Zai Lab Limited (ZLAB) Gains EMA Orphan Drug Designation for DLL3-Targeting Cancer Therapy

We recently compiled a list of the 10 Most Promising Cancer Stocks According to Wall Street Analysts. Zai Lab Limited is one of the most promising stocks on our list.

TheFly reported on June 16 that ZLAB announced that the European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the company’s potential first-in-class DLL3-targeting antibody-drug conjugate (ADC) for pulmonary neuroendocrine carcinomas (NECs). The designation followed a positive recommendation from the EMA’s Committee for Orphan Medicinal Products, recognizing the significant unmet need for new treatment options in this disease area. The decision was supported by early clinical findings in relapsed or refractory extensive-stage small cell lung cancer, suggesting zoci may provide durable responses and potential advantages compared with existing therapies. The designation may also provide regulatory benefits, including development incentives and possible market exclusivity.

Zai Lab Limited (ZLAB) Gains EMA Orphan Drug Designation for DLL3-Targeting Cancer Therapy

Earlier on June 8, Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin for injection) for adults with recurrent or metastatic cervical cancer following disease progression after chemotherapy. The approval was supported by results from the global Phase 3 innovaTV 301 trial, which demonstrated an overall survival benefit compared with chemotherapy. Data from the Chinese patient subgroup showed consistent clinical benefit, including a 45% reduction in the risk of death compared with chemotherapy. No new safety concerns were identified, supporting TIVDAK’s potential use in China.

Zai Lab Limited is a global biopharmaceutical company developing and commercializing innovative therapies in oncology, immunology, neuroscience, and infectious diseases across major global markets.

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