永泰生物-B(06978.HK):CAR-T-19注射液第一期臨牀試驗的首例患者入組
格隆匯6月11日丨 永泰生物-B(06978.HK)公吿,集團管線產品之一的CAR-T-19注射液產品已於2021年6月10日在中國完成其第一期臨牀試驗的首例患者入組,標誌着集團開發其CAR-T細胞管線產品的里程碑。
基於CAR-T-19注射液的臨牀試驗進展及在並無不可預見的情況下,預計將於2022年第一季度完成目標患者招募,並將於2022年公佈初步分析及結果。
CAR-T-19注射液為集團CAR-T細胞產品系列中的第一個在研產品。集團擬為B-ALL及B細胞淋巴癌開發CAR-T-19。ALL是急性白血病的亞型之一。其特徵為未成熟血細胞數量快速增加,其中血細胞的DNA突變,並且不能生長成為正常細胞。ALL在兒童中比在成人中更常見。於2015年,在中國約有12,000名新增的B-ALL患者,當中難治復發的病例佔30%。新增的ALL患者數目由2014年約11,600人增至2018年約12,400人。
於2018年,在中國約有10,700名18歲以下兒童新增患上ALL,佔於中國的ALL患者總數86.3%。由於早期篩查的發展,估計於2023年將達到13,400例,於2030年將達到14,700例。
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