China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to conduct a Phase III regulatory study for its TQC3721 as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

Drug Profile and Mechanism
TQC3721 is a novel inhaled PDE3/4 inhibitor with dual bronchiectasis and anti-inflammatory effects. The drug has demonstrated significant efficacy and symptom improvement in patients, outperforming other drugs targeting the same pathway. It shows promise whether used as a monotherapy or in combination with dual bronchodilator therapy.

Clinical Development
The company plans to further validate the safety and efficacy of TQC3721 in a larger cohort of moderate-to-severe COPD patients. Currently, TQC3721 is the second most advanced candidate in global development for inhaled PDE3/4 inhibitors. Additionally, TQC3721 inhalation powder has entered Phase I clinical trials, and its dry powder formulation is expected to enhance patient compliance.-Fineline Info & Tech