Zai Lab Limited

Zai Lab's Zocilurtatug Pelitecan (Zoci, Formerly ZL-1310) Demonstrates High Response Rates, Encouraging Durability and Well-Tolerated Safety Profile in First-Line Extensive-Stage Small Cell Lung Cancer

Zai Lab reported first Phase 1b data for zocilurtatug pelitecan (zoci, formerly ZL-1310) plus atezolizumab in first-line extensive-stage small cell lung cancer, showing a confirmed objective response rate of 81.8% (27/33) and an estimated 6-month PFS rate of 81.9% at the 1.6 mg/kg RP3D. In patients with at least six months of follow-up (n=15), median PFS and duration of response were not yet reached after a median 10 months of follow-up, and the doublet showed a favorable safety profile with Grade ≥3 zoci-related AEs in only 9.1% of patients versus roughly 60% for current platinum-based standard of care. The triplet with carboplatin showed a 92.3% ORR (n=13) but materially higher Grade ≥3 TEAEs (76.9%), positioning the chemo-free doublet as the lead strategy. Zai Lab plans to initiate a global randomized Phase 3 study in 1L ES-SCLC by year-end 2026; zoci is on track to become the company's first global oncology launch.

•9d ago

Zai Lab to Present Data From First Clinical Trial Evaluating ZL-1503, an IL-13/IL-31Rα Bispecific Antibody, for Atopic Diseases

Zai Lab will present first clinical trial data for ZL-1503, its internally developed IL-13/IL-31Rα bispecific antibody, at the ACAAI 2026 Annual Scientific Meeting on November 13 in Phoenix. The Phase 1/1b first-in-human trial (NCT07235384) in healthy volunteers will show single-dose pharmacokinetics, pharmacodynamic biomarker data, and initial safety and immunogenicity findings. ZL-1503 is positioned as a potentially first-in-class, long-acting treatment for moderate-to-severe atopic dermatitis; the company will host an investor call on November 13 at 8:00 a.m. ET to discuss the data and trial plans.

•18d ago

Zai Lab to Present First Global Data from Clinical Trial Evaluating Zocilurtatug Pelitecan (Zoci) As First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Zai Lab will present first global data for zocilurtatug pelitecan (zoci), a DLL3-targeting ADC, in first-line extensive-stage small cell lung cancer at the ESMO Congress 2026 in Madrid on October 26. The data come from the Phase 1b/1c part of Study ZL-1310-001 evaluating zoci plus atezolizumab with or without carboplatin; management touts a potential best-in-class safety profile and intracranial efficacy. The company scheduled an investor call for October 23 to discuss the ESMO data and zoci clinical trial plans, framing zoci as a potential backbone ADC in first-line combination regimens.

•1mo ago

Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis

Zai Lab and partner argenx reported positive topline results from the Phase 3 ALKIVIA trial of VYVGART Hytrulo for autoimmune myositis, meeting the primary endpoint of Total Improvement Score (TIS) at Week 52 in the combined IMNM and DM population (p=0.0011). Patients treated with efgartigimod showed a 15.4 point greater improvement in TIS versus placebo, with benefits sustained through 52 weeks. The study also met statistical significance in the IMNM subtype (p=0.0048), marking the first Phase 3 program to demonstrate efficacy in this indication which currently has no approved therapies. Zai Lab holds an exclusive license for VYVGART in Greater China and plans to advance regulatory submissions to bring this targeted treatment option to patients in the region.

•2mo ago

Zai Lab Announces Second Quarter 2026 Financial Results and Recent Corporate Updates

Zai Lab reported Q2 2026 total revenue of $106.3 million, with net product revenue growing 11% sequentially to $105.8 million driven by volume gains for VYVGART and stabilization of ZEJULA. The pipeline delivered multiple catalysts, including FDA Orphan Drug and Fast Track designations for zoci in neuroendocrine carcinomas, and the approval of TIVDAK in China for cervical cancer. Management guided to potential U.S. regulatory submissions for zoci in 2027 and anticipates initial Phase 1 data for zoci and ZL-1503 in the second half of 2026.

•2mo ago

U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs)

Zai Lab announced that the FDA granted Orphan Drug Designation to its potential first-in-class DLL3-targeting ADC, zocilurtatug pelitecan (zoci), for the treatment of neuroendocrine carcinomas. This designation provides development incentives, including tax credits and potential seven-year market exclusivity upon approval, complementing prior Fast Track and Orphan Drug designations in SCLC and epNECs. The company plans to initiate three registration-enabling studies for zoci across SCLC and epNECs by the end of 2026 to address the high unmet need in these aggressive malignancies.

•2mo ago