港股异动 | 乐普生物-B(02157)涨超19% 治疗鼻咽癌ADC新药获FDA授予快速通道资格
乐普生物-B(02157)涨超19%，截至发稿，涨16.26%，报3.79港元，成交额839.11万港元。
消息面上，近日，乐普生物自主研发的EGFR靶向ADC产品MRG003用于治疗晚期鼻咽癌（NPC）获得美国食品和药物监督管理局（FDA）授予快速通道资格（FTD）。根据规定，获得FTD资格的候选药物意味着其有机会通过各种形式加快审评进程。据悉，MRG003于此前已获FDA孤儿药资格（ODD）认定，并获CDE突破性治疗药物（BTD）认定，用于治疗NPC。
太平洋证券研报指出，2023年前三季度，上市ADC药物营收超75亿美元，即将追平2022年全年销售额。该行预测全年销售额将突破百亿，成为ADC领域又一重要的里程碑。目前整个ADC行业处在高速增长阶段，随着ADC获批的数量大幅增加，适应症不断扩大，预计在未来几年ADC整个市场依旧会维持高速增长的状态。该行推荐乐普生物等。
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