FOSUN PHARMA (600196.SH) announced that its subsidiary, Shanghai Henlius Biotech, Inc., and its controlled subsidiary have obtained U.S. FDA approval for the Biologics License Application (BLA) of their self-developed POHERDY®1 (420mg/14mL (30mg/mL)) injection (for intravenous use) (pertuzumab, project code: HLX11). The approved indications include: (1) Combination therapy with trastuzumab and docetaxel for the treatment of HER2-positive, metastatic breast cancer (MBC) in adult patients who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease; (2) Combination therapy with trastuzumab and chemotherapy as: ① part of a comprehensive treatment plan for early breast cancer in HER2-positive, locally advanced, inflammatory, or early-stage breast cancer patients (tumor diameter >2cm or lymph node-positive) for neoadjuvant treatment; and ② adjuvant treatment for adult patients with HER2-positive early breast cancer at high risk of recurrence.