Notes from Road - A Good Story You Don't Want to Miss

研报英文原文证据摘录

Notes from Road - A Good Story You Don't Want to Miss

May 14, 2026

(annualizing at ~$1B in US with minority of the market penetration),

we believe zoci has the potential to capture very meaningful revenues

just in 2L, as Imdelltra is moving to frontline. We view these two drugs

as complementary as opposed to competitive.

●Zai will apply for the Breakthrough Therapy Designation (BTD) for

zoci with a more mature dataset. Recall that B7-H3 ADC (Ifinatamab

deruxtecan) received BTD on a single-arm study with arguably less

competitive data than zoci.

●The interim analysis of the Ph3 would include ~100 patients/arm (could

be as early as 2Q27, by our estimate) and can only be done after

completing patient enrollment (75% enrollment by YE). The ORR and

DOR would support Accelerated Approval, while the OS supports the

full approval. The study is overpowered for the ORR endpoint, given

zoci's 68.4% ORR vs. ~20% from chemotherapy. The 200 patients are

mostly required for safety evaluation per the FDA.

●The 1L combination data update in 2H could be a meaningful catalyst

for zoci. Zai is evaluating zoci with checkpoint inhibitor +/- chemo.

Other combinations are also possible (e.g., with Imdelltra). The bottom

line is Zai will finalize a Ph3 1L trial and initiate by YE.

●The expansion into neuroendocrine tumors could be a ~$500M

opportunity. Zai is in active dialogue with the FDA on a pivotal study,

which could be a single-arm study or a randomized-control trial design.

This could be a high unmet need, fast-to-market indication for zoci.

●For an in-depth look at Zai's oncology pipeline see our webinar note

here. Please reach out if you want a recording of the webinar.

Growing excitement over ZL-1503 (IL13/IL31Ra) in atopic dermatitis (AD)