Zhitong Finance App, Fuhong Hanlin-B (02696) issued an announcement. Recently, HLX02 (injectable trastuzumab, EU trade name: Zercepac®) submitted by Accord Healthcare S.L.U. (a wholly-owned subsidiary of the company's business partner Accord Healthcare Limited) for treatment of HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer, and untreated HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma The Marketing Authorization Application (MAA) was approved by the European Commission (EC).

Following this approval, HLX02 has obtained a centralized listing license in all EU member states as well as Iceland, Liechtenstein, and Norway (each in the European Economic Area (EEA)).

HLX02 is a monobiotic analogue independently developed by the company in accordance with the guidelines for biosimilar drugs in China and the European Union. It is used in the treatment of indications for HER2 positive early-stage breast cancer, HER2 positive metastatic breast cancer, and untreated HER2 positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma. In April 2019, HLX02's New Drug Marketing Application (NDA) was accepted by the State Drug Administration and subsequently included in the priority review and approval process.