智通财经APP获悉，康宁杰瑞制药-B(09966)再涨近6%，月内累涨逾65%。截至发稿，涨5.86%，报10.12港元，成交额5129.66万港元。
消息面上，康宁杰瑞制药发布公告，JSKN003已获美国食品药品监督管理局(FDA)授予孤儿药资格认定(ODD)，用于治疗胃癌及胃食管结合部癌(GC/GEJ)。JSKN003是康宁杰瑞利用特有的糖基定点偶联平台自主研发的HER2双抗ADC。
据悉，ODD是FDA鼓励开发用于治疗在美国患病人数低于20万的疾病的创新药措施。JSKN003获得该认定后将有利于后续在美国的研究及开发、注册与商业化等方面获得相关政策支持，包括研发费用资助、临床研究费用税收减免、处方药用户费用豁免、加速上市审评审批等，以及药物获批后有望获得美国市场的7年独占权。
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