中國生物製藥(01177.HK)：1類創新藥貝莫蘇拜單抗注射液"Benmelstobart (TQB2450)"聯合鹽酸安羅替尼膠囊一線治療小細胞肺癌適應症獲批上市
格隆匯5月9日丨中國生物製藥(01177.HK)宣佈，集團自主研發的1類創新藥貝莫蘇拜單抗注射液"Benmelstobart (TQB2450)"(商品名：安得衞)已獲得中國國家藥品監督管理局的上市批准，聯合鹽酸安羅替尼膠囊、卡鉑和依託泊甘用於廣泛期小細胞肺癌(ES-SCLC)患者的一線治療。
貝莫蘇拜單抗是集團自主研發的一款人源化PD-L1單克隆抗體，可以阻止PD-L1與T細胞表面的PD-1和B7.1受體結合，使T細胞恢復活性，從而增強免疫應答。早期多項探索性臨牀數據證明，貝莫蘇拜單抗聯合安羅替尼，在多個瘤種(如非小細胞肺癌、軟組織肉瘤、腎細胞癌、子宮內膜癌、卵巢癌、肝細胞癌、膽管癌等)起到協同增效作用。
此次一線治療小細胞肺癌適應症的獲批，是基於一項貝莫蘇拜單抗聯合安羅替尼、卡鉑和依託泊甘一線治療廣泛期小細胞肺癌的隨機、雙盲、安慰劑對照、多中心、III期臨牀試驗(ETER701)。
ETER701研究結果於2023年世界肺癌大會(WCLC)上公佈：截止2022年5月14日，貝莫蘇拜單抗聯合安羅替尼及化療組、單純化療組的中位無進展生存期(mPFS)分別為6.9個月(95% CI：6.18-8.25)和4.2個月(95% CI：4.17-4.24)，腫瘤復發風險降低68%，差異有顯著統計學意義。貝莫蘇拜單抗聯合安羅替尼及化療組、單純化療組的中位總生存期(mOS)分別為19.3個月(95% CI: 14.23-NE)和11.9個月(95% CI：10.74-13.37)，死亡風險降低39%，差異有顯著統計學意義。安全性方面，未出現非預期的嚴重不良事件，貝莫蘇拜單抗聯合安羅替尼及化療用於ES-SCLC患者的一線治療，整體安全性可控。
肺癌是中國和全球範圍內發病率和病死率較高的惡性腫瘤，其中小細胞肺癌(SCLC)佔肺癌的13%-17%[6]。與非小細胞肺癌不同，SCLC的侵襲性更高，預後較差，5年生存率不足5%[7]，亟需更為有效的治療方案。
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