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UB-221

Product Description

Product Description UB-221 is a next-generation product developed by Dr. Tse-Wen Chang, the inventor of omalizumab. It is a fully human, original monoclonal antibody formulated for subcutaneous injection. UB-221 not only neutralizes free IgE, which triggers allergic reactions, but also regulates the surface molecule CD23 on B cells, thereby inhibiting IgE production.

Preclinical data have demonstrated that UB-221 possesses superior pharmacological properties compared to Xolair®: UB-221 can neutralize free IgE and also inhibit IgE production by binding to CD23 on B cells (whereas Xolair® only neutralizes free IgE); UB-221 is 8 times more effective than Xolair® in binding affinity to free IgE; in vitro cell experiments show that UB-221 is 2 to 5 times more effective than Xolair® in suppressing IgE production; in monkey studies, UB-221 demonstrated a serum half-life that is twice as long as that of Xolair®.

UB-221

Pharmacological
Mechanism

Common allergic diseases are closely related to IgE antibodies, which play a central role in allergic reactions. When the body is exposed to allergens, the immune system produces large amounts of IgE antibodies. Immune cells affected by IgE then release inflammatory mediators that trigger clinical symptoms, causing more than 30% of the population to suffer from such conditions.

UB-221

Current Disease
Landscape

Urticaria currently affects approximately 92 million people worldwide, with about 16 million cases in China alone. The annual growth rate of patients is 1.4%. At present, the primary treatment for urticaria relies on antihistamines, with dosage adjusted based on the severity of symptoms. If antihistamines prove ineffective, omalizumab is used as an adjunct therapy. However, omalizumab has drawbacks such as a slow onset of action and rapid relapse after discontinuation, making it difficult for urticaria patients to receive high-quality and long-term treatment.

92million patients

Global population distribution of urticaria
16million patients

Population affected domestically
1.4%

Annual growth rate of patients

UB-221

Product Overview

UB-221 is a next-generation product developed by Dr. Tse-Wen Chang, the inventor of omalizumab. It is a fully human, original monoclonal antibody formulated for subcutaneous injection. UB-221 not only neutralizes free IgE, which triggers allergic reactions, but also regulates the surface molecule CD23 on B cells, thereby inhibiting IgE production.

Preclinical data have demonstrated that UB-221 possesses superior pharmacological properties compared to Xolair®:
UB-221 can neutralize free IgE and also inhibit IgE production by binding to CD23 on B cells (whereas Xolair® only neutralizes free IgE);
UB-221 is 8 times more effective than Xolair® in binding affinity to free IgE;
in vitro cell experiments show that UB-221 is 2 to 5 times more effective than Xolair® in suppressing IgE production;
in monkey studies, UB-221 demonstrated a serum half-life that is twice as long as that of Xolair®.

UB-221

Product Advantages

Preclinical data clearly demonstrate that UB-221 has significantly superior pharmacological properties compared to omalizumab:

UB-221 not only neutralizes free IgE but also inhibits IgE production by binding to CD23 on the surface of B cells. Additionally, UB-221 exhibits an 8-fold higher binding affinity to free IgE in humans compared to omalizumab, resulting in more effective neutralization of free IgE.

In vitro cell studies have shown that UB-221 is 2 to 5 times more effective than omalizumab at blocking IgE production. In monkey models, UB-221 displayed a serum half-life twice as long as that of omalizumab, suggesting a longer-lasting therapeutic effect during treatment.

UB-221

Addressing Unmet
Needs

As a next-generation product, UB-221 effectively addresses the key limitations of current omalizumab therapies:

Limitations of Omalizumab
1	Delayed onset of efficacy leads to slow symptom relief
2	Symptoms remain uncontrolled in approximately 50% of patients at therapeutic doses
3	Rapid relapse after discontinuation
4	High dosing frequency causes inconvenience for patients
5	Ineffective in patients with high IgE levels or higher body weight

Advantages of UB-221
1	Visible clinical effect within 1–2 weeks after administration
2	Multiple mechanisms of IgE inhibition allow for more effective symptom control
3	Greater symptom stability post-treatment, with lower relapse risk
4	Reduced dosing frequency improves patients' quality of life
5	Greater tolerance to high IgE expression and body weight; efficacy not compromised