中國抗體-B(03681.HK)2019年於管線開發等項目取得重大進展
格隆匯3月23日丨中國抗體-B(03681.HK)公告,截至2019年12月31日止年度,報告期的全面虧損總額約為人民幣2.73億元,較截至2018年12月31日止年度增加約人民幣1.93億元,主要由於研究與發展開支及行政開支增加(符合集團的SM03及SN1011臨牀試驗發展),以及合作開發產品的里程碑付款、知識產權轉讓費用及上市開支所致。
截至2019年12月31日止年度,融資活動所得現金淨額約為人民幣14.2億元。報告期內投資活動所用現金淨額約為人民幣4229萬元,主要由於興建蘇州生產基地所致,此舉將大幅提升集團的產能。
董事會不建議就報告期派發末期股息。
於報告期,集團的臨牀試驗項目、管線開發及商業化準備均取得重大進展,其中包括:SM03(潛在的同類靶點首創抗CD22單克隆抗體藥物)類風濕性關節炎的III期臨牀試驗已於2019年開始招募患者。於2019年12月31日,已招募合共288名患者,並已接受指定藥物治療。
就SN1011在澳洲進行的免疫性疾病I期臨牀試驗而言,於2020年1月15日,單次遞增劑量臨牀試驗已完成,當中有40名受試者參與臨牀試驗,概無嚴重不良事件。臨牀試驗已進入多次遞增劑量,現時的安全性符合預期。
於2019年1月17日,公司就合作開發SM17與LifeArc訂立協議,SM17為人源單克隆抗體以對抗在2型先天淋巴細胞內發現的受體IL17BR。
就蘇州商業化規模生產基地的興建而言,該生產基地佔地約7,000平方米,建成後總產能為6000升(公司現時總產能為1200升),於2019年12月31日,已完成行政區、測試實驗室及研發實驗室。
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