![](\"https:\/\/mms.businesswire.com\/media\/20260608963481\/en\/1968627\/5\/ZaiLab_EN_logo_-XL-RGB.jpg\"){kind=logo}
<\/a><\/a>\nThe NMPA approval follows regulatory approvals in the United States, Japan, European Union, United Kingdom, Macau (China), and Hong Kong (China), underscoring the broad global clinical evidence supporting TIVDAK availability in China. The indication statement for TIVDAK differs slightly by region.<\/p>
\n\u201cCervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer,\u201d said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. \u201cCoupled with the previous global approvals of TIVDAK for this disease, the China BLA approval further validates the robust global evidence of clinical benefit for this population of advanced patients with limited therapeutic options.\u201d<\/p>
\nResults from the Phase 3 innovaTV 301 clinical trial, including data from the China subpopulation of this study that Zai Lab conducted, supported global approval of TIVDAK:<\/p>
- \n
- \nIn the global study, the trial met its primary endpoint of OS in the intention-to-treat (ITT) population of the global study (HR=0.70; 95% CI: 0.54\u20130.89; two-sided p=0.0038). The China subpopulation showed consistent results, with a clinically meaningful improvement in OS (HR: 0.55, 95% CI: 0.27- 1.15), corresponding to a 45% reduction in the risk of death compared to chemotherapy.1<\/sup><\/li>\n
- \n54.1% of the China subpopulation received prior anti-PD(L)1 therapy, the current standard of care for second-line treatment of cervical cancer. TIVDAK showed consistent OS benefit trends irrespective of prior immunotherapy exposure.2<\/sup><\/li>\n
- \nThere were no new safety signals identified among patients in the China subpopulation who received TIVDAK. The most common Grade \u22653 treatment-emergent adverse events (TEAEs) in the global study were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%).1<\/sup> The most common Grade \u22653 TEAEs in the China subpopulation were anemia (11.4%), cough (5.7%), and malaise (5.7%).2<\/sup><\/li>\n<\/ul>
\n\u201cTreatment options are very limited for cervical cancer patients once recurrence or metastasis occurs,\u201d said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology of National Cancer Center \/ Cancer Hospital Chinese Academy of Medical Sciences. \u201cConsistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy.\u201d<\/p>
\nZai Lab will leverage the company\u2019s extensive experience and expanding presence in the Chinese gynecologic oncology community, as well as commercial synergies with its ZEJULA\u00ae<\/sup> team, to bring TIVDAK to patients in China.<\/p>
\nAbout Cervical Cancer in China<\/b><\/p>
\nAn estimated 150,000 new cases of cervical cancer occur annually in China3<\/sup>. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients.<\/p>
\nAbout Tisotumab Vedotin<\/b><\/p>
\nTisotumab vedotin (approved under the brand name TIVDAK\u00ae<\/sup> in the EU, U.K., U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab\u2019s human monoclonal antibody directed to tissue factor (TF) and Pfizer\u2019s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.<\/p>
\nTIVDAK received full approval from the U.S. Food and Drug Administration in April 2024, and U.S. approval was first secured in September 2021 under the accelerated approval pathway for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval has also been received in Japan, European Union, Macau (China), and Hong Kong (China) for the same indication.<\/p>
\nZai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, for TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). Zai Lab is solely responsible for the development, supply, and commercialization of TIVDAK in Greater China.<\/p>
\nAbout Zai Lab<\/b><\/p>
\nZai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.<\/p>
\nFor additional information about Zai Lab, please visit www.zailaboratory.com<\/a> or follow us at www.twitter.com\/ZaiLab_Global<\/a>.<\/p>
\nZai Lab Forward-Looking Statements<\/b><\/p>
\nThis press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in Greater China, the potential benefits of TIVDAK, and the potential treatment of cervical cancer. These forward-looking statements may contain words such as \u201caim,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cforecast,\u201d \u201cgoal,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpossible,\u201d \u201cpotential,\u201d \u201cwill,\u201d \u201cwould,\u201d and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.<\/p>
\nOur SEC filings can be found on our website at www.zailaboratory.com<\/a> and the SEC\u2019s website at www.sec.gov<\/a>.<\/p>
- \n54.1% of the China subpopulation received prior anti-PD(L)1 therapy, the current standard of care for second-line treatment of cervical cancer. TIVDAK showed consistent OS benefit trends irrespective of prior immunotherapy exposure.2<\/sup><\/li>\n