医药行业深度研究PD-1头部企业的盛宴
机构：中信建投
摘要
海外PD-1市场格局：Top10大品种，主要卖肺癌适应症。2018年，Keytruda销售额达到71.7亿元，OPDIVO销售额达到67.4 亿元，二者均进入全球Top10单品。由于疗效出众和患者人群众多，肺癌是最大适应症，占据PD-1市场约40%市场份额， 其中，Keytruda凭借其出色的产能力和优秀的肺癌临床设计方案，成功超过OPDIVO成为肺癌领域最大PD-1。第三家获批 的是赛诺菲/再生元的Libtayo，目前仅4个登记临床，2018年销售额0.15亿美元，考虑到头部两家公司适应症和临床进展已 大幅领先，部分跨国公司已战略性放弃，目前头部格局已成型。
临床设计和临床证据决定海外PD-1市场格局。 OPDIVO以免疫联用为特色，但目前仅在黑色素瘤、尿路上皮癌等适应症 上展现出明显优势，Keytruda没有免疫联用，但其联用布局多样化，具备较大潜力。OPDIVO选择以TMB作为主要生物标 志物，但临床试验不成功，需要重新设置阈值。Keytruda选择以PD-L1作为主要生物标志物，在PD-L1>=50%和PD-L1 1%~49%均做出了阳性结果，成功的临床设计和优秀的临床证据使得Keytruda夺得肺癌之王。
海外PD-1未来市场和竞争推演：更多机会在联用。OPDIVO和Keytruda正在分别开展超过800项临床试验，适应症分布基 本与患病人群分布匹配，联用方案均涵盖放疗、化疗、大分子、小分子靶向药，其中OPDIVO免疫联用试验有150多项， 目前疗效不乐观，Keytruda由于默克公司没有其他免疫方案，没有开展免疫联用，但在与小分子联用上表现出色，预计 Keytruda仍将保持优势。
国内PD-1的竞争格局预判：龙头差异化竞争。大适应症，尤其是肺癌，国内龙头公司必争之地，其中恒瑞医药在肺癌、 肝癌领域布局全面而且领先，联用方案丰富。百济神州海外临床领先，肺癌、肝癌国内进度和布局仅次于恒瑞，联用方 案丰富。信达生物肺癌进度基本与百济神州一致，但肝癌和联用落后于恒瑞、百济。君实生物采取“农村包围城市”策 略，在黑色素瘤、鼻咽癌、尿路上皮癌等小适应症进度领先，肺癌、肝癌相对落后，联用方案以外部合作为主。
投资建议：综合考虑产品差异、临床设计能力、临床资源协调能力、研发体系效率和综合实力等因素，长期看好PD-1头 部公司，恒瑞医药、信达生物、百济神州、君实生物。
风险因素：竞争激烈导致产品价格下降，药审进度不达预期。
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