Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received FDA approval for its self-developed injection POHERDY®1, indicating a significant advancement in the treatment of HER2-positive metastatic breast cancer [1]. Group 1: FDA Approval Details - The FDA approved the biologics license application (BLA) for POHERDY®1, which is an injection for intravenous use [1]. - The approved indications include treatment for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [1]. - The drug is also approved for use in combination with trastuzumab and chemotherapy for early-stage breast cancer as part of a comprehensive treatment plan [1]. Group 2: Treatment Applications - POHERDY®1 is indicated for neoadjuvant treatment in adult patients with HER2-positive locally advanced, inflammatory, or early breast cancer [1]. - It is also approved for adjuvant treatment in adult patients with HER2-positive early breast cancer who are at high risk of recurrence [1].