Hangzhou Sciwind Biosciences Co., Ltd., (Sciwind), a clinical-stage, fast-growing biotech focusing on research and development of innovative biologics, today announced that XW003, a potential candidate for the treatment of non-alcoholic steatohepatitis NASH, has been approved by China NMPA for clinical trial. Two additional clinical trial applications with XW003 were previously approved for the treatment of type 2 diabetes mellitus and overweight/obesity in 2020.
In 2020, Sciwind completed phase 1 trial of XW003 at an overseas clinical site, which had demonstrated promising safety, tolerability, pharmacokinetics and pharmacodynamics profiles. Sciwind will initiate a series of phase 2 trials involving multiple metabolic indications, including diabetes, obesity and NASH, etc.
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“We are glad to receive the clinical trial approval of XW003 for NASH therapy by China NMPA,” said Hai Pan, PhD, Sciwind’s founder and CEO. “Obesity, diabetes and NASH are a collection of closely related, chronic metabolic disorders sharing similar pathogenesis. XW003 can improve the metabolic condition through multiple mechanisms of action. We are preparing a rapid development plan to obtain more clinical data and hope that this therapy can finally improve lives of NASH patients.”
Sciwind Biosciences is focusing on the therapeutic area of chronic metabolic and immunological diseases and devotes to research and development of global First- or Best-in-Class biologics. Sciwind owns multiple proprietary technologies, including oral peptide and inhaled protein therapeutics platforms. Sciwind has established a series of R&D pipelines based on these core platform technologies. Reuters