Zymeworks(ZYME) Globenewswire·2025-05-30 10:00Core Insights - Zymeworks Inc. announced the conditional approval of zanidatamab by the National Medical Products Administration (NMPA) in China for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC), marking it as the first dual HER2-targeted bispecific antibody approved for this indication in China [1][10] - The approval is a significant advancement for patients with HER2-positive BTC, a group with high unmet medical needs and poor prognoses, and reflects the clinical potential of zanidatamab [2][4] - Zymeworks has received 20 million milestone payment linked to the NMPA approval and potential for up to $144 million in further milestones [2][6] Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing multifunctional biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][6] - The company utilizes its proprietary Azymetric™ technology to engineer and develop zanidatamab, which targets HER2 and induces various mechanisms leading to tumor growth inhibition [5][7] - Zymeworks has strategic partnerships with BeOne Medicines and Jazz Pharmaceuticals, granting exclusive rights for the development and commercialization of zanidatamab in different territories [7] Industry Context - Biliary tract cancers account for approximately 3% of all digestive system tumors, with a rising incidence rate globally, particularly in Asia [4] - Approximately 11%-25.2% of patients with BTC are HER2-positive, making HER2 a validated target for antitumor therapy [4] - Zanidatamab has also received FDA approval in the U.S. and is under regulatory review in the EU, indicating its potential as a best-in-class treatment for HER2-expressing cancers [3][7]