生物制药公司驯鹿生物（IASO Bio）宣布其自主研发的全人源抗CD19单克隆抗体IASO-782注射液新药临床试验申请（IND）获国家药品监督管理局（NMPA）默示许可（受理号：CXSL2300272），适应症为自身免疫性血液系统疾病-自身免疫性血小板减少症（ITP）和温抗体型自身免疫性溶血性贫血(wAIHA)，距离该产品美国IND获FDA批准仅隔一周时间。
自身免疫性疾病领域是仅次于肿瘤领域的第二大药物市场，驯鹿生物以开发血液肿瘤药物为基石，深耕自身免疫性疾病领域。驯鹿生物首款用于治疗自免疾病——AQP4-IgG阳性的视神经脊髓炎谱系疾病（Neuromyelitis Optica Spectrum Disorder，NMOSD）的CAR-T产品（伊基奥仑赛注射液，研发代号CT103A）IND于2022年8月获NMPA批准，标志着公司CAR-T疗法从恶性肿瘤领域向自免领域拓展。而此次驯鹿生物另一款产品IASO-782注射液抗体疗法在中国IND的获批，加速了公司创新疗法在自免疾病领域的探索，将为患者带来更多的治疗选择。
此外，驯鹿生物于2022年10月授予 Cabaletta经临床验证的全人源CD19序列在自身免疫性疾病领域开发修饰T细胞产品中的全球独家开发、生产及商业化权利。通过该项合作，驯鹿生物将有资格获得最多两款产品，累计高达1.62亿美元的首付款以及潜在开发和商业化里程碑付款和销售分成。同时，驯鹿生物拥有在大中华区开发Cabaletta使用该许可序列的产品并将其商品化的优先权。目前Cabaletta 使用该许可序列的自免CAR-T产品CABA-201用于治疗活动性狼疮肾炎（LN）或无肾脏受累的活动性系统性红斑狼疮（SLE）和特发性炎症肌病(IIM)两项适应症IND已相继获得FDA批准，计划启动1/2期临床试验。
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