In a groundbreaking development, China’s National Medical Products Administration (NMPA) has conditionally approved Zymeworks’ zanidatamab for individuals battling unresectable or metastatic human epidermal growth factor receptor 2-positive (HER2+) biliary tract cancer (BTC). This approval is a significant milestone as zanidatamab becomes the first dual HER2-targeted bispecific antibody sanctioned for this particular use in China, particularly for patients with high HER2 expression.
The journey leading to this accomplishment was paved through a strategic collaboration between Zymeworks and BeOne Medicines. The partnership agreement enabled BeOne Medicines to secure approval under their Asia-Pacific license, marking a pivotal moment in the fight against BTC. The ongoing approval hinges on verifying the clinical benefits in patients, an aspect expected to be demonstrated during current confirmatory trials.
Kenneth Galbraith, CEO, and Chair of Zymeworks expressed his enthusiasm regarding the approval stating,
“Zanidatamab’s conditional approval in China is a meaningful advancement for patients living with HER2-positive BTC.”
This achievement underscores the therapy’s immense clinical potential and highlights the companies’ dedication to transforming innovative solutions into tangible benefits for patients worldwide.
As part of their collaboration agreement, Zymeworks has already received substantial upfront payments totaling $61 million (C$83.48 million), including joint funding for further clinical trials. With this recent nod from NMPA, Zymeworks stands to gain an additional $20 million as a milestone payment and could potentially earn up to $144 million through subsequent developmental and commercial milestones.
Moreover, Zymeworks is poised to receive tiered royalties on net sales that may peak at 19.5% within BeOne’s territories. This not only signifies financial gains but also cements the company’s position as a key player in advancing cancer therapies globally.
The global impact of zanidatamab’s approval is bolstered by its prior authorization by US FDA last November for the same indication. Furthermore, Jazz Pharmaceuticals, another partner of Zymeworks, secured a positive opinion from the European Medicines Agency earlier this year—a testament to zanidatamab’s growing recognition in diverse regions around the world.
This monumental step towards enhancing treatment options for HER2+ BTC patients showcases the power of collaborative efforts between pharmaceutical companies like Zymeworks and BeOne Medicines. As research and innovation continue to drive progress in oncology treatments, such breakthrough approvals pave the way for improved patient outcomes and offer hope where it was once scarce.
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