Xin Lang Cai Jing·2025-12-18 08:27Core Viewpoint - The company *ST Shuangcheng has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for injectable bortezomib, indicating that the product is bioequivalent and therapeutically equivalent to the reference drug [1] Group 1: FDA Approval - The U.S. FDA has completed a comprehensive technical review of the ANDA submitted by the company [1] - The approval confirms that the company's product is equivalent in terms of biological and therapeutic effects to the original drug [1] Group 2: Approved Indications - The approved indications for the injectable bortezomib include: 1. Treatment of previously untreated multiple myeloma patients who are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1] 2. Part of a combination therapy for previously untreated multiple myeloma patients under 65 years old, used for high-dose chemotherapy with autologous stem cell rescue following prior induction therapy [1] 3. Treatment for multiple myeloma patients who have received at least one prior therapy and whose disease has progressed [1] 4. Treatment of adult patients with previously untreated mantle cell lymphoma in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [1]