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United BioPharma obtained Taiwan FDA approval for conducting phase I clinical trial of its UB-221 product, a third generation monoclonal anti IgE antibody

Antibody targeting human IgE, UB-221, as a third generation anti IgE product, is approved by the TFDA for phase I clinical trial.

The primary objective of this phase I clinical trial was to evaluate clinical safety and initial efficacy of UB-221 in patients with Chronic Spontaneous Urticaria (CSU) who used urticaria first-line drugs but had no significant effect. Chronic spontaneous urticaria refers to hives with red, swollen, itchy symptoms for more than six weeks with unclear root, with possible recurrence for months and sometimes even years. According to the World Allergy Organization (WAO) in 2017, the global prevalence of chronic urticaria is about 1.8% [1], of which 60% are chronic spontaneous urticaria. The number of chronic spontaneous urticaria patients in the United States is estimated to be about 1.5 million [2]. Currently, the second-generation anti-histamine (H1-antihistamine) is used to treat chronic urticaria patient, however part of the patient population still has not improved their allergy condition.

The only biologic treatment approved by the Food and Drug Administration (FDA) in the United States for patients with chronic idiopathic urticaria is Xolair® (Omalizumab). UB-221 and Xolair® are both monoclonal antibodies acting on the IgE Cε3 domain, but epitopes recognized by both are different. In addition to neutralizing free IgE in the blood, UB-221 can effectively reduce IgE production by IgE bearing B cells. Many preclinical in vitro and in vivo experiments have shown better IgE binding characteristics and pharmacological effects for UB-221 in comparison to Xolair®. In addition, UB-221 has better ability to neutralize free IgE and a eight fold affinity that of Xolair®. UB-221 inhibits IgE production by approximately 2.5 times that of Xolair® with twice the half-life of Xolair®. Allergy is considered a lifestyle diseases in the 21st century, it cannot be prevented or cured at present. There are a wide range of allergy-related diseases, such as asthma (with approximately 240 million patient population worldwide); urticaria (about 380 million patients); and more than 220 million population with food allergy. Other allergies include those of rhinitis with approximately 400 million of patient population. For asthma medications, for example, the global market is over $10 billion, and allergic skin disease related drugs will reach $16.4 billion in 2025. In addition to chronic spontaneous urticaria, UB-221 can potentially treat other allergic diseases caused by IgE in near future, potential blockbuster.

About UB-221. UB-221 is an innovative humanized anti-IgE monoclonal antibody (IgG1) acting on the Cε3 domain of IgE immunoglobulin, neutralizes IgE and blocks by binding to IgE on the FcεRII (CD23) receptor. In a number of in vitro tests, UB-221 demonstrates three to eight times more potent than the anti-IgE antibody Xolair® (Omalizumab). In vivo experiments with human IgE transgenic mice showed that Xolair® required 10 times the concentration to achieve the same IgE concentration of IgG1 of UBP. UB-221 has completed preclinical testing and will enter the clinical phase I trial. Further UB-221 indications include chronic urticaria, asthma, allergic rhinitis, food allergies, atopic dermatitis and other allergies caused by IgE. UB-221 was originally invented by Dr. Tse-Wen Chang and team at the Academia Sinica, and is exclusively licensed to UBP for activities related to its commercialization.

About Chronic Spontaneous Urticaria (CSU). Chronic spontaneous urticaria is a hives phenomenon with symptoms of red, swollen, itchy papules which might last for more than six weeks. The cause is unknown, and sometimes it appears periodically and repeatedly, affecting patients' quality of life. Approximately 50% of patients with chronic urticaria are unable to improve or treat symptoms even with anti-histamine treatment. The global prevalence of chronic urticaria is about 1.8%, and about two-thirds of them are chronic spontaneous urticaria. About 1.5 million people in the United States suffer from chronic spontaneous urticaria.   
About United BioPharma (UBP). Established in September 2013, United Biopharma is a spinoff from its parent company UBI Asia within the UBI group. For more information, please visit the official