Aidi Pharmaceuticals' Investigational New Drug for Anti-AIDS Therapy Approved for Clinical Trials

证券时报记者 李映泉

On the evening of April 6, Aidi Pharmaceuticals (688488) released an announcement stating that the company and its wholly owned subsidiary, Luzhou Aidi Pharmaceutical Technology Co., Ltd., received a Notice of Approval for a drug clinical trial issued by the National Medical Products Administration. The notice approves the company’s in-development Category 1 new drug, ACC085 injection, in the field of anti-HIV, to proceed with clinical trials.

The announcement states that ACC085 is a new chemical-structure HIV-1 capsid functional inhibitor independently developed by Aidi Pharmaceuticals. It is a Category 1 new chemical drug. It can directly bind to the interface between capsid protein subunits, thereby suppressing HIV-1 replication by interfering with multiple key steps in the virus life cycle, including nuclear import of HIV-1 pre-vial DNA mediated by the capsid, viral assembly and release, and capsid-nucleus formation.

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

According to the latest report from 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 globally; and 630k people died from AIDS-related illnesses. In June 2025, the U.S. Food and Drug Administration (FDA) officially approved a new indication for Lenacapavir: for pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg.

In China, as an effective measure to reduce new HIV infections among people at high risk, pre-exposure prophylaxis is listed in the “China HIV/AIDS Diagnosis and Treatment Guidelines (2024 Edition)” as one of the important intervention strategies for high-risk groups. The “China AIDS Prevention, Control, and Treatment Plan (2024–2030)” also clearly sets out the overall principle of “prevention first, and prevention and treatment combined.”

And the indication of ACC085 is precisely for pre-exposure prophylaxis in adults and adolescents at risk of HIV-1 infection, with a body weight of at least 35 kg.

Previously, Aidi Pharmaceuticals disclosed that its 2025 annual report shows the company achieved operating revenue of RMB 719 million in 2025, an increase of 72.13% year over year; net profit attributable to shareholders of listed companies was -RMB 19.5323 million, narrowing the loss by approximately 86.17% year over year; and basic earnings per share were -RMB 0.05.

After the annual report was disclosed, Aidi Pharmaceuticals immediately organized an institutional investor research and survey activity. In its research, the company stated that in 2025, its two major R&D pipelines in the anti-HIV and human protein sectors both made phased progress. In the anti-HIV field, the company’s new-generation integrase inhibitor, the ACC017 Phase III clinical trial, was officially launched and is being advanced in an orderly manner; relevant core patents have been granted in Japan; and the combination product ADC118 was approved for clinical trials. The application for a clinical trial for the long-acting pre-exposure prophylaxis drug ACC085 injection has been accepted; ACC077 tablets are in the preclinical development stage, and the relevant core molecules have completed PCT patent applications.

Specifically, ACC085 injection and ACC077 tablets are two long-acting innovative products that Aidi Pharmaceuticals has laid out, focusing on the long-acting prevention area.

Among them, ACC085 injection, as a novel capsid protein inhibitor independently developed by Aidi Pharmaceuticals, focuses its clinical development on the major public-health need area of HIV pre-exposure prophylaxis (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 people at high risk.

ACC077 tablets, as an orally administered long-acting formulation independently developed by Aidi Pharmaceuticals, likewise focuses its clinical development on the long-acting prevention area for HIV. It has already completed initial pharmaceutical research and drug-likeness evaluation. Initial results indicate good drug-likeness, and it is expected to provide a more adherence-friendly oral prevention option for high-risk populations. The company has completed the global patent landscape for the product’s core molecule, and it is also actively advancing related early exploration work.

It is said that the two long-acting products above are expected to form a “prevention-treatment” synergistic ecosystem with the company’s existing anti-HIV treatment pipeline, further improving the company’s end-to-end industry chain layout in the HIV field.