海南双成药业股份有限公司 关于注射用硼替佐米获得澳大利亚药物管理局（TGA）上市许可的公告

Core Points - The company has received marketing authorization for injectable bortezomib from the Australian Therapeutic Goods Administration (TGA) [1][4] - The product is indicated for multiple myeloma and mantle cell lymphoma treatment in specific patient populations [2][3] Drug Information - Product Name: Injectable Bortezomib - Dosage Form: Injection - Specification: 3.5 mg - Approved Indications: - Treatment of previously untreated multiple myeloma patients who are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1] - Part of combination therapy for previously untreated multiple myeloma patients under 65 years old, for high-dose chemotherapy with autologous stem cell rescue [1] - Treatment for multiple myeloma patients who have received at least one prior therapy and have disease progression [2] - Treatment for adult patients with previously untreated mantle cell lymphoma in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [2] Impact on the Company - The approval signifies the product's eligibility for sale in Australia, positively impacting the company's overseas market expansion and performance [4] - The export business may face uncertainties due to market demand fluctuations, policy changes, exchange rate volatility, and market competition [4]