港股异动 | 科伦博泰生物-B(06990)午后涨超9% 美国FDA近日批准SKB518新药临床试验申请

智通财经
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智通财经APP获悉,科伦博泰生物-B(06990)午后涨超9%,截至发稿,涨8.53%,报328.2港元,成交额2.46亿港元。

消息面上,科伦博泰生物此前发布公告,公司已获得美国FDA批准启动其创新抗体偶联药物(ADC)药物SKB518临床研究的新药临床试验(IND)申请。于2024年6月,公司收到国家药品监督管理局药品审评中心批准SKB518用于晚期实体瘤的IND申请的临床试验通知书。SKB518的1期临床试验正在中国进行中。

平安证券发布研报称,截至2025年4月,科伦博泰旗下30余款在研产品,拥有三款商业化产品,核心品种芦康沙妥珠单抗国内已获批两项适应症,全球合作伙伴MSD围绕TROP2 ADC已开展12项注册3期研究,公司坚持创新研发,在ADC领域首款RDC项目迈入临床,在非ADC方面逐步迎来收获期,公司稳步向“创新研发、全球合作、商业化销售”综合型药企转型,预计2025-2027年公司实现收入18.24/28.75/45.21亿元,首次覆盖给予“推荐”评级。

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