Zymeworks’ Drug Gets Conditional Approval For Biliary Tract Cancer Treatment In China: Retail Sentiment Refuses To Budge

Shares of Zymeworks Inc. (ZYME) were in the spotlight on Friday morning after the company announced that the National Medical Products Administration (NMPA) in China approved Zanidatamab, a bispecific antibody it developed, for the treatment of patients with a type of biliary tract cancer (BTC).

The approval is for the treatment of patients with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer, a diverse group of cancers that affect the bile ducts and gallbladder.

Zymeworks’ collaboration partner, BeOne Medicines (formerly BeiGene), obtained conditional approval under the terms of its license and collaboration agreement with Zymeworks in the region.

The continued approval of the therapy for BTC will depend on confirmation of clinical benefit through ongoing confirmatory trials, the company said.

The U.S. Food and Drug Administration (FDA) approved the therapy for BTC in November.  

The incidence rate of BTC is on the rise globally, particularly in Asia, the company said, while also noting that BTC accounts for approximately 3% of all digestive system tumors.

Zymeworks is entitled to receive a $20 million milestone payment in connection with the NMPA approval of Zanidatamab as part of its agreement with BeOne Medicines.

The company is also 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.

On Stocktwits, retail sentiment around ZYME stayed unmoved within the ‘bearish’ territory over the past 24 hours while message volume dipped from ‘normal’ to ‘low’ levels.

ZYME stock is down by 23% this year but up by about 35% over the past 12 months.

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