Sino Biopharm (HK.1177) announced on March 8 that TDI01 suspension, a Class I innovative drug developed independently by its subsidiary Beijing Tide Pharmaceutical Co., Ltd, was approved by National Medical Products Administration on March 3, 2022 to conduct clinical trials for pneumoconiosis. According to the official website of the National Medical Products Administration Drug Review Center, TDI01 is an oral small molecule drug with a new target and a new mechanism, and is a highly selective Rho/Rho-related coiled-coil-forming protein kinase 2 (ROCK2) inhibitor, which is listed as a major new drug creation in the 13th Five-Year Plan of China. It is the first-in-class drug in the field of pulmonary fibrosis and non-alcoholic steatohepatitis, which are the indications for clinical trials.

Sino Biopharm was the first company in China to focus on the ROCK2 target. In October 2020, TDI01 was approved to conduct clinical trials for idiopathic pulmonary fibrosis in China, and this time for the second indication of pneumoconiosis. In 2021, TDI01 entered into an overseas licensing cooperation agreement with the US company Graviton Bioscience, with a total deal value of US$517.5 million, which set the highest record for foreign licensing of an oral small molecule drug in China at that time. TDI01 has completed Phase I clinical trials in the U.S. with a favorable safety profile, and is currently conducting a bridge trial in China, Tide revealed.

Promising relief for 900,000 pneumoconiosis patients

By the end of 2019, about 900,000 cases of pneumoconiosis have been reported nationwide, accounting for 90% of the total number of occupational diseases, and there are no effective therapeutic drugs and measures at home and abroad. The R&D team said that TDI01 has significantly improved pathological scores and lung function in pneumoconiosis models, and will actively promote its human clinical trial process, expecting to bring treatment gospel to pneumoconiosis patients as soon as possible.

Miss Tse, Theresa Y Y, Chairman of the Board of Directors of Sino Biopharm, said that as a pharmaceutical company, it has an important mission and responsibility to focus on the pneumoconiosis patient group, society is developing and they should not be left behind, and strengthening technological innovation and R&D is the best way for pharmaceutical companies to contribute their responsibility to society. The innovation transformation strategy X-LAB launched by Sino Biopharm last year will focus on FIC or first tier expected peak sales of not less than USD 500 million, with emphasis on differentiated dual and triple antibodies platforms, mRNA/DNA technology advanced vaccines and immune technology, and further build original and revolutionary innovative technologies on this basis. "We are confident that we can continue to enhance access to medicines for more patients and contribute to human health."