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抗艾滋病药
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江苏艾迪药业集团股份有限公司 关于多替拉韦钠原料药获得上市申请批准通知书的自愿性披露公告
Core Points - The company has received approval from the National Medical Products Administration for the listing application of the chemical raw material drug Dolutegravir Sodium [1][3] - Dolutegravir Sodium is part of the company's fundraising project focused on the R&D of high-end generic drugs for HIV [2][3] - The approval indicates that the raw material meets national drug review technical standards, allowing for its use in domestic formulations [3] Company Information - The production enterprise is Yangzhou Aidi Pharmaceutical Technology Co., Ltd., located at No. 6 Qiqiao Road, Yangzhou High-tech Industrial Development Zone [2] - The raw material is packaged in various specifications: 20kg, 5kg, 1kg, and 0.5kg [1] Impact on the Company - The approval of Dolutegravir Sodium is expected to enhance the supply and quality of raw materials, potentially lowering production costs [3] - If the generic version of Dolutegravir Sodium is approved for market, it will diversify the company's offerings in anti-HIV medications and complement existing products [3] - The company will continue to advance the registration and listing of the formulation following the approval of the raw material [3]