ZLAB Zai Lab

zocilurtatug pelitecan · NCT07707895 registry update

countries: {'total_sites': 27, 'us_sites': 4} → {'total_sites': 27, 'us_sites': 3}

Zai Lab Zocilurtatug Pelitecan + Atezolizumab Phase 1b Shows 81.8% ORR in 1L ES-SCLC

Zai Lab reported positive Phase 1b data for zocilurtatug pelitecan (zoci) plus atezolizumab in first-line ES-SCLC, with 81.8% confirmed ORR, 81.9% 6-month PFS rate, and mPFS/mDOR not reached at 10-month median follow-up. The regimen was well-tolerated with 9.1% Grade ≥3 zoci-related AEs. This supports initiation of a global Phase 3 trial of zoci plus IO by year-end 2026.

Zai Lab presents ESMO 2026 data for zoci (ZL-1310) in 1L ES-SCLC

Zai Lab presented updated Phase 1 data at ESMO 2026 showing 81.8% ORR and 81.9% 6-month PFS rate for zoci plus atezolizumab in 1L ES-SCLC, with rapid/deep responses, emerging durability, intracranial activity, and favorable safety (13% grade ≥3 TRAEs). This supports ongoing Phase 3 planning for the doublet in frontline SCLC.

Zai Lab raises $250M PIPE to fund zocilurtatug pelitecan (zoci) development

Zai Lab entered a securities purchase agreement for a $250 million private placement of ADSs led by TCGX and other investors. Net proceeds will primarily support continued global development of its DLL3-targeting ADC zocilurtatug pelitecan (zoci) in ES-SCLC. The financing is expected to close in October 2026.

zocilurtatug pelitecan · NCT07218146 registry update

countries: {'total_sites': 155, 'us_sites': 37} → {'total_sites': 165, 'us_sites': 37}

Zai Lab to Present Phase 1/1b Data for ZL-1503 at ACAAI 2026

Zai Lab will present first-in-human Phase 1/1b data from healthy volunteers for internally developed ZL-1503, including PK, PD on AD biomarkers, safety and immunogenicity, at the ACAAI 2026 Annual Scientific Meeting on November 13, 2026. This marks the first clinical data disclosure for the bispecific antibody in development for atopic dermatitis and related diseases.

Zenas BioPharma presents new obexelimab Phase 3 OLE data in IgG4-RD at IgG4 Symposium

New data from the Phase 3 INDIGO open-label extension showed sustained flare-free probability (0.93/0.87) and low glucocorticoid use with obexelimab in IgG4-RD. Additional analyses demonstrated reduced glucocorticoid toxicity versus placebo and preserved vaccine responses after a treatment-free window. These results add to clinical evidence for obexelimab as a reversible, steroid-sparing B-cell inhibitor.

Zai Lab to Present First Global Zoci Data at ESMO 2026 in 1L ES-SCLC

Zai Lab will present first global Phase 1b/1c data for zocilurtatug pelitecan (zoci) plus atezolizumab with or without carboplatin as first-line treatment for extensive-stage small cell lung cancer at the ESMO Congress 2026. The poster will add to evidence supporting zoci as a potential backbone ADC in first-line regimens.

zocilurtatug pelitecan · NCT07707895 registry update

countries: {'total_sites': 26, 'us_sites': 3} → {'total_sites': 27, 'us_sites': 4}

Zenas: FDA accepts obexelimab BLA for IgG4-RD; PDUFA May 27, 2027

FDA accepted the obexelimab BLA for IgG4-RD with a PDUFA target action date of May 27, 2027. The acceptance triggers a $30 million milestone payment under the Xencor agreement and positions the company for potential U.S. approval and subsequent EMA and PMDA filings. The Phase 3 INDIGO data supporting the BLA showed a 56% reduction in flare risk versus placebo.

Zai Lab receives FDA ODD for zocilurtatug pelitecan in NECs

FDA granted Orphan Drug Designation to zocilurtatug pelitecan for neuroendocrine carcinomas in July 2026. EMA also granted ODD for pulmonary NECs in June 2026. FDA Fast Track Designation for epNECs was received in May 2026, marking the second Fast Track for this asset.

Zai Lab: China NMPA approves TIVDAK for recurrent/metastatic cervical cancer

China NMPA approved the BLA for TIVDAK (tisotumab vedotin) for adult patients with recurrent or metastatic cervical cancer after chemotherapy. The approval is supported by the global Phase 3 innovaTV 301 trial showing OS benefit (HR 0.70) and consistent China subpopulation results (HR 0.55). TIVDAK becomes the first ADC approved in China for this indication.

Zenas BioPharma submits BLA for obexelimab in IgG4-RD

Zenas BioPharma has submitted a BLA to the FDA for obexelimab in IgG4-RD, supported by positive Phase 3 INDIGO trial data. The submission advances the asset from clinical development to regulatory review. The company highlighted the statistically significant 56% reduction in flare risk (HR 0.44, p=0.0005) and favorable safety profile.

Zenas BioPharma: Phase 3 INDIGO obexelimab data at EULAR 2026

The company will present full safety and efficacy results from the registrational Phase 3 INDIGO trial of obexelimab in IgG4-RD at the EULAR 2026 Congress on June 4, 2026. The trial already met its primary endpoint and all four key secondary endpoints with high statistical significance. This marks the first public disclosure of the detailed Phase 3 data package.

Zenas BioPharma plans obexelimab BLA submission for IgG4-RD this quarter

The company confirmed its marketing applications for obexelimab in IgG4-RD remain on track, with a BLA submission to the FDA expected this quarter and an MAA to the EMA in H2 2026. Phase 3 INDIGO trial results will be presented at EULAR 2026 on June 4.

Zenas BioPharma plans obexelimab BLA submission for IgG4-RD in Q2 2026

Following positive Phase 3 INDIGO results, Zenas now expects to submit a BLA to FDA in Q2 2026 and an MAA to EMA in H2 2026 for obexelimab in IgG4-RD. The filing timeline is based on the registrational trial meeting its primary and all key secondary endpoints with high statistical significance.

Zai Lab advances zoci into three registration-enabling studies in SCLC and NECs

Zai Lab initiated a global Phase 3 study in 2L+ SCLC and the Phase 2 portion of a Phase 1b/2 study in extrapulmonary NECs. The company now plans three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs, with three data readouts expected in 2026.

Zenas reports positive Phase 3 INDIGO topline for obexelimab in IgG4-RD

The Phase 3 INDIGO trial met its primary endpoint with a 56% reduction in IgG4-RD flare risk (HR 0.44, p=0.0005) and all four key secondary endpoints. Zenas now plans to file a BLA with the FDA in Q2 2026 and an MAA with the EMA in H2 2026.

Zai Lab initiates global registrational study of zocilurtatug pelitecan in 2L+ ES-SCLC

Zai Lab started a global registrational monotherapy trial of zocilurtatug pelitecan in second-line+ extensive-stage small cell lung cancer. Updated Phase 1 data showed a 68% response rate at the 1.6 mg/kg dose and a 6.1-month median duration of response, supporting the pivotal move. The safety profile was favorable with only 13% Grade ≥3 treatment-related adverse events and no Grade ≥2 ILD or discontinuations.