百济神州(06160.HK)研发能力顶尖、最具国际化的创新药标杆
作者：田加强刘泽序
百济神州(06160.HK)是我国研发能力顶尖、最具国际化的创新药企业。Zanubrutinib有望成为全球Best-in-Class的BTK抑制剂，Tislelizumab国内大适应症进展领先，临床效果不输进口产品，Pamiparib有望开辟胃癌一线维持治疗新市场。
▌公司是我国研发能力顶尖、最具国际化的创新药企业。
公司核心管理人员均具有海外留学和工作经验。2018年公司研发费用达到6.79亿美金，同比+152%，在我国医药企业中排名高居第一。公司3个产品的全球多中心内临床均已经进入到后期阶段，其中Zanubrutinib及Tislelizumab有望今年在国内上市。公司近期从港交所生物科技公司变为普通公司上市，具备了被纳入恒生指数的资格。
▌Zanubrutinib有望成为全球BestinClass的BTK抑制剂。
2018年全球BTK抑制剂销售额已经超过40亿美金，且仍在快速增长。Zanubrutinib在体内的BTK抑制效果比IMBRUVICA更加彻底且持久，其中WM、CLL/SLL等适应症有望较Ibrutinib疗效更加优异，且安全性更好，zanubrutinibvs.ibrutinibinWM等重磅临床结果有望于今年下半年开始陆续披露。Zanubrutinib有望成为全球BestinClass的BTK抑制剂，我们预计其国内外合计销售峰值有望达到137亿元。
▌Tislelizumab国内大适应症进展领先，有望下半年获批上市。
PD-1单抗2018年全球销售额达150亿美金，获批适应症仍在不断增加。Tislelizumab国内大适应症(肺癌、肝癌、食管癌、胃癌)进展较快，cHL适应症有望下半年获批上市；公司在收回Tislelizumab全球权益后海外临床进展预计不会受到大幅影响，其有望成为首个海外上市的国产PD-1单抗。同时，Tislelizumab临床效果优异，cHL适应症CR达到63%，联合化疗治疗肺癌ORR平均达到70%以上，有望超越进口产品。预计Tislelizumab国内外合计销售峰值有望达到175亿元。
▌Pamiparib有望开辟胃癌一线维持治疗新市场。
PARP抑制剂2018年全球销售额超过9亿美元，且销售额仍在逐季提升，胰腺癌临床表现闪耀2019年ASCO。Pamiparib具有良好的大脑渗透性，其中铂敏感的胃癌患者一线维持治疗全球III期临床设计具有差异化优势，有望在竞争激烈的卵巢癌市场外开辟出新的市场。预计Pamiparib国内外的销售峰值有望达到38亿元。
▌风险因素。
临床试验进展不达预期或失败风险；药品降价风险。
▌盈利预测及估值。
预计公司2019-21年净利润分别为-8.92亿/-7.32亿/-5.50亿美元，2023年将首次扭亏为盈。综合DCF和PS估值方法，我们认为公司合理估值约为800亿港元，对应目标价102.74港元，首次覆盖，给予“买入”评级。
*声明：文章为作者独立观点，不代表格隆汇立场。
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