荣昌生物(688331.SH):维迪西妥单抗用于治疗HER2低表达且存在肝转移的乳腺癌适应症上市申请获得批准
Core Viewpoint - Rongchang Biopharmaceutical (688331.SH) has received approval from the National Medical Products Administration for the new indication of Vidixtimab (RC48, brand name: Aidiqi®) for the treatment of HER2 low-expressing breast cancer with liver metastasis, marking the fourth approved indication for this drug in China [1] Group 1 - The new indication is specifically for adult breast cancer patients who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy, and who have unresectable or metastatic HER2 low-expressing (IHC1+ or IHC2+/ISH-) breast cancer with liver metastasis [1]