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信达生物-B(1801.HK):信迪利单抗快速放量,研发管线稳步推进
格隆汇 08-29 14:43

机构:国金证券

事件

28日,公司发布半年报,收入约3.46亿元,毛利率88.1%,研发投入约6.7亿元,利润亏损约6.68亿元。整体业绩符合预期,达伯舒快速放量。

点评

信迪利单抗(PD-1)销售快速放量,其潜在临床已超20项。公司核心重磅品种信迪利单抗(PD-1)去年12月份获批上市,于今年3月9日正式开始销售,上半年销售额约3.32亿元人民币,目前已获批适应症为经典性霍奇金淋巴瘤。信迪利单抗在研临床项目已超20项,包括处于三期临床的肺癌、食管癌、肝癌、胃癌等适应症,以及处于早期阶段的NK/T淋巴瘤、黑色素瘤、神经内分泌瘤等适应症。

IBI301、IBI305及IBI303类似物进展顺利,均有望今明年陆续上市。公司临床进展仅次于达伯舒的是三个生物类似物,分别是CD20、VEGF、TNF-α,分别于19年6月、19年1月、18年12月申报NDA,并分别于19年8月、19年4月、19年3月被纳入优先审评,有望今明两年陆续上市。公司产品线梯队分明,核心品种PD1之后仍有三个重磅品种紧随其后,预计明年开始贡献业绩.

在研管线丰富,对外合作积极,储备双抗及 CART等未来品种。公司拥有丰富在研管线,除以上处于临床后期重磅靶点,还有早期的创新大分子CTLA-4、RANKL、OX40、PCSK9、CD47等创新靶点,同时公司还储备了围绕PD-1/PD-L1开展的双特异性抗体品种,目前处于临床早期阶段,以及对外合作的CART和小分子项目(来自Incyte的FGFR、PI3K和JAK1)。公司与和记黄埔合作,开展PD-1+VEGF(信迪利单抗+呋喹替尼)的联合用药方案。公司在研管线丰富,梯队完整,有较多联合用药(Combo)选择,又有未来双抗、小分析、CART项目储备,未来可期。

盈利预测与估值:

根据公司在研管线核心品种的拆分与估值,及已上市品种的拆分和估值,我们预计公司在仅考虑单药治疗的情况下,合理估值应为248亿人民币。未来考虑联合用药方案及潜在早期临床品种,估值预计可达338亿人民币。预计2019-2021三年收入额约7.2/16.0/34.0亿元人民币。

风险提示:

国内外早期在研进展存在风险;核心品种上市后销售竞争存在风险;管理层变动存在不确定性,初创型创新药公司研发和销售可能存在人员变动。

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