Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received marketing approval from Australia’s Therapeutic Goods Administration (TGA) for its Hanquyou (trastuzumab injection, EU trade name: Zercepac). The drug will be marketed under the trade names Tuzucip and Trastucip to treat HER2-positive early breast cancer, HER2-positive locally advanced breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-positive advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. The approval covers all indications approved for the originator product.
Drug Profile
Hanquyou was approved in China in July 2020 and in the European Union in August 2020. The drug has since entered multiple global markets. In 2018, India-based Cipla signed a licensing deal with Henlius, securing exclusive development and commercialization rights to Hanquyou in Australia and other markets.-Fineline Info & Tech
