ZLAB Zai Lab

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.