信達生物(01801.HK)：公司與馴鹿生物共同開發的伊基侖賽注射液新藥上市申請獲國藥監局受理
格隆匯6月2日丨信達生物(01801.HK)宣佈，國家藥品監督管理局("NMPA")已經正式受理由公司與馴鹿生物合作開發的伊基侖賽注射液(信達生物研發代號：IBI326；馴鹿生物研發代號：CT103A)治療復發╱難治性多發性骨髓瘤("R/RMM")的上市許可申請("NDA")。
此次NDA是基於伊基侖賽注射液一項單臂、開放性標籤、多中心1/2期註冊性臨牀(NCT05066646)的研究結果：伊基侖賽注射液在人體內顯示出優異的安全性和有效性，全人源的BCMA抗體序列使產品擁有極低的免疫原性，並擁有長效持久的體內CAR-T擴增和存續，有望成為患者的突破性治療手段。信達生物與馴鹿生物在2021年第63屆美國血液學會("ASH")年會上以口頭報吿形式(摘要編號：547)展示了該項臨牀研究結果，並將在2022年6月12日至19日舉行的2022年歐洲血液學年會("EHA")網絡大會期間以口頭報吿形式(摘要編號：S187)更新1/2期臨牀研究數據。
多發性骨髓瘤("MM")是最常見的血液癌症之一，是一種克隆性漿細胞異常增殖的惡性疾病。對於初治的多發性骨髓瘤患者，常用的一線治療藥物包括蛋白酶體抑制劑、免疫調節類藥物及烷化劑類藥物。對於大多數的患者，常用的一線治療可以使患者的病情穩定3至5年，但也有少部份患者在初治時表現為原發耐藥，病情不能得到有效控制。對於治療有效的大多數初治患者，在經過疾病穩定期後也會不可避免的進入復發、難治階段。因此，復發╱難治多發性骨髓瘤患者仍存在未滿足的需求。根據弗若斯沙利文報吿：中國MM的新發病人數由2016年18,900人增至2020年21,100人，預計2025年將增長至24,500人。中國MM的患病率從2016年69,800人增至2020年113,800人，預計2025年增長至182,200。公司將積極配合國內監管機構，希望推動該適應症早日獲批，為中國多發性骨髓瘤患者帶來突破性的治療選擇。
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