NMPA Approves Zanidatamab in China for Adults with Previously Treated, Unresectable or Metastatic HER2-high expression (IHC3+) Biliary Tract Cancer
“Zanidatamab’s conditional approval in China is a meaningful advancement for patients living with HER2-positive BTC, a population with historically high unmet need and poor prognoses,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “This milestone affirms the strength of zanidatamab’s clinical potential and reflects our continued focus on translating innovation into real impact for patients around the globe. We are deeply grateful to our partners at BeOne Medicines, and to the patients, families, and clinical teams whose contributions have made this milestone a reality. As Zymeworks continues to advance our broader development programs and R&D pipeline, we remain committed to realizing zanidatamab’s potential to transform the standard of care across HER2-expressing cancers.”
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