Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed injectable drug POHERDY®1 (HLX11), 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 injectable solution 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 therapy or chemotherapy [1] - The drug is also indicated 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]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed injectable drug POHERDY®1, indicating a significant advancement in the treatment of HER2-positive metastatic breast cancer and early-stage breast cancer [1] Group 1: FDA Approval Details - The FDA approved the biologics license application (BLA) for POHERDY®1, which is an injectable solution 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 patients, specifically for those with locally advanced, inflammatory, or early-stage breast cancer [1] Group 2: Treatment Combinations - POHERDY®1 is indicated for use in conjunction with trastuzumab and docetaxel for treating metastatic breast cancer [1] - It is also part of a comprehensive treatment regimen for early-stage breast cancer patients with high recurrence risk [1] - The drug serves as neoadjuvant therapy for adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer [1]