Aidi Pharmaceuticals: Anti-AIDS investigational new drug ACC085 approved for clinical trials

On the evening of April 6, Edi Pharmaceutical (688488) announced that the company and its wholly owned subsidiary, Luzhou Edi Pharmaceutical Technology Co., Ltd., have recently received a Drug Clinical Trial Approval Notice that was examined and approved by the National Medical Products Administration, according to the announcement. The notice agrees that the company’s investigational Class 1 new drug ACC085 injection in the anti-HIV area will carry out clinical trials.

The indication targets HIV pre-exposure prevention

The announcement introduced that ACC085 is a newly developed chemical-structure drug that Edi Pharmaceutical independently researched. It is a Class 1 new chemical drug and an HIV-1 capsid functional inhibitor. It can directly bind to the interface between capsid protein subunits, and thereby inhibit HIV-1 replication by interfering with multiple key steps in the virus life cycle (including the capsid-mediated nuclear uptake of HIV-1 pre-viral DNA, viral assembly and release, and capsid core formation).

Preclinical studies show that ACC085 has strong antiviral activity against various HIV-1 laboratory strains, clinical isolates, and multiple drug-resistant strains. It also has good preventive protective effects in animal models of HIV-1 infection, and its pharmacokinetic characteristics suggest long-acting potential.

According to the latest report released by the Joint United Nations Programme on HIV/AIDS (UNAIDS) in July 2025, there are 40.8 million people living with HIV worldwide. In 2024, there were 1.3 million new HIV infections worldwide, and 630,000 people died from AIDS-related diseases. This shows that the global HIV infection situation remains severe, and strengthening prevention and control is an urgent priority.

In June 2025, the U.S. Food and Drug Administration (FDA) officially approved a new indication for Lenacapavir: for pre-exposure prevention in adults and adolescents weighing ≥35 kg. Lenacapavir has already been recommended by the World Health Organization (WHO) as one of the methods for HIV pre-exposure prevention.

In China, as an effective approach to reduce new HIV infections among high-risk populations, pre-exposure prevention is listed in the “China Guidelines for the Diagnosis and Treatment of AIDS (2024 Edition)” as one of the important intervention strategies for high-risk groups. The “Action Plan for Containment and Prevention of AIDS in China (2024–2030)” also clearly sets out the overall policy of “prevention first, with treatment in combination.”

Meanwhile, ACC085’s indication is precisely for pre-exposure prevention (PrEP) in adults and adolescents who have a risk of HIV-1 infection, with a body weight of at least 35 kg.

Two long-acting innovative HIV products have been developed

Edi Pharmaceutical is a national high-tech enterprise focusing on anti-HIV drugs and human protein fields. Previously, Edi Pharmaceutical disclosed that its 2025 annual report shows that in 2025, the company achieved operating revenue of 719 million yuan, an increase of 72.13% year over year. The net profit attributable to shareholders of listed companies was -19.53 million yuan, representing a reduction in losses of approximately 86.17% year over year. Basic earnings per share were -0.05 yuan.

After the annual report was disclosed, Edi Pharmaceutical immediately organized an investigation and research activity for institutional investors. In the course of the research, the company stated that in 2025, its R&D pipelines in both major areas—anti-HIV and human proteins—had achieved phased progress. In the anti-HIV field, the company’s new-generation integrase inhibitor ACC017 Phase III clinical trial has been officially initiated and is being advanced in an orderly manner. Relevant core patents have been granted in Japan, and its fixed-dose combination product ADC118 tablets have been approved for clinical trials. The clinical trial application for long-acting pre-exposure prevention drug ACC085 injection has been accepted, and ACC077 tablets are in the preclinical development stage; the related core molecules have completed PCT patent applications.

More specifically, ACC085 injection and ACC077 tablets are the two long-acting innovative HIV products Edi Pharmaceutical has planned and developed, focusing on the long-acting prevention area.

Among them, ACC085 injection, as a novel capsid protein inhibitor independently developed by Edi Pharmaceutical, has clinical development focused on the major public health need area of HIV pre-exposure prevention (PrEP). By blocking viral capsid assembly, it has a unique mechanism of action and is expected to provide a safer and more convenient long-acting prevention option for high-risk populations.

ACC077 tablets, as an orally administered long-acting formulation independently developed by Edi Pharmaceutical, also has clinical development focused on the HIV long-acting prevention area. The company has already completed preliminary pharmaceutical research and druggability assessment, and the preliminary results indicate good druggability. The product is expected to provide a more adherence-friendly oral prevention option for people at high risk. The company has completed the global patent layout for the core molecules of this product, and is also actively advancing related preliminary exploratory work.

“Of the above two long-acting products, they are expected to form a ‘prevention-treatment’ synergistic ecosystem with the company’s existing anti-HIV treatment pipeline, further improving the company’s full-industry-chain layout in the HIV field, and comprehensively helping to enhance China’s overall HIV prevention and control capabilities.”

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