海南双成药业股份有限公司 关于注射用硼替佐米ANDA获得美国FDA上市许可的公告

Core Viewpoint - The company has received approval from the U.S. FDA for its injectable bortezomib abbreviated new drug application (ANDA), indicating that the product is bioequivalent and therapeutically equivalent to the original drug, which enhances the company's international market presence and product pipeline [1][4]. Drug Basic Information - Drug Name: Injectable Bortezomib - Dosage Form: Injection - Specification: 3.5 mg - Approved Indications: - Treatment of multiple myeloma patients who have not received prior treatment and are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1]. - Part of a combination therapy for multiple myeloma patients under 65 years old who have not received prior treatment, used for high-dose chemotherapy with autologous stem cell rescue following induction therapy [1]. - Treatment of multiple myeloma patients who have received at least one prior treatment and whose disease has progressed [2]. - Treatment of adult patients with mantle cell lymphoma who have not received prior treatment, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [2]. Other Drug-Related Information - In April 2024, the product received a drug registration certificate from the National Medical Products Administration of China, indicating it passed the consistency evaluation [3]. - In October 2025, the product obtained marketing authorization from the Australian Therapeutic Goods Administration (TGA) [3]. Impact on the Company - The approval of the injectable bortezomib ANDA by the U.S. FDA signifies that the company's research and production meet original drug standards, showcasing its international research and production capabilities [4]. - This approval enriches the company's international sales product pipeline and advances its internationalization strategy, positively impacting the company's product influence and future operating performance [4]. - The approval grants the drug legal sales rights in the U.S., enhancing the company's market competitiveness and providing a new profit growth point for sustainable development [4].