症新發病例數最多的兩大癌症,於2020年,其新發病例數分別為約81.6萬人和55.5萬人。基於其廣泛的適應症和大量的患者需求,貝伐珠單抗注射液在中國存在巨大未被滿足的市場空間。公司相信樸欣汀®將為廣大的中國癌症患者提供高品質且經濟的治療選擇。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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