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Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

- European Medicines Agency’s Committee for Orphan Medicinal Products recognized zoci’s preliminary clinical data as suggestive of a clinically relevant advantage over currently authorized therapies in relapsed or refractory extensive-stage small cell lung cancer (SCLC)

- SCLC is the most significant pulmonary neuroendocrine carcinoma (NEC), affecting an estimated 375,000 patients annually worldwide, with limited treatment options

- EMA designation for zoci in pulmonary NECs closely follows receipt of Fast Track designation from the U.S. Food and Drug Administration for zoci in extrapulmonary neuroendocrine carcinomas (epNECs) and promising data presented at the AACR Annual Meeting in April 2026

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Tue, 16 Jun 2026 07:00:00 -0400

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

Mon, 08 Jun 2026 20:34:00 -0400

- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China

- TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation

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

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

Mon, 08 Jun 2026 20:34:00 -0400

- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China

- TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation

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

Mon, 08 Jun 2026 20:34:00 -0400

- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China

- TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation

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

Mon, 08 Jun 2026 20:34:00 -0400

- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China

- TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation

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

Mon, 08 Jun 2026 20:34:00 -0400

- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China

- TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation