Zai Lab Limited ZLAB
Zai Lab Limited (Nasdaq: ZLAB) is an oncology drug developer. Its lead program, Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC), is in Phase 3 for First-line extensive-stage small cell lung cancer (1L ES-SCLC). Its next catalyst on record is Povetacicept (partner Vertex): FDA PDUFA action date for accelerated approval BLA in IgAN (November 30, 2026).
Upcoming catalysts
- November 30, 2026Povetacicept (partner Vertex) — FDA PDUFA action date for accelerated approval BLA in IgAN
the FDA accepted its BLA submission for pove for accelerated approval in adults with IgAN, with a PDUFA target action date of November 30, 2026
Next further out: Zocilurtatug Pelitecan (Zoci) — Initiation of global Phase 3 study in 1L ES-SCLC (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ZEJULA (niraparib) | Oncology (maintenance therapy) | small molecule | Approved |
| VYVGART / VYVGART Hytrulo (efgartigimod) | Myasthenia gravis | antibody | Approved |
| NUZYRA (omadacycline) | Infectious disease | small molecule | Approved |
| OPTUNE | Glioblastoma | device-combination | Approved |
| QINLOCK (ripretinib) | Gastrointestinal stromal tumors | small molecule | Approved |
| XACDURO | Infectious disease | small molecule | Approved |
| AUGTYRO | NTRK fusion-positive solid tumors | small molecule | Approved |
| KarXT (xanomeline-trospium) | Schizophrenia | small molecule | Approved |
| Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC) | First-line extensive-stage small cell lung cancer (1L ES-SCLC) | antibody | Phase 3 |
| Efgartigimod (FcRn) - Myositis | Autoimmune myositis (IMNM and DM) | antibody | Phase 3 |
| ZL-1503 (IL-13/IL-31Rα) | Atopic dermatitis | biologic-other | Phase 1 |
Recent results and decisions
- Nov 5, 2026positive Zoci 1.6 mg/kg plus atezolizumab showed 81.8% confirmed ORR and estimated 81.9% six-month PFS rate in 1L ES-SCLC with favorable tolerability.
zoci 1.6mg/kg plus atezolizumab demonstrated an 81.8% confirmed response rate and an encouraging 81.9% six-month progression-free survival rate, with a favorable tolerability profile
Filing - Nov 5, 2026completed enrollment Zai Lab completed enrollment in Phase 3 registrational study of elegrobart for thyroid eye disease in China, with topline results expected in 2027.
Zai Lab completed enrollment in the Phase 3 registrational study for the treatment of thyroid eye disease in China.
Filing - Oct 23, 2026n/a Zai Lab plans to submit IND for ZL-1311 in the U.S. by YE'26.
Submit an IND application in the U.S. by YE'26 and initiate a global Phase 1 study in 1H'27
Filing
20 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.