Company: ZLAB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001628280-25-023411
Chunk: 1

Company: Zai Lab Ltd
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 2
Chunk 1
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 first quarter of 2025, an increase of 21% compared to the prior year period, primarily driven by increased sales for NUZYRA, VYVGART, and ZEJULA. Increased sales for these products were supported by increased patient access supported by their listings in the NRDL. 

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

•ZL-1310 (DLL3 ADC): In April 2025, we initiated a global Phase I/II study in patients with selected solid neuroendocrine tumors, allowing us to evaluate its therapeutic potential beyond ES-SCLC.

•Tisotumab Vedotin (TIVDAK, Tissue Factor ADC): In March 2025, China’s NMPA accepted the BLA for TIVDAK for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. The BLA submission is supported by the results from the global, randomized, Phase III innovaTV 301 clinical trial and the results from the China subpopulation of this study. As reported in January 2025, the China subpopulation results were consistent with those in the global population. TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy.

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•Repotrectinib: In April 2025, China’s NMPA accepted the supplemental NDA for repotrectinib for the treatment of adult patients with NTRK+ solid tumors. The application is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.

•ZL-6201 (LRRC15 ADC): In April 2025, we presented new data at the AACR Annual Meeting 2025 reflecting that ZL-6201 efficiently internalizes within and kills tumor cells, while also exhibiting a strong bystander killing effect in the tumor microenvironment. Based on these findings, we plan to initiate IND-enabling studies of ZL-6201 as a potential treatment for patients with sarcoma and other LRRC15-positive solid tumors, such as breast cancer and other malignancies, in 2025.

•ZL-1222 (PD-1 / IL-12): In April 2025, we presented data at