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United BioPharma Receives US FDA Approval for UB-221 Phase 1 IND for Chronic Spontaneous Urticaria

Taipei, Taiwan, November 8th , 2019 -- United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 1 clinical trial with a novel anti-IgE monoclonal antibody UB-221, in patients suffering from chronic spontaneous urticaria (CSU) that is not adequately controlled by standard first-line H1-antihistamine treatments. The lifetime prevalence of chronic urticaria is approximately 1.8%. Chronic spontaneous urticaria occurs in 0.5~1% of the population at any point in time. Two out of three cases of chronic urticaria are spontaneous, with its incidence peaking between 20 and 40 years of age .
The phase 1 trial is a randomized, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221 as an add-on therapy in 32 patients with moderate to severe CSU.
UB-221 has demonstrated its ability to neutralize free/soluble IgE with 8 folds higher affinity than that of another currently marketed anti-IgE monoclonal antibody therapeutic. In addition, UB-221 has shown to be more effective to down-regulate/reduce IgE synthesis through binding to CD23 receptor on B cell surface. A PK study in monkeys demonstrated two times longer serum half-life of UB-221 than that of the current therapeutic antibody drug. 
UB-221 is also being developed as the biologic therapeutic for other IgE-mediated allergies, including severe asthma, allergic rhinitis, severe food allergy and atopic dermatitis.

About UB-221
UB-221 is a humanized IgG1 that targets the Cε3 domain of IgE antibody. UB-221 is not only able to neutralize free/soluble IgE, but also to inhibit the IgE synthesis by binding to FcεRII (CD23) receptor on B cells surface. According to pre-clinical studies, UB-221 is superior to currently marketed therapeutic antibody targeting IgE by 3 to 8-folds in terms of pharmacologic effects. UB-221 was invented by Dr. Tse Wen Chang, who also previously involved significantly in the development of Omalizumab.

About chronic spontaneous urticaria (CSU)
Spontaneous urticaria is categorized into acute (less than six weeks) and chronic (more than six weeks) spontaneous urticaria. Chronic spontaneous urticaria (CSU) is also formerly known as chronic idiopathic urticaria (CIU) and chronic urticaria (CU). 0.5–1% of the population suffers from the disease at any time. Although all age groups can be affected, peak incidence is seen between 20 and 40 years of age. Chronic spontaneous urticaria has profound detrimental effects on quality of life, with sleep deprivation and psychiatric comorbidity being common. It also has a large impact on the economy in terms of direct and indirect health care costs as well as reduced performance at work. In the majority of patients, an underlying cause cannot be identified making a causal and/or curative treatment difficult. Nonsedating H1‐antihistamines are the mainstay of symptomatic therapy, however treatment with licensed doses relieves symptoms effectively in <50% of patients. Although guideline‐recommended updosing up to fourfold increases symptom control in many patients, a substantial number of patients have only little benefit from H1‐antihistamines. Hence, there is still a great need for new therapeutic strategies (Reference : Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GALEN task force report. Allergy. 2011;66 (3):317-330).

About United BioPharma
United BioPharma (UBP) is a clinical stage biopharmaceutical company, founded in 2013 as a spin-off from UBIAsia, its parent company. UBP is dedicated to research, development and manufacturing of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP’s Headquarter is located in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has a global team, highly passionate about developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable medicines to bring better life to the patients.
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United BioPharma Forward-Looking Statements
The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements.

Company contact:
Dr. Mei June Liao, Executive Vice President, Product Development
+886-3-5979288 # 6700