Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has formed a collaboration with US-based biotech Seagen Inc. (Nasdaq: SGEN) to license development and commercialization rights in Greater China (including mainland China, Hong Kong, Taiwan, and Macau) to Tivdak (tisotumab vedotin). This strategic partnership aims to bring this innovative antibody-drug conjugate (ADC) to patients in the region.
Deal Details
Zai Lab is making an immediate payment of $30 million and has committed to undisclosed milestones and tiered royalties on future sales of the drug in the territory. Tivdak, developed through a collaboration between Seagen and Danish biotech Genmab A/S, became the first and only ADC to win approval in the US in 2021 for treating recurrent or metastatic cervical cancer in patients with disease progression on or after chemotherapy.
Development and Commercialization
Tivdak was developed with Genmab supplying the human monoclonal antibody directed to tissue factor (TF), while Seagen applied its ADC expertise using a protease-cleavable linker to covalently attach the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. The upfront, milestone, and future royalty payments from Zai will be split evenly between Seagen and Genmab.
Regulatory and Clinical Progress
Tivdak’s 2021 cervical cancer approval in the US was granted under an accelerated pathway, with the Phase III innovaTV 301 trial ongoing to confirm its efficacy. Seagen and Genmab are also conducting trials for Tivdak as a first-line cervical cancer treatment and exploring its potential in other solid tumor types, including colorectal, non-small cell lung, and pancreatic cancers.
Future Outlook
This collaboration between Zai Lab and Seagen marks a significant step in expanding Tivdak’s reach to patients in Greater China. With Zai Lab’s strong presence in the region and Seagen’s expertise in ADC development, the partnership is well-positioned to drive the drug’s development and commercial success.-Fineline Info & Tech
