Zai Lab’s TIVDAK Approval in Hong Kong and the Path to Mainland China Expansion: A Catalyst for Oncology Growth in Greater China

Zai Lab’s recent approval of TIVDAK (tisotumab vedotin-tftv) in Hong Kong marks a pivotal moment in its oncology strategy, positioning the company to capitalize on a high-unmet-need therapeutic niche in cervical cancer. Approved on September 2, 2025, for the treatment of recurrent or metastatic cervical cancer in patients who have progressed after chemotherapy, TIVDAK is now the first antibody-drug conjugate (ADC) therapy in the region for this indication, offering a clinically meaningful survival benefit [1]. This regulatory win not only underscores Zai Lab’s innovation in women’s cancers but also sets the stage for its next challenge: securing approval in Mainland China, a market with significantly higher patient volume and growth potential.

The regulatory pathway for TIVDAK in Mainland China is already underway. In March 2025, Zai Lab submitted a Biologics License Application (BLA) to the National Medical Products Administration (NMPA), which was accepted for review [1]. While the NMPA has not yet disclosed a timeline for approval, historical trends for innovative oncology therapies suggest a 6–12 month review period, potentially leading to a decision by late 2025 or early 2026 [2]. This timeline is critical for investors, as Mainland China represents a market with over 100,000 new cervical cancer cases annually, compared to Hong Kong’s roughly 500 cases per year.

The clinical data supporting TIVDAK’s regulatory submissions further strengthens its commercial case. In the China subpopulation of the Phase 3 innovaTV 301 trial, TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy, with median overall survival not reached in the TIVDAK group [3]. These results, consistent with the global trial, highlight the drug’s robust efficacy and align with the NMPA’s increasing openness to accelerated approvals for therapies with substantial unmet needs.

From a commercial perspective, Zai Lab’s existing infrastructure in Hong Kong provides a blueprint for rapid market access in Mainland China. The company has emphasized its ability to leverage its commercial capabilities to ensure timely patient access once regulatory hurdles are cleared [3]. This is particularly relevant in the context of China’s evolving healthcare landscape, where payers and providers are increasingly prioritizing innovative therapies with proven outcomes.

For investors, the dual catalysts of TIVDAK’s Hong Kong approval and its pending Mainland China approval represent a significant inflection point for Zai Lab’s oncology portfolio. The drug’s first-in-class status in cervical cancer, combined with its demonstrated clinical benefits, positions it to capture market share in a competitive but underserved space. Moreover, the regulatory momentum in Greater China—where Zai Lab has already established a strong presence—could amplify the drug’s commercial impact, particularly if pricing and reimbursement negotiations align with its value proposition.

In conclusion, Zai Lab’s TIVDAK approval in Hong Kong is not just a regulatory win but a strategic milestone that validates the company’s focus on women’s cancers and ADC innovation. As the BLA progresses through the NMPA review process, the drug’s potential to address a large patient population in Mainland China could drive substantial revenue growth and reinforce Zai Lab’s position as a leader in oncology within Greater China.

Source:
[1] Zai Lab Announces Approval of TIVDAK® for Patients with Recurrent or Metastatic Cervical Cancer in Hong Kong, https://www.biospace.com/press-releases/zai-lab-announces-approval-of-tivdak-for-patients-with-recurrent-or-metastatic-cervical-cancer-in-hong-kong
[2] Zai Lab's Strategic Expansion in Oncology: TIVDAK's Regulatory Momentum in Greater China, https://www.ainvest.com/news/zai-lab-strategic-expansion-oncology-tivdak-regulatory-momentum-greater-china-2509/
[3] Zai Lab Announces Positive Topline Results of TIVDAK in the China Subpopulation of the innovaTV 301 Trial, https://ir.zailaboratory.com/zh-hant/news-releases/news-release-details/zai-lab-announces-positive-topline-results-tivdak-china/