Liansheng UB-221 was approved by the US FDA for phase I clinical license [Google Translation] (China Times) - Nov 11, 2019 - "Liansheng Pharmaceutical announced today that its new anti-IgE monoclonal antibody drug UB-221 has received FDA approval from Chronic Spontaneous Urticaria (CSU) patients who are ineffective in standard first-line drug H1 antihistamine therapy. Conduct a clinical phase I trial....This is a randomized, single-blind, placebo-controlled, single-dose, clinical trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of UB-221 as an add-on therapy. The clinical trial will accommodate 32 patients with CSU and receive a single dose of UB-221 for intravenous infusion."
IND • New P1 trial
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