貝達藥業(300558.SZ)：將在中國區域內啟動Balstilimab和Zalifrelimab相關的臨牀研究
格隆匯 8 月 6日丨貝達藥業(300558.SZ)公佈，公司第三屆董事會第八次會議和2020年第二次臨時股東大會審議通過《關於公司投資引進PD-1和CTLA-4項目的議案》，同意公司與Agenus Inc.(NASDAQ:AGEN，“Agenus”)達成合作，以自有資金支付Agenus1500萬美元的首付款，同時通過貝達投資(香港)有限公司(“貝達投資”)以約2000萬美元現金認購Agenus增發的4,962,779股，貝達藥業取得在中國(包括香港、澳門和台灣，下同)區域內單用或聯用治療除膀胱內給藥外的所有腫瘤學和非腫瘤學適應症的獨家開發並商業化Balstilimab(PD-1抗體)和Zalifrelimab(CTLA-4抗體)的權利。
公司已根據《獨佔許可協議》的約定支付了1500萬美元的首付款，並根據《股權認購協議》通過貝達投資支付了約2000萬美元的股權認購款，股份交割已辦結，交割後佔Agenus2.71%股權。
公司取得在中國區域內獨家開發和商業化Balstilimab和Zalifrelimab單用或聯用(包括二者聯用以及分別與公司產品或與其他公司產品聯用)治療除膀胱內給藥外的所有腫瘤學和非腫瘤學適應症的權利。
目前，Agenus正在對Balstilimab和Zalifrelimab展開Ⅱ期臨牀試驗，計劃在2020年年底向美國FDA遞交Balstilimab單一療法在難治性宮頸癌適應症的上市申請，並之後向美國FDA遞交Balstilimab和Zalifrelimab二者聯用在難治性宮頸癌適應症的上市申請。貝達藥業將在中國區域內啟動Balstilimab和Zalifrelimab相關的臨牀研究。
近年來，公司通過戰略合作和自主研發兩種方式逐步充實了公司的研發管線，探索出一條紮根小分子靶向藥物、拓展大分子藥物研發、同時開展聯合用藥研究的創新道路。此次引進Balstilimab和Zalifrelimab將進一步充實公司研發管線，彌補公司在大分子創新藥領域的短板。
公司將加緊推進Balstilimab和Zalifrelimab的新藥上市工作，短期內對公司經營不會產生影響，考慮到申報上市週期較長，在工作過程中不可預測因素較多，敬請廣大投資者注意防範投資風險，謹慎決策。
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