Zhitong Finance App News, China Biopharmaceutical (01177) announced that the key registration phase III clinical trial (PACER-III) of the national Class 1 innovative drug TQC3721 inhalation suspension “PDE3/4 inhibitor” independently developed by Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Zhengda Tianqing), a subsidiary of the Group, for the maintenance and treatment of chronic obstructive pulmonary disease (COPD) has recently completed the enrollment of all subjects.
TQC3721 inhalation suspension is a PDE3/4 dual-target inhibitor. Phosphodiesterases (PDES) are a superfamily of enzymes that regulate various pathological and physiological processes by catalyzing the hydrolytic inactivation of adenogane cyclic phosphate (cAMP) and cyclic orangane phosphate (cGMP). Among them, PDE3 is highly expressed in airway smooth muscle, while PDE4 is widely expressed in various inflammatory cells. TQC3721 works through a dual mechanism: on the one hand, it promotes airway smooth muscle relaxation to improve ventilation, and on the other hand, it suppresses inflammatory response, thereby effectively controlling disease progression.
COPD is a lung disease characterized by chronic respiratory symptoms (dyspnea, cough, phlegm). The core pathogenesis is chronic airway inflammation and persistent airflow obstruction. COPD is the third leading cause of death in the world, with more than 391 million cases. Currently, COPD treatment is mainly based on long-acting muscarinic antagonists (LAMAs) and long-acting beta-2 agonists (LABA), which can improve lung function, but the curative effect on airway inflammation is limited. As the main treatment for chronic inflammatory airway diseases, inhaled glucocorticoid (ICS) can reduce acute exacerbation in combination with LABA or LAMA, but it has limited benefit for patients with low eosinophil counts and increases the risk of pneumonia. Therefore, there is an urgent need to develop novel drugs that are both anti-inflammatory and improve airflow obstruction.
As an innovative inhalation formulation, TQC3721 has two dosage forms: atomized inhalation suspension and dry powder inhalation powder, which can be adapted to different patient groups, disease severity and commercial application scenarios. For COPD, TQC3721 atomized inhalation suspension has shown the best potential in its class in phase II studies. The dosage form has now completed phase III clinical enrollment, and the dry powder inhalation powder has also been promoted to phase II clinical trials. It is expected to become the first domestically produced inhaled PDE3/4 dual inhibitor approved for marketing in China.