SHANGHAI, China & CAMBRIDGE, Massachusetts, USA – June 9, 2026
Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for TIVDAK® (tisotumab vedotin for injection), marking the first antibody-drug conjugate (ADC) approved in China for the treatment of adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy. The milestone represents a major advancement for women facing one of the most challenging forms of gynecologic cancer and further strengthens the growing role of antibody-drug conjugates in oncology. The approval is supported by results from the global Phase 3 innovaTV 301 clinical trial, which demonstrated a statistically significant overall survival benefit compared with chemotherapy, including encouraging outcomes in Chinese patients. With cervical cancer remaining a leading cause of cancer-related death among women in China, the introduction of TIVDAK provides physicians and patients with an innovative new treatment option at a time when therapeutic choices remain limited for advanced disease.
Phase 3 Study Demonstrates Significant Survival Advantage
The approval was based on findings from the pivotal innovaTV 301 Phase 3 trial, a global randomized study evaluating TIVDAK against standard chemotherapy in patients with previously treated recurrent or metastatic cervical cancer. The study successfully achieved its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) for patients receiving TIVDAK. In the global intent-to-treat population, TIVDAK reduced the risk of death by 30% compared with chemotherapy, delivering a clinically meaningful survival benefit. Results were also consistent among patients enrolled in China, where the treatment demonstrated a 45% reduction in the risk of death compared with chemotherapy.
Importantly, benefits were observed regardless of prior exposure to PD-(L)1 inhibitors, which have become a standard component of treatment for advanced cervical cancer. These findings reinforce the potential of TIVDAK to address a critical unmet need in patients whose disease has progressed despite previous therapies and who often face poor clinical outcomes and limited treatment alternatives.
First ADC Approved for Previously Treated Cervical Cancer in China
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TIVDAK is an antibody-drug conjugate targeting tissue factor (TF), a protein commonly expressed on the surface of cervical cancer cells. The therapy combines a highly specific monoclonal antibody with a potent cytotoxic payload, enabling targeted delivery of cancer-killing treatment directly to tumor cells while minimizing exposure to healthy tissue. Following binding to tissue factor, the drug is internalized by cancer cells, where it releases its payload and triggers cell death. Beyond direct tumor killing, TIVDAK may also stimulate immune-mediated anti-cancer activity through antibody-dependent cellular mechanisms.
The approval makes TIVDAK the first ADC available in China specifically for previously treated recurrent or metastatic cervical cancer, representing a significant expansion of treatment options within gynecologic oncology. The product has already gained regulatory approvals in the United States, European Union, Japan, United Kingdom, Hong Kong, and Macau, highlighting broad international confidence in its clinical value.
Expanding Treatment Options for Women with Advanced Cervical Cancer
An estimated 150,000 new cases of cervical cancer are diagnosed annually in China, creating a substantial healthcare burden and emphasizing the need for innovative therapies capable of improving survival outcomes. Patients whose disease recurs or metastasizes following chemotherapy often have limited treatment opportunities, making the arrival of new therapeutic classes particularly important. Zai Lab plans to leverage its growing oncology infrastructure and commercial expertise to rapidly expand access to TIVDAK across China.
Company leadership emphasized that the approval validates the robust global clinical evidence supporting the therapy while demonstrating the company’s commitment to bringing innovative cancer treatments to patients with high unmet medical needs. As antibody-drug conjugates continue transforming cancer care worldwide, the approval of TIVDAK represents an important milestone for precision oncology and may help redefine treatment expectations for women living with advanced cervical cancer.
Source: Zai Lab press release
