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Bio-Thera Gets Chinese Nod To Proceed On Ustekinumab

China’s NMPA Gives Go-Ahead For Phase I Trial On Stelara Biosimilar

Executive Summary

China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.

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Australia’s NeuClone has reported the completion of subject visits in its Phase I trial for a biosimilar ustekinumab rival to Janssen’s Stelara, with favorable results seen ahead of the formal study report that is due in the third quarter of this year.

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