On February 8, Fuhong Hanlin (02696) announced that the company's independently developed Pertuzumab biosimilar HLX11's Biologics License Application (BLA) has been accepted by the U.S. Food and Drug Administration (FDA). The application involves indications including combination with trastuzumab and docetaxel for the treatment of HER2-positive metastatic breast cancer patients who have not received anti-HER2 treatment or chemotherapy for metastatic disease, and as part of the overall treatment of early breast cancer for neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early breast cancer patients.

HLX11 is a biosimilar independently developed by the company, intended for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer, treatment of HER2-positive metastatic breast cancer, etc. According to the industry guidelines issued by the FDA, the BLA submitted this time is based on the data generated by HLX11 compared with Perjeta®, including similarity studies and phase III clinical comparison studies. According to data provided by IQVIA, the global sales of Pertuzumab Injection products in 2023 are approximately US$3.622 billion. The company reminds shareholders and potential investors to act cautiously when buying and selling the company's shares.

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