复宏汉霖-B(02696.HK)：曲妥珠单抗在欧盟获批，临床价值国际化变现，维持“买入”评级，目标价78 港元
机构：光大证券
评级：买入
目标价：78 港元
事件：
公司的商务合作伙伴 Accord Healthcare Limited（以下简称“Accord”）提交的 HLX02（曲妥珠单抗，欧盟商品名：Zercepac）用于HER阳性早期乳腺癌、HER2 阳性的转移性乳腺癌，以及未经治疗的HER2 阳性转移性胃癌或胃食管交界处腺癌治疗的营销授权申请获欧盟委员会批准。HLX02 在所有欧盟成员国及冰岛、列支敦士登和挪威获得集中上市许可。
点评：
中国首个抗体类似药出口欧盟，跻身国际一流抗体药行列
Zercepac 是中国首个出口到欧盟的抗体类似药，该产品获批标志着公司的产品质量已达到国际一流水平，是国际化布局的里程碑。Zercepac 是欧洲第 6个获批的曲妥珠单抗类似药，在欧洲的销售工作由合作伙伴 Accord 负责。Accord 在欧洲仿制药销售排名前三，肿瘤领域仿制药销售排名第一，有 8500+仿制药在售，覆盖85+国家。公司除4050万美元（原协议）+308万美元（新增规格）的首付款和里程碑付款之外，还将按净销售额产生利润的15%-26.5%获得许可使用费。
广泛建立合作关系，国际化变现临床价值
公司的曲妥珠单抗除授权Accord欧洲权益之外，还授权Mabxience在阿根廷、乌拉圭、巴拉圭，Jacobson 在香港和澳门，Cipla 在澳大利亚、新西兰、哥伦比亚和马来西亚的独家商业化权利，将曲妥珠单抗类似药的临床价值在尽可能大的范围内变现为商业价值。
国内进度领先，竞争格局优良
公司的曲妥珠单抗在国内2019年4 月提交上市申请，有望在近期获批上市，成为国内首个曲妥珠单抗类似药。截至2020.7.30，尚未有其他企业提交曲妥珠单抗类似药的上市申请，公司的曲妥珠单抗将拥有较长的时间窗口，短期内竞争格局较为优良，价格战压力小，有望迅速提升市占率。
盈利预测、投资评级和估值：
公司是中国抗体药龙头之一，在单抗类似药和国际化方面进度领先，综合竞争实力强劲。考虑利妥昔单抗增加适应症（见附录），上调 2020-2022 年的收入预测为7.73/18.33/31.43 亿元（原预测为5.98/15.08/28.43亿元），同比增长 750.6%/137.1%/71.5%；归母净利润-6.81/ -0.52/6.71 亿元，对应 EPS 为-1.25/-0.10/1.24 元。考虑类似药的放量节奏较快，我们调整了部分药物的达峰时间预测，并新增了EGFR 改良型创新药HLX07的估值预测，测算得到公司估值为381 亿元，按照2020.7.30 港元兑人民币汇率0.9020，对应 423 亿港元，目标价相应上调为78 港元。维持“买入”评级。
风险提示：研发进度不达预期的风险；销售情况不达预期的风险；全球化拓展不达预期的风险。
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