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Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer

Tuesday, June 9, 2026 1 min read
Key Takeaway: Zai Lab has received approval from China's NMPA for TIVDAK (tisotumab vedotin) to treat adult patients with recurrent or metastatic cervical cancer. This approval follows the successful results of the Phase 3 innovaTV 301 clinical trial. TIVDAK is indicated for patients who have experienced disease progression after chemotherapy.

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POSITIVE FACTORS

  • NMPA approval signifies a major milestone for Zai Lab.
  • TIVDAK offers a new treatment option for cervical cancer patients.
  • Approval based on positive results from a Phase 3 clinical trial.

Full Press Release Details

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK® (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, wh

Frequently Asked Questions

What is TIVDAK approved for?

TIVDAK is approved for treating adult patients with recurrent or metastatic cervical cancer.

Which regulatory body approved TIVDAK?

TIVDAK was approved by China's National Medical Products Administration (NMPA).

What trial supported TIVDAK's approval?

The approval is based on results from the Phase 3 innovaTV 301 clinical trial.

What is the significance of this approval?

This approval provides a new treatment option for patients who progressed after chemotherapy.

Tags: ZLAB Viatris Investor Conferences Healthcare Zai Lab TIVDAK tisotumab vedotin cervical cancer NMPA
Last updated: Jun 9, 2026