下半年多个里程碑事件值得期待。 1）2025 年下半年有望向 NMPA 提交上市申请方面：贝玛妥珠单抗 （FGFR2b）预计提交用于胃癌一线治疗的上市许可申请、肿瘤电 场治疗预计提交用于一线胰腺癌治疗的上市许可申请、艾加莫德 （FcRn）预计提交艾加莫德预充式皮下注射用于 gMG 和慢性炎性 脱髓鞘性多发性神经根神经病（CIDP）的上市许可申请。 2）近期有望获得 NMPA 批准的上市许可申请方面：呫诺美林曲司 氯铵（KarXT）（M1/M4 型毒蕈碱乙酰胆碱受体激动剂）有望获批用 于精神分裂症、维替索妥尤单抗（TIVDAK，组织因子 ADC）有望获 批用于化疗期间或之后病情进展的复发或转移性宫颈癌、瑞普替 尼（ROS1/TRK）有望获批用于 NTRK 阳性实体瘤。 3）预期的临床开发和数据公布方面：ZL-1310（DLL3 ADC）用于 二线 ES-SCLC 将公布数据更新，并于 2025 年下半年启动 ZL-1310 单药治疗的全球注册性研究；用于一线 ES-SCLC ZL-1310 联用阿 替利珠单抗的剂量递增研究数据的读出。ZL-1503（IL-13/IL-31R） 将在 2025 年下半年推进启动用 ...

Investment Rating - The report maintains a positive outlook on Zai Lab with a reaffirmed full-year revenue guidance of USD 560-590 million for 2025 [1][5]. Core Insights - Zai Lab reported a net product revenue of USD 109 million in 2Q25, representing a 9% year-over-year increase, with a gross margin of 60.7% [1][5]. - The core product, efgartigimod, achieved sales of USD 26.5 million, up 14% year-over-year and 46% quarter-over-quarter, driven by extended treatment duration and improved market penetration [2][7]. - The company narrowed its net loss to USD 40.7 million from USD 80.3 million in the same quarter last year, with adjusted operating loss improving by 37% year-over-year to USD 34.2 million [1][5]. Financial Performance - The R&D expense ratio decreased to 46.0% of revenue, down 15.3 percentage points year-over-year, while SG&A expenses decreased to 64.6%, down 14.7 percentage points year-over-year [1][5]. - As of the end of 2Q25, Zai Lab had a strong cash position of USD 860 million [1][5]. Key Milestones - Anticipated milestones for 2H25 include the submission of a Biologics License Application (BLA) for bemarituzumab for first-line gastric cancer treatment and a marketing authorization application for tumor treating fields in first-line pancreatic cancer treatment [2][7]. - Initiation of a global registrational study for ZL-1310 monotherapy in second-line extensive-stage small cell lung cancer (ES-SCLC) is also planned [2][7].