智通财经APP获悉,诺诚健华(09969)再涨超3%,截至发稿,涨3.4%,报9.72港元,成交额2166.54万港元。
消息面上,近日,诺诚健华发布一季度业绩,实现总营业收入3.81亿元,同比增长129.92%;归属股东净利润1797万元,相较上年同期亏损1.42亿元,实现扭亏转盈。期内,公司核心产品奥布替尼(宜诺凯)销售收入持续增长,共实现销售收入3.11亿元,同比增长89.22%。
浦银国际指出,25Q1奥布替尼销售持续强劲,同比增长至3.11 亿元(+89.2% YoY,+1.2% QoQ),好于预期。考虑到一季度季节性(通常为全年销售最低的季度),正向环比增速显示出积极的商业化进展。
管理层表示,奥布替尼强劲增长主要受益于独家适应症MZL持续放量推动、r/r CLL/SLL市场份额提升以及DOT延长。基于一季度好于预期的销售表现,管理层将全年奥布替尼收入增速从原先的30%YoY上调至35%YoY,公司预计MZL对整体奥布替尼收入贡献占比由2024年30%提升至2025年的50%。
适应症拓展方面,奥布替尼已于4月获批1L CLL/SLL,目前公司正在积极准备该适应症的国谈。临床进展方面,国际PPMS试验(N=700+)预计将在二季度末录入首例病人,SPMS试验(N=900+)预计将在三季度末四季度初录入首例病人,两项国际临床预计需要花3-4年时间完成;中国ITP适应症有望于1H26递交上市申请(预计今年完成病人入组及随访),中国2b期SLE数据有望在4Q25读出,与BCL2联用治疗1L CLL/SLL中国3期已于3月启动入组(预计今年底完成患者入组)。
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