China’s National Medical Products Administration (NMPA) has conditionally approved Zymeworks’ zanidatamab for treating individuals with prior treated, unresectable or metastatic human epidermal growth factor receptor 2-positive (HER2+) biliary tract cancer (BTC).
This marks a milestone as zanidatamab is the first dual HER2-targeted bispecific antibody authorised for this indication in the country, specifically for those with high HER2 expression (IHC3+).
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The approval by the NMPA is a result of Zymeworks’ collaboration with BeOne Medicines (previously known as BeiGene), which secured this approval under the terms of their Asia Pacific licence and partnership agreement.
The continuation of this approval is contingent upon the clinical benefit verification in the patients, which is expected to be demonstrated through the current confirmatory trials.
As part of the agreement with BeOne, Zymeworks has already obtained $61m (C$83.48m) in upfront and milestone payments, along with joint development funding for clinical trials of the therapy.
With the NMPA’s approval, Zymeworks is set to obtain a milestone payment of an additional $20m and may earn up to $144m in further development and commercial milestones.
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By GlobalDataMoreover, the company is entitled to tiered royalties on net sales, which could reach up to 19.5% in BeOne’s territories.
Zymeworks CEO and chair 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.”
The therapy secured approval from the US Food and Drug Administration (FDA) last November for the same indication.
This April, Jazz Pharmaceuticals, Zymeworks’ partner, secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the approval of the therapy to treat advanced HER2-positive BTC.
