Fosun Pharma subsidiary Henlix gets clinical trial nod for oncology drug

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Henlius Biotech, Inc. (Henlix), received approval from China's National Medical Products Administration. This approval allows Henlix to conduct clinical trials for HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) in combination with HLX87 (HER2 antibody-drug conjugate) for HER2-positive breast cancer. The trials will investigate the therapy for first-line and neoadjuvant treatment of HER2-positive breast cancer (both Phase II/III).

As of October 2025, the group's cumulative research and development investment for this specific treatment regimen totaled approximately RMB 460,000 (unaudited, excluding single-drug R&D). There are currently no other approved combination therapies with similar indications available globally as of December 9, 2025.

HLX22, a novel anti-HER2 monoclonal antibody, has several ongoing global clinical studies and was granted orphan drug designation by the U.S. FDA and the European Commission in March and May 2025, respectively, for gastric cancer. HLX87, an innovative anti-HER2 antibody-drug conjugate (ADC), is currently in Phase III clinical trials in China for the second-line treatment of HER2-positive breast cancer.