Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 103

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 103
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, in 1L gastric or GEJ cancer with FGFR2b overexpression. In addition, we are participating in the Greater China portion of the global Phase III FORTITUDE-102 study of bemarituzumab in combination with nivolumab and chemotherapy versus placebo in combination with nivolumab and chemotherapy in 1L gastric or GEJ cancer with FGFR2b overexpression. We estimate an annual incidence of around 95,000 1L gastric cancer patients with FGFR2b overexpression in China.

TIVDAK (Tisotumab Vedotin)

TIVDAK is an ADC composed of Genmab’s human monoclonal antibody directed against cell surface tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches MMAE to the antibody. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death of actively dividing cells. In vitro, TIVDAK also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. We have an exclusive license from Seagen (a company later acquired by Pfizer) to develop and commercialize tisotumab vedotin in Greater China. 

We are evaluating TIVDAK for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK received full approval in the United States for this indication in April 2024 based on results from the global, randomized Phase III innovaTV 301 clinical trial, which met its primary endpoint of OS. The key 

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secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance. The safety profile of TIVDAK in innovaTV 301 was consistent with the known safety profile of TIVDAK as presented in the U.S. prescribing information, and no new safety signals were observed. In January 2025, we announced positive topline results from the China subpopulation of the innovaTV 301 study, which were consistent with those in the global population, and we intend to submit an NDA to the NMPA in the first quarter of 2025. We estimate that there are around 150,000 new cases of cervical cancer each year in China.

Additional Indications for OPTUNE (TTFields)

As discussed in Our Commercial Products and Operations, we have an exclusive license from NovoCure