Fosun Pharma subsidiary gains US FDA approval for breast cancer drug POHERDY

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its controlled subsidiary, Shanghai Henlius Biotech, Inc., received U.S. FDA approval for POHERDY® (pertuzumab, project code: HLX11). This biological product, an advanced pertuzumab biosimilar, is approved for treating HER2-positive metastatic breast cancer and for neo-adjuvant and adjuvant treatment of early breast cancer. This marks the fourth product from Henlius Biotech to be approved in the U.S., strengthening the group's international market presence.

HLX11's commercialization rights outside of China, Hong Kong, Macau, and Taiwan, including the U.S. market, were granted to Organon LLC in June 2022. Following the U.S. approval of POHERDY®, Henlius Biotech will be entitled to sales milestones and royalties as per the licensing agreement. The total R&D investment for HLX11 by the group as of October 2025 is approximately RMB 225m.

In addition to the U.S. approval, HLX11's registration process is advancing globally. The marketing authorization application for HLX11 was accepted by China’s National Medical Products Administration in December 2024, by the European Medicines Agency in March 2025, and by Health Canada in May 2025. According to IQVIA MIDAS™ data, global sales of pertuzumab products in 2024 were approximately $3.304bn.