GA黄金甲

On September 26, Sino Biopharm announced that TDI01, a Class I innovative drug developed by the Group's subsidiary, Beijing Tide Pharmaceutical Co., Ltd., was approved by the State Drug Administration of China on September 23, 2022 to conduct clinical trials for COVID-19. TDI01 was previously approved for clinical trials in China and the U.S. for idiopathic pulmonary fibrosis and in China for pneumoconiosis. COVID-19 is its third approved indication and the Group will continue to explore the use of TDI01 in additional indications.

The mechanism of TDI01 is to inhibit viral invasion and replication through highly selective inhibition of ROCK2 target to achieve antiviral effects, which is a new antiviral mechanism with significant inhibition effect of neo-coronavirus in in vitro experiments and in vivo tests in animals; it also has anti-inflammatory and anti-fibrotic effects. TDI01 is a new mechanism, new target and new structure of class I small molecule oral novel coronavirus therapeutic drug, which has completed the phase I clinical trial in the U.S. with good safety, and has completed the phase I human race bridging trial in China.

The approval of TDI01 in the clinical trial for COVID-19 brings a new mechanism of potential treatment options for the global fight against novel coronavirus pneumonia. The approval of TDI01 in the clinical trials for three major indications in the respiratory field will further increase the product pipeline of Sino Biopharm's original new drugs in the respiratory field and bring new treatment options for patients with respiratory diseases.