Zai Lab (ZLAB) Citi's 2025 Virtual Oncology Leadership Summit summary

Pipeline overview and strategic focus

• Diverse pipeline spans oncology, autoimmune, and neuroscience, with a strong emphasis on first- and best-in-class molecules via internal discovery and partnerships.

• Oncology programs include targeted therapies, antibody-drug conjugates (ADCs), immuno-oncology, and device collaborations.

• Key oncology assets: DLL3 ADC (ZL-1310), bemarituzumab (FGFR2b inhibitor), Tivdak (ADC for cervical cancer), and others in collaboration with major pharma partners.

• Non-oncology assets include KarXT for schizophrenia, efgartigimod for autoimmunity, and povetacicept for IgA nephropathy.

• Global and regional strategies are pursued, with a goal of 1–2 new INDs per year.

ZL-1310 (DLL3 ADC) clinical development

• ZL-1310 showed a 74% response rate in early data for small cell lung cancer, with rapid and durable responses, including in brain metastases.

• The ADC features high affinity, DAR8, and a TMALIN system enabling bystander effect and activity in low DLL3-expressing tumors.

• Regulatory discussions are ongoing for accelerated approval, with strategies including single-arm and randomized trials under FDA guidance.

• Upcoming data will include mature response rates and durability from 25+ patients, plus randomized dose optimization results.

• Frontline studies combine ZL-1310 with atezolizumab and carboplatin, aiming for chemo-sparing regimens; pivotal trials in neuroendocrine carcinoma to start soon.

Additional oncology programs

• Bemarituzumab (FGFR2b inhibitor) in partnership with Amgen is nearing phase III readout in frontline gastric cancer, with strong prior phase II results.

• LRRC15 ADC targets tumor microenvironment fibroblasts and certain sarcomas, leveraging bystander effect; IND opening this year.

• ROR1 ADC and CCR8 antibody are advancing, with ROR1 targeting solid tumors and CCR8 focusing on Treg modulation in checkpoint-resistant cancers.