Company: ZLAB
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001704292-25-000024
Chunk: 55

Company: Zai Lab Ltd
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 55
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, due to evolving competitive dynamics within the PARPi class. 

Product Candidates 

We continued to advance our product candidates through our research and development activities, including the following developments with respect to our clinical trials and regulatory approvals:

Oncology

•Zocilurtatug Pelitecan (Zoci, DLL3 ADC) (formerly ZL-1310): In October 2025, we presented updated data from the global Phase I clinical trial evaluating zoci for the treatment of patients with ES-SCLC at the AACR-NCI-EORTC International Conference. The data demonstrated a best overall response rate of 68% in 2L patients treated at the 1.6 mg/kg dose in ES-SCLC. The median duration of response was 6.1 months across all patients and is clinically meaningful in this population with advanced disease. Meaningful activity in patients with brain metastases was also observed, including an 80% response rate in patients with untreated brain metastases. The data also demonstrated a well-tolerated safety profile at 1.6 mg/kg, with Grade ≥ 3 

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treatment-related adverse events of 13%, no Grade ≥2 interstitial lung disease, and no drug discontinuations. We have initiated a global registrational study of zoci monotherapy in 2L+ SCLC.

•Tisotumab Vedotin (TIVDAK, Tissue Factor ADC): In September 2025, the Hong Kong Department of Health approved TIVDAK in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is currently under regulatory review for its Biologics License Application by the NMPA, which was accepted in March 2025.

•Bemarituzumab: In September 2025, our partner Amgen announced that the descriptive follow-up analysis of the Phase III FORTITUDE-101 clinical trial evaluating bemarituzumab in FGFR2b positive 1L gastric cancer has been completed. At the pre-specified interim analysis (the primary analysis), overall survival was significantly improved with bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone (median OS of 17.9 months versus 12.5 months). However, at the follow-up analysis, the magnitude of the previously observed survival benefit attenuated (median OS of 14.5 months versus 13.2 months