August 8, 2022

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Zenas BioPharma Obtains IND Approval in China for Phase 1/2 Study of ZB001 for the Treatment of Thyroid Eye Disease

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WALTHAM, Mass and SHANGHAI, China, July 31, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, announced that it has received approval of its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA) of China for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). The main objective of the Phase 1/2 is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.

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TED is a debilitating vison-threatening autoimmune disease that causes inflammation and fibrosis within the orbit of the eye. With no approved therapies for TED patients in China, treatment options are limited and often involve high doses of steroids associated with serious side effects or surgical intervention. ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) intended for the treatment of TED.

“We are proud that the IND application for ZB001 was approved by the NMPA about two months following its submission, highlighting our team’s unique ability to efficiently execute on our development programs,” said Hua Mu, MD, PhD, Chief Executive Officer at Zenas. “We are…

GlobeNewswire

2022-07-31 19:02:53

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