Canadian biotechnology firm Zymeworks announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for zanidatamab.
The approval is for the treatment of patients with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC).
Zanidatamab is the first dual HER2-targeted bispecific antibody approved for HER2-high expression (IHC3+) BTC in China.
The approval was secured by BeOne Medicines, Zymeworks’ collaboration partner, under their Asia Pacific license and collaboration agreement. Continued approval depends on the verification of clinical benefits through ongoing confirmatory trials.
Zymeworks chairperson and CEO Kenneth Galbraith said: “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.
“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.”
As part of its agreement with BeOne Medicines, Zymeworks has received $61m in upfront and milestone payments, alongside co-development funding for zanidatamab clinical studies. The NMPA approval entitles Zymeworks to a $20m milestone payment.
Additionally, the company could receive up to $144m in further development and commercial milestones, along with tiered royalties of up to 19.5% of net sales in BeOne Medicine’s territories.
Previously, the US Food and Drug Administration (FDA) approved zanidatamab in November 2024 for treating adults with previously treated, unresectable, or metastatic HER2+ (IHC 3+) BTC.
In April 2025, Zymeworks’ partner, Jazz Pharmaceuticals, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending the approval of zanidatamab for advanced HER2+ BTC treatment.
