HIV整合酶抑制剂
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江苏艾迪药业集团股份有限公司 关于ACC017片III期临床试验首例受试者成功入组的自愿性披露公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-11-08 00:19
Core Viewpoint - The company is advancing its self-developed HIV drug ACC017, which is currently undergoing a Phase III clinical trial to evaluate its efficacy and safety in treatment-naive adults with HIV-1, with the first participant enrolled on November 7, 2025 [1][3]. Drug Overview - ACC017 is a novel integrase strand transfer inhibitor (INSTI) with a unique chemical structure, aimed at blocking the integration of the HIV genome into the host DNA, and is intended for the treatment of HIV infection [1][2]. - The global sales of HIV integrase inhibitors are projected to reach nearly $25 billion in 2024, with products containing Bictegravir (BIC) and Dolutegravir (DTG) accounting for approximately $21 billion [1]. Research and Development Progress - The company received approval from the National Medical Products Administration for the clinical trial of ACC017 on January 5, 2024 [2]. - A Phase I clinical study was completed in August 2024, showing good safety profiles and effective absorption for once-daily dosing [2]. - A Phase I/II study for treatment-naive HIV patients was completed in July 2025, confirming good safety and efficacy when combined with FTC/TAF [2]. Impact on the Company - If approved, ACC017 is expected to provide a differentiated advantage in clinical treatment, offering a domestic innovative alternative to imported drugs, thereby expanding the company's HIV product line and diversifying its revenue sources [3]. - The successful enrollment of the first participant in the Phase III trial is not expected to have a significant impact on the company's recent performance [3].