博安生物BA1302获美FDA孤儿药资格认定
3月27日，博安生物（06955）发布公告，公司自主研发的靶向CD228创新抗体偶联药物BA1302已获得美国食品药品监督管理局授予的鳞状非小细胞肺癌和胰腺癌两个适应症的孤儿药资格认定。BA1302是中国首个进入临床阶段、全球唯一处于临床阶段的靶向CD228创新抗体偶联药物，旨在用于多种实体瘤的治疗。
公告中提到，肺癌和胰腺癌的发病率及死亡率均较高，肺癌2022年全球新发248万例、死亡181.7万例，而胰腺癌新发51万例、死亡46.7万例，均显示出对有效治疗方案的迫切需求。
BA1302的抗体筛选采用公司自有知识产权的全人抗体转基因小鼠平台，具有较低的脱靶毒性和优异的抗肿瘤活性。公司目前还在开展BA1301（靶向Claudin18.2）等多款ADC产品的临床试验，展现出广阔的临床应用前景。
（文章来源：财中社）
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