Henlius' POHERDY® receives FDA approval for breast cancer treatments

Shanghai Henlius Biotech, Inc. announced today that the United States Food and Drug Administration (FDA) has approved its biologics license application for POHERDY® (pertuzumab-dpzb) 420mg/14mL injection. POHERDY® is indicated for use in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer, as well as neoadjuvant and adjuvant treatment for HER2-positive early breast cancer. This approval follows a comprehensive review of comparative study data demonstrating HLX11’s analytical similarity and clinical comparability to the reference product, Perjeta®.

The FDA’s approval is a significant achievement for Henlius, bringing its total number of products approved for marketing overseas to seven, including four in the United States. Henlius expects to collaborate with its partner, Organon LLC, which holds an exclusive license to commercialize HLX11 globally (excluding mainland China, Hong Kong, Macau, and Taiwan regions), to initiate local commercial sales.

HLX11 is a pertuzumab biosimilar developed independently by Henlius. According to IQVIA MIDAS™ data, the global sales value of pertuzumab products for 2024 was approximately $3.304 bn. Other regulatory submissions for HLX11 include an NDA in China accepted in December 2024, an MAA in Europe accepted in March 2025, and an NDS in Canada accepted in May 2025.