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Transcenta Holding Announces Approval to Initiate Phase II Clinical Trial of TST002 (Blosozumab)

Monday, July 31, 2023

Transcenta Holding announced that it has received approval from the China Centre for Drug Evaluation (CDE) to conduct a Phase II clinical trial of their drug candidate TST002, also known as Blosozumab. Blosozumab is a humanised anti-sclerostin monoclonal antibody intended for the treatment of osteoporosis and other bone loss diseases.

The Phase II clinical trial will focus on evaluating the safety, tolerability, and pharmacokinetics of TST002 after both single and multiple intravenous administrations. The study will involve patients with reduced bone mineral density, aiming to assess the drug's effects on bone health.

TST002, also known as Blosozumab, is a humanised anti-sclerostin monoclonal antibody that holds promise as a drug candidate for treating osteoporosis and other bone loss diseases. Its unique feature lies in its dual effect, possessing both anabolic and anti-resorptive properties. This means that it can stimulate bone formation while also inhibiting bone absorption, resulting in a rapid increase in bone mineral density (BMD) and bone strength.

By blocking the activity of sclerostin, a protein that negatively regulates bone formation, TST002 promotes bone-building processes, making it an effective approach in increasing BMD and reducing the risk of bone fractures.

Currently there is no approved anti-sclerostin antibody therapy in China yet although Romosozumab from Amgen has been approved in the United States, Europe and Japan.

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