JAZZ PHARMACEUTICALS IRELAND LIMITED

Zymeworks Receives FDA Clearance for ZW251, Novel Glypican-3 Targeted ADC for Hepatocellular Carcinoma

- The FDA has cleared Zymeworks' investigational new drug application for ZW251, a first-in-class antibody-drug conjugate targeting glypican-3 for hepatocellular carcinoma treatment. - ZW251 incorporates Zymeworks' proprietary topoisomerase 1 inhibitor payload and demonstrated strong anti-tumor activity in preclinical studies with favorable tolerability up to 120 mg/kg in non-human primates. - The Phase 1 clinical trial is expected to begin in 2025, marking the second ADC from Zymeworks' pipeline to advance to clinical development using their proprietary payload technology. - Glypican-3 is expressed in over 75% of hepatocellular carcinoma cases, representing a significant target for this most common form of primary liver cancer.