Company: ZLAB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001628280-25-023411
Chunk: 75

Company: Zai Lab Ltd
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 8
Chunk 75
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 net losses and negative cash flows from our operations. Substantially all of our losses have resulted from funding our research and development programs and selling, general and administrative costs associated with our operations. Developing high quality product candidates requires significant investment in our research and development activities over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. Our ability to generate profits and positive cash flow from operations depends upon our ability to successfully market our commercial products and to successfully expand the indications for these products and develop and commercialize our other product candidates. As discussed further below, we expect to continue to incur substantial costs related to our research and development and commercialization activities.

As we pursue our corporate strategic goals, we anticipate that our financial results will fluctuate from quarter to quarter and year to year depending in part on the balance between the success of our commercial products and the level of our research and development expenses. We cannot predict whether or when our product candidates will receive regulatory approval. Further, if we receive such regulatory approval, we cannot predict whether or when we may be able to successfully commercialize such products or whether or when such products may become profitable. 

Recent Developments 

Commercial Products 

Net product revenue was $105.7 million for the 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