智通财经APP获悉，维立志博-B(09887)早盘重挫后逐步转涨，尾盘涨幅扩大逾5%。截至发稿，涨5%，报58.85港元，成交额4573.08万港元。
消息面上，维立志博宣布，核心产品维利信(LBL-024)获欧盟委员会授予的孤儿药资格认定，用于治疗肺外神经内分泌癌(EP-NEC)。这是维利信全球开发进程中又一个重要里程碑，目前，维利信已在非小细胞肺癌(NSCLC)、小细胞肺癌(SCLC)和EP-NEC三个适应症的二期或注册性临床试验中展示出全球首创(FIC)或同类最优(BIC)潜力
根据公告，孤儿药认定为维利信提供多项激励措施，包括10年的市场独占权和监管费用减免等。维利信是一种同时靶向PD-L1与4-1BB的抗体，已在中国的两项临床试验中显示出良好的疗效信号。公司于2024年4月获得国家药品监督管理局批准开展单臂注册临床试验，并在2024年10月获得治疗后线晚期肺外神经内分泌癌的突破性疗法认定。
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