Zymeworks Inc. has recently announced the National Medical Products Administration (NMPA) approval of Zanidatamab in China for the treatment of previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC). This marks a significant development as Zanidatamab becomes the first and only dual HER2-targeted bispecific antibody approved for HER2-high expression BTC in China. The conditional approval is based on the results of the HERIZON-BTC-01 clinical study.
Under the terms of the agreement with Beone Medicines Ltd., Zymeworks has received $61 million in upfront and milestone payments, including a $20 million milestone payment in connection with the NMPA approval of Zanidatamab. Additionally, Zymeworks remains eligible to receive up to $144 million in additional development and commercial milestones, as well as tiered royalties of up to 19.5% of net sales in Beone Medicine's territories.
Zanidatamab was previously approved by the U.S. Food and Drug Administration (FDA) in November 2024 and had a positive opinion recommending approval by the European Medicines Agency (EMA) committee for the treatment of advanced HER2+ BTC in April 2025.
Biliary tract cancers, which include gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, account for approximately 3% of all digestive system tumors and are often associated with a poor prognosis. The incidence rate of BTC is on the rise globally, particularly in Asian countries and regions.
Zanidatamab is a dual HER2-targeted bispecific antibody that induces complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and antibody-dependent cellular phagocytosis, resulting in tumor growth inhibition and tumor cell death.
Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics, with a focus on making a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The company's mission is supported by its proprietary azymetric™ technology, which was used to engineer and develop Zanidatamab.
In addition to Zanidatamab, Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, including ZW171 and ZW191, with phase 1 studies actively recruiting and an investigational new drug application for ZW251 planned for mid-2025. The company's therapeutic platforms have also been leveraged through strategic partnerships with global biopharmaceutical companies.
Today the company's shares have moved 0.7% to a price of $11.43. Check out the company's full 8-K submission here.
