By Fineline Cube 
China-based biotech Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) has secured a pivotal regulatory milestone: the Department of Health of the Hong Kong Special Administrative Region has granted approval for TIVDAK (tisotumab vedotin). The antibody‑drug conjugate (ADC) is now cleared for treating adult patients with recurrent or metastatic cervical cancer whose disease progressed during or after chemotherapy.
Product & Technology Snapshot
- Tisotumab Vedotin (TIVDAK) – An ADC that couples a human monoclonal antibody against tissue factor (TF) with the microtubule‑disrupting agent monomethyl auristatin E (MMAE) via a protease‑cleavable linker.
- Proprietary Platform – Combines Genmab’s TF‑targeting antibody with Pfizer’s (formerly Seagen) ADC platform.
- Exclusive Greater China License – Zai Lab obtained the rights from Seagen in September 2022 (Seagen later acquired by Pfizer in 2023).
Regulatory Journey
| Milestone | Date | Description |
|---|---|---|
| U.S. FDA Approval | April 2024 | Full approval for adult patients with recurrent/metastatic cervical cancer progressing after chemotherapy. |
| Hong Kong Health Dept. Approval | 12 Mar 2025 | First‑in‑region clearance for TIVDAK, opening access to the HK market. |
| NMPA New Drug Application | March 2025 | Submission to China’s National Medical Products Administration for mainland approval. |
Market Impact
- Addressable Population – Over 120,000 cervical cancer patients in the Greater China region are projected to qualify for TIVDAK, representing a significant unmet need.
- Competitive Advantage – As the first TF‑targeted ADC approved locally, TIVDAK offers a differentiated therapeutic option against standard chemotherapy and emerging immunotherapies.
- Strategic Expansion – The Hong Kong clearance strengthens Zai Lab’s pipeline, positioning the company to pursue rapid mainland rollout and international collaborations.
Next Steps
- Commercial Roll‑Out – Zai Lab will partner with specialty pharmacies and oncology centers in Hong Kong to ensure timely patient access.
- Payer Engagement – Early discussions with insurers and the Hospital Authority will focus on reimbursement pathways and value‑based pricing.
- Global Expansion – The company will leverage its U.S. FDA approval to explore regulatory submissions in the EU and other key markets.-Fineline Info & Tech