诺诚健华-B(09969.HK)：奥布替尼两项淋巴瘤适应症获批，纳入港股通期待估值修复，维持“审慎增持”评级，目标价21.49港元
机构：兴业证券
评级：审慎增持
目标价：21.49 港元
投资要点
事件：近日，（1）国家药监局批准公司的1类创新药奥布替尼（商品名：宜诺凯）上市，用于治疗既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者和既往至少接受过一种治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。（2）公司股票调入港股通股票范围。
奥布替尼临床数据优异，较已获批BTK抑制剂有更精准的靶点选择性：公司在美国血液学协会（ASH）年会上公布奥布替尼治疗r/rCLL/SLL和r/rMCL的临床数据，结果显示优异的ORR和安全性。奥布替尼在支架中心设计为单环，而不是伊布替尼等分子的稠合双环核心。得益于此，奥布替尼具有更精准的靶向选择性，从而带来更低的脱靶副作用，如房颤、大出血、腹泻等。
奥布替尼针对多种B细胞淋巴瘤及自免疾病的试验稳步推进：除了CLL/SLL及MCL，公司亦在推进MZL、CNSL、WM、DLBCL以及一线治疗CLL/SLL等临床试验。基于奥布替尼的高选择性、良好的安全性以及可透过血脑屏障的特性，公司已在美国启动针对复发缓解型多发性硬化症（RRMS）的国际多中心2期临床试验。目前尚无BTK抑制剂获批治疗MS，进度最快的为赛诺菲、默克和罗氏，均处于3期临床阶段。根据Frost&Sullivan，全球MS市场超过230亿美元，预计2030年超过480亿美元。奥布替尼针对SLE的2a期临床正在国内开展。SLE现有治疗选择有限，唯一获批生物药贝利尤单抗疗效有限且需要注射给药，存在巨大的临床未满足需求。公司商业化队伍已准备就绪，能够覆盖全国300家顶级医院。预计奥布替尼明年将为公司贡献较显著的收入。后续多项B细胞淋巴瘤适应症的获批以及在自身免疫性疾病领域的开拓，有望推动奥布替尼的销售不断跨上台阶。
纳入港股通提升流动性，有望实现价值重估：公司股票成功纳入港股通，成为上月末港股通纳入规则调整后的第一批受益标的之一。结合近期公司核心产品奥布替尼获批上市，基本面向好，调入港股通后，有望短期内给公司带来增量资金、提高流动性，公司股票有望实现估值修复。
盈利预测与估值：奥布替尼获批稍早于预期，预计2021年初可正式上市销售。我们维持此前的盈利预测，预测2020-2022年营业收入分别为1.43、203.97和459.86百万元，同比增长15.00%、14123.08%和125.46%；净利润分别为-458.15、-473.41和-442.60百万元。维持目标价21.49港元，维持“审慎增持”评级。
风险提示：奥布替尼研发进度和销售低于预期，管线产品的竞争超过预期，研发投入过大导致资金短缺。
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