再鼎医药早盘涨超5% ZL-1310获美国FDA孤儿药资格认定

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Jan 24, 2025
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  再鼎医药(09688)早盘上涨5.50%,现报21.10港元,成交额1175.27万港元。

  消息面上,1月23日,再鼎医药宣布,美国食品药品监督管理局(FDA)已授予ZL-1310孤儿药资格认定(ODD),ZL-1310是一款高活性的具有同类首创潜力的DLL3 ADC,用于治疗小细胞肺癌(SCLC)。ZL-1310将有资格获得某些开发激励措施,包括免除处方药用户付费法案(PDUFA)的注册申请费,获得相应临床研究的税收抵免,以及在产品获批后有望被授予在美国市场的七年独占期。

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