Aidi Pharmaceuticals' investigational Class 1 new drug for AIDS approved for clinical trials

On the evening of April 6th, Aidi Pharmaceutical (688488) announced that the company and its wholly-owned subsidiary Luzhou Aidi Pharmaceutical Technology Co., Ltd. received the drug clinical trial approval notice issued by the National Medical Products Administration, approving the company’s ongoing Class 1 new drug ACC085 injection for AIDS in the research and development stage to conduct clinical trials.

The announcement states that ACC085 is a novel chemical structure HIV-1 capsid function inhibitor independently developed by Aidi Pharmaceutical, classified as a chemical drug Class 1 new drug. It can directly bind at the interface between capsid protein subunits, interfering with multiple key steps in the viral life cycle (including capsid-mediated HIV-1 pre-viral DNA nuclear import, virus assembly and release, and capsid core formation), thereby inhibiting HIV-1 replication.

Preclinical studies show that ACC085 has strong antiviral activity against various HIV-1 experimental strains, clinical isolates, and drug-resistant strains. It provides good preventive protection in animal models of HIV-1 infection, and pharmacokinetic characteristics suggest its potential for long-lasting effects.

According to the latest report from UNAIDS in July 2025: there are currently 40.8 million people living with HIV worldwide, with 1.3 million new HIV infections globally in 2024, and 630k deaths related to AIDS. 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 ≥35kg.

Domestically, as an effective measure to reduce new HIV infections among high-risk populations, pre-exposure prophylaxis (PrEP) is listed as one of the key intervention strategies in the “China AIDS Prevention and Control Plan (2024–2030).” The “China AIDS Prevention and Control Plan (2024–2030)” also clearly states the general principle of “prevention first, combined prevention and treatment.”

ACC085’s indication is specifically for pre-exposure prevention in adults and adolescents weighing at least 35kg who are at risk of HIV-1 infection.

Previously, Aidi Pharmaceutical disclosed in its 2025 annual report that the company achieved operating revenue of 719 million yuan in 2025, a 72.13% increase compared to the previous year; net profit attributable to shareholders of the listed company was -19.53 million yuan, a decrease in loss of approximately 86.17%; basic earnings per share were -0.05 yuan.

Following the annual report release, Aidi Pharmaceutical organized investor research activities. During the research, the company stated that in 2025, its R&D pipelines in the two major fields of anti-HIV and human proteins achieved phased progress. In the anti-HIV field, the company’s new generation integrase inhibitor ACC017 completed Phase III clinical trials with orderly progress, and related core patents have been granted in Japan. Its combination drug ADC118 has been approved for clinical trials; the clinical trial application for long-acting pre-exposure prophylaxis drug ACC085 injection has been accepted, and ACC077 tablets are in preclinical development, with core molecules having completed PCT patent applications.

Specifically, ACC085 injection and ACC077 tablets are two long-acting innovative HIV products developed by Aidi Pharmaceutical, focusing on the long-acting prevention field.

Among them, ACC085 injection, as a new capsid protein inhibitor independently developed by Aidi Pharmaceutical, focuses on the major public health need of HIV pre-exposure prophylaxis (PrEP). The drug works by blocking capsid assembly, with 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, an oral long-acting formulation independently developed by Aidi Pharmaceutical, also focuses on HIV long-acting prevention. It has completed preliminary pharmaceutical research and druggability assessments, with initial results showing good druggability, potentially offering a more compliant oral prevention option for high-risk groups. The company has completed global patent layout for the core molecules of this product and is actively advancing related early-stage exploratory work.

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