China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase II clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its drug TST002 (blosozumab) in Chinese patients with decreased bone density. This development follows encouraging Phase I clinical data for the drug.
TST002’s Dual Mechanism of Action
TST002 is a drug with a dual mechanism of action that generates both anabolic and anti-resorptive effects. It stimulates bone formation while simultaneously inhibiting bone absorption, leading to a rapid increase in bone density and bone strength. This unique approach positions TST002 as a potential treatment for patients with conditions affecting bone density.
Following in the Footsteps of Romosozumab
Transcenta aims to follow the success of Amgen’s anti-sclerostin monoclonal antibody Evenity (romosozumab), which has been approved in the US, Europe, and Japan and is currently under clinical development in China. TST002, in-licensed from Eli Lilly in 2019, is intended for development and commercialization in Greater China. The drug has already concluded Phase II studies in postmenopausal women in the US and Japan, adding to the body of evidence supporting its potential efficacy and safety.-Fineline Info & Tech
