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UB-421

Product Description

In addition to its potential for achieving functional cure, the monoclonal antibody UB-421 stands out for its remarkable efficacy in treating patients with multidrug-resistant HIV.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) is currently using UB-421 to treat patients with multidrug-resistant HIV, with highly promising results. These findings were recognized and published in the prestigious journal Nature Medicine in January 2025.

UB-421

Pharmacological
Mechanism

AIDS is a disease characterized by an unpredictable latency period, during which the virus opportunistically invades and deactivates the immune system. Most patients ultimately die from complications caused by opportunistic infections. The virus is highly drug-resistant, and current therapies can only suppress viral activation but cannot completely eradicate it. Since 2017, the prevention and treatment of AIDS has been listed as a key priority under China’s 13th Five-Year Plan. Although the situation has improved by 2024, it remains unresolved. According to the latest policies, there is a clear directive to significantly improve the quality of antiviral treatment, with the goal of reducing the overall population infection rate to below 0.2% by 2030.

UB-421

Current Disease
Landscape

Currently, there are approximately 39 million people living with HIV/AIDS worldwide, with about 1.4 million cases in China. However, the number of domestic patients remains poorly controlled, with an annual growth rate of 7%.At present, HIV treatment primarily relies on a combination of two nucleoside reverse transcriptase inhibitors (NRTIs) with another antiretroviral agent of a different mechanism. However, patients are increasingly facing serious challenges, including a lack of long-acting therapies, significant side effects, and limited options due to multidrug resistance.

39million patients

Global population distribution of AIDS
1.4million patients

Population affected domestically
7%

Annual growth rate of patients

Currently, people living with HIV face five major unmet treatment needs:

Heavy burden of daily medication
Widespread systemic side effects
Limited treatment options for multidrug-resistant strains
Lack of long-acting therapeutic agents
No available therapies capable of achieving functional cure

Therefore, both clinicians and patients are urgently seeking an ideal treatment option that is long-acting, convenient to use, and has a high resistance barrier to minimize the risk of future drug resistance.

UB-421

Product Overview

UB-421 not only holds the potential for achieving a functional cure for HIV, but also stands out for its remarkable efficacy in treating patients with multidrug-resistant HIV.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) is currently using UB-421 to treat patients with multidrug-resistant HIV, with highly significant results. These findings were honored with a publication in the internationally renowned journal Nature Medicine in January 2025.

UB-421, a fully human, original monoclonal antibody formulated for intravenous infusion, has completed multiple clinical trials and possesses the following key features:

UB-421

Competes with HIV for the CD4 binding site on immune T cells to protect the immune system
Demonstrates a favorable safety profile
No development of drug resistance observed in clinical trial participants
No anti-drug antibody (ADA) response detected in subjects
Effectively reduces total HIV nucleic acid levels in the human body
Achieves a 3-log reduction in viral load in viremic patients and maintains suppression for 16 weeks
No viral rebound observed during the trial period

Phase I Clinical Trial – Completed

Single-dose study design

20 treatment-naïve, asymptomatic HIV-positive participants

01
Phase IIa Clinical Trial – Completed

Two multiple-dose study designs

29 treatment-naïve, asymptomatic HIV-positive participants

02
Phase II Clinical Trial – Completed

Two multiple-dose study designs

Study details completed; focus on evaluating safety, efficacy, and viral suppression in broader patient populations

03

UB-421

Product Highlights

UB-421 not only holds the potential for achieving a functional cure, but also demonstrates outstanding efficacy in treating patients with multidrug-resistant HIV:

For patients with resistance to existing therapies, UB-421 as a monotherapy has shown significant therapeutic benefits.

Enhances the effectiveness of current treatments by blocking viral replication through multiple mechanisms, enabling effective combination therapy.

Rapidly reduces viral load during the early phase, achieving up to a 99% reduction in blood viral levels. This allows for a staged treatment approach, where UB-421 is combined with other broadly neutralizing antibodies or antiviral agents to strengthen long-term control.