Aidi Pharmaceuticals' ACC085 Injection Approved for Clinical Trials! Expected to fill the gap in the domestic long-acting pre-exposure prophylaxis for HIV field

（Source: Aidi Pharmaceutical）

From treatment to prevention, Jiangsu Aidi Pharmaceutical Group has achieved another milestone in the field of combating HIV/AIDS. On April 6, Aidi Pharmaceutical (688488.SH) released an announcement, stating that its self-developed Type 1 new anti-HIV drug, ACC085 injection, has officially obtained approval for a clinical trial application. It is planned for pre-exposure prophylaxis (PrEP) in adults with a risk of HIV-1 infection and adolescents weighing at least 35 kg. This is the first self-developed, long-acting HIV capsid inhibitor-type PrEP drug in China to enter the clinical trial stage, and it also marks a key step in the company’s strategic shift in the field of HIV prevention and control—from treatment to prevention.

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A brand-new mechanism Blocking multiple stages of HIV replication

ACC085 is a new HIV-1 capsid functional inhibitor developed independently by Aidi Pharmaceutical, with a novel chemical structure. It belongs to Type 1 new chemical drugs. Unlike traditional anti-HIV/AIDS medicines, ACC085 can bind directly to the interface between capsid protein subunits. By interfering with multiple key steps in the viral life cycle, it suppresses HIV-1 replication:

· Blocks capsid-mediated HIV-1 proviral DNA nuclear entry

· Inhibits viral assembly and release

· Disrupts the capsid nucleation process

This multi-stage mechanism of action gives ACC085 outstanding antiviral activity. Preclinical studies show that ACC085 demonstrates good antiviral activity against multiple HIV-1 laboratory strains, clinical isolates, and various drug-resistant strains. In animal models of HIV-1 infection, it has demonstrated promising preventive and protective effects. Particularly noteworthy are its excellent pharmacokinetic properties, which suggest that ACC085 has significant potential for long-acting use. It is expected to greatly reduce dosing frequency and significantly improve patients’ medication adherence.

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Urgent need Long-acting PrEP is key to prevention and control

According to a report released by the United Nations AIDS Programme in July 2025, there are currently 40.8 million people living with HIV worldwide. In 2024, there were 1.3 million new HIV infections globally, and 630k people died from HIV/AIDS-related diseases. The global HIV infection situation remains severe.

In China, sexual transmission has become the primary route of HIV transmission. Pre-exposure prophylaxis (PrEP) for AIDS exposure is one of the key biomedical strategies to control HIV transmission. By having people who are not infected but are continuously exposed to high-risk environments start using antiviral drugs in advance, a protective barrier can be established before viral exposure, effectively blocking HIV infection. This strategy has been listed in the “China AIDS Diagnosis and Treatment Guidelines (2024 Edition)” as an important intervention measure for high-risk populations, and it is highly aligned with the overall guideline of the “China Plan for Controlling and Preventing AIDS (2024–2030)”—“prevention first, combining prevention and treatment.”

In June 2025, the U.S. FDA formally approved lenkapavir for pre-exposure prophylaxis in adults and adolescents weighing ≥35 kg, and the clinical value of long-acting PrEP drugs has been widely recognized internationally. However, there are currently no approved long-acting PrEP drugs developed independently in China, and clinical demand remains far from being met.

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Deepening efforts against HIV/AIDS Build a full-chain prevention and control system

Since its establishment, Aidi Pharmaceutical has consistently treated innovative R&D of anti-HIV/AIDS drugs as a core strategic direction. Focusing on unmet clinical needs, the company has successfully launched two National Type 1 new drugs, enomitrivir and enavirline 2, as well as multiple anti-HIV/AIDS treatment drugs such as dolutegravir sodium tablets, forming a complete treatment product line covering both treatment-naïve patients and patients who have been treated.

The approval of ACC085 injection for a clinical trial is an important breakthrough for Aidi Pharmaceutical’s innovation product pipeline extending from “treatment” to “prevention.” It will further improve the company’s full-chain layout in the field of HIV prevention and control. As the first self-developed long-acting PrEP candidate drug in China to enter the clinical trial stage, ACC085 injection is expected to fill the gap in this area domestically. It will provide high-risk groups in China with a more convenient, effective, and accessible new prevention option, inject new momentum into China’s HIV prevention and control efforts, and demonstrate significant public health value.

In the future, the company will accelerate the progress of clinical trials for this drug, aiming to bring this domestically innovative achievement to the market as early as possible, benefit a broad range of people with needs, and contribute Aidi’s strength to end the HIV/AIDS epidemic and strengthen public health defenses.

Statement:

This material is intended to convey disease-related knowledge and cutting-edge information in the pharmaceutical field. It is not for advertising purposes and is for reference only by medical and healthcare professionals. It does not constitute a recommendation of any drug’s commercial promotion or a recommendation of any diagnosis and treatment plan. Our company does not recommend any drugs and/or indications. If you wish to learn specific disease diagnosis and treatment information, please follow the opinions or guidance of medical and healthcare professionals.

Forward-looking statement:

This press release contains certain forward-looking statements, including statements about the clinical development plans of 【ACC085, enomitrivir, enavirline 2】, the anticipated expectations of clinical benefits and advantages, commercialization outlook, the potential likelihood of patients’ clinical benefits, as well as potential commercial opportunities. Terms such as “expected,” “believe,” “continue,” “may,” “estimate,” “hope,” “promising,” “intend,” “plan,” “potential,” “forecast,” “anticipate,” “should,” “will,” “proposed,” “would,” and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words.

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