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Zymeworks and Jazz Pharmaceuticals’ Ziihera Gets Green Light for HER2+ BTC Treatment
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Partners Zymeworks Inc. (NASDAQ: ZYME) and Jazz Pharmaceuticals, Inc. have received accelerated approval from the US Food and Drug Administration (FDA) for Ziihera (zanidatamab), a treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). This marks a significant advancement in the treatment options for…
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Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
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Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed…
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Zymeworks and BeiGene Terminate Licensing Agreement for ZW49 ADC
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Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report that the licensing agreement with China’s BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) for the antibody drug conjugate (ADC) zanidatamab zovodotin (ZW49) has been cancelled. This development affects the HER2-targeted ADC that BeiGene had…
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BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
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The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
