By Fineline Cube 
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that it has received conditional approval from China’s National Medical Products Administration (NMPA) for Ziihera (zanidatamab), a HER2-targeted bispecific antibody. The drug is indicated for the treatment of unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) in patients who have been previously treated with systemic therapy.
Clinical Trial Results
The regulatory decision is based on results from the pivotal HERIZON-BTC-01 study, which assessed the efficacy and safety of zanidatamab in previously treated, unresectable HER2-amplified advanced or metastatic BTC patients. The results demonstrated significant efficacy and good safety. The Independent Review Committee (IRC) confirmed an objective response rate (ORR) of 51.6%, a median duration of response (mDoR) of 14.9 months, a median progression-free survival (mPFS) of 7.2 months, and a median overall survival (mOS) of 18.1 months.
Development and Commercialization Rights
BeOne Medicines acquired the development and commercialization rights to Zymeworks Inc.’s (NASDAQ: ZYME) Ziihera through a 2018 deal, with an upfront payment of USD 53 million. Jazz Pharmaceuticals, Inc., Zymeworks’ partner, is responsible for the development and commercialization of the drug in the United States, Europe, Japan, and all other regions.-Fineline Info & Tech