China’s Sino Biopharmaceutical Ltd (HKG: 1177) has announced that its subsidiary, Beijing Tide Pharmaceutical Co. Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for its in-house developed Category 1 drug TDI01. The targeted indication for the drug is COVID-19.
TDI01: Unique Mechanism and Development
TDI01 stands out from other anti-COVID-19 drugs currently in development globally. It is a Category 1 small-molecule oral COVID-19 therapy with a novel mechanism, target, and structure. TDI01 achieves antiviral effects by highly selectively inhibiting ROCK2 targets, thereby inhibiting viral invasion and replication. In both in vitro and in vivo animal experiments, TDI01 has demonstrated significant inhibitory effects on the novel coronavirus, alongside anti-inflammatory and anti-fibrotic effects.
Clinical Progress and Future Outlook
TDI01 has previously received approval for clinical studies in idiopathic pulmonary fibrosis (IPF) in China and the US, as well as for pneumoconiosis in China. The drug has completed a Phase I bridging study in China and concluded a Phase I study in the US with a good safety profile. The latest approval from the NMPA for COVID-19 clinical trials marks another significant milestone in the development of TDI01, positioning it as a potential new treatment option for COVID-19.-Fineline Info & Tech
