FOSUN PHARMA (600196.SH) announced that its controlling subsidiary, Shanghai Henlius Biotech, Inc., and its controlled subsidiaries (collectively referred to as "Henlius") have received approval from the National Medical Products Administration for the market registration application of their self-developed pertuzumab injection (domestic brand name: Han Bei You®). The approved indications cover all indications for which the original pertuzumab injection has been approved in China, specifically including: 1. Early Breast Cancer: In combination with trastuzumab and chemotherapy for: (1) Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early breast cancer (tumor diameter >2cm or lymph node-positive), as part of a complete early breast cancer treatment regimen; (2) Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. 2. Metastatic Breast Cancer: In combination with trastuzumab and docetaxel, for the treatment of patients with HER2-positive metastatic or unresectable locally recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
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