江苏艾迪药业集团股份有限公司 关于公司抗HIV领域两款创新药续约进入国家医保目录的自愿性披露公告

Core Viewpoint - Jiangsu Aidi Pharmaceutical Group Co., Ltd. has successfully renewed the inclusion of two innovative HIV drugs, Ainovelin Tablets and Ainomir Tablets, in the National Medical Insurance Directory for 2025, reflecting the recognition of their clinical value and innovation by the National Healthcare Security Administration [1][5]. Drug Information - Ainovelin Tablets: - Drug Name: Ainovelin Tablets - Medical Insurance Payment Standard: 24.15 yuan per tablet - Composition: Ainovelin 0.15g, Lamivudine 0.3g, Tenofovir Disoproxil Fumarate 0.3g - Registration Category: Class 1 chemical drug - Drug Classification: Antiviral drug for HIV infection - Insurance Category: Category B - Dosage Form: Tablet - Exclusive Variety: Yes - Limited Payment Scope: For HIV infection only - Agreement Validity: January 1, 2026, to December 31, 2027 [1][5]. - Ainomir Tablets: - Drug Name: Ainomir Tablets - Registration Category: Class 1 chemical drug - Drug Classification: Antiviral drug for HIV infection - Insurance Category: Category B - Dosage Form: Tablet - Exclusive Variety: Yes - Limited Payment Scope: For HIV infection only - Agreement Validity: January 1, 2026, to December 31, 2027 [1][3]. Clinical Efficacy - Ainovelin Tablets: - A novel non-nucleoside reverse transcriptase inhibitor (NNRTI) approved in June 2021 for treatment of HIV-1 infection in treatment-naive patients. Phase III clinical trials showed comparable antiviral efficacy to the control drug Efavirenz, with significantly reduced central nervous system side effects and low rates of liver toxicity and rash [2]. - Ainomir Tablets: - A compound formulation that includes two nucleoside reverse transcriptase inhibitors (NRTIs) added to Ainovelin. Approved for domestic sale in December 2022, it has shown sustained viral suppression and comparable safety to imported drugs in head-to-head Phase III trials. The drug has demonstrated advantages in cardiovascular metabolic safety indicators [3][4]. Impact on the Company - The renewal of the two innovative HIV drugs in the National Medical Insurance Directory is expected to enhance their sales and market promotion, significantly benefiting the company's operational development. The company aims to establish a marketing system for domestic HIV innovative drugs and provide diverse treatment options for patients, addressing the urgent need for upgraded HIV treatment in China [5].