中国生物制药：吸入用 TQC3721 混悬液 “PDE3/4 抑制剂” 获 CDE 批准开展 III 期注册临床研究
SINO BIOPHARM announced that its inhaled TQC3721 suspension "PDE3/4 inhibitor" has been approved by the CDE to conduct Phase III registration clinical research aimed at treating chronic obstructive pulmonary disease (COPD). TQC3721 has dual effects of bronchodilation and anti-inflammation, and clinical studies have shown its efficacy to be superior to that of drugs targeting the same pathway. The study will further observe its effectiveness and safety under different background treatments. COPD is the third leading cause of death globally, with approximately 100 million patients in China
According to the announcement from SINO BIOPHARM (01177), the group’s developed Class 1 innovative drug, the inhalation TQC3721 suspension "PDE3/4 inhibitor," has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China to conduct Phase III registration clinical research for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
TQC3721 is a novel mechanism inhaled PDE3/4 inhibitor that has dual effects of bronchodilation and anti-inflammation, thereby alleviating patient symptoms, suppressing inflammation, and controlling disease progression. Clinical research results show that TQC3721 significantly improves bronchodilation effects and St. George's Respiratory Questionnaire scores in COPD patients receiving background treatment with either a single bronchodilator (monotherapy) or dual bronchodilators (combination therapy), demonstrating efficacy superior to other drugs targeting the same pathway. Relevant data will be presented at an upcoming international academic conference. This Phase III clinical study will further observe the efficacy and safety of inhaled TQC3721 suspension in a larger sample of moderate to severe COPD patients under different background treatments (no background, monotherapy, or combination therapy).
COPD is the third leading cause of death globally, causing over 3 million deaths each year, and has become a significant public health challenge worldwide. In China, COPD is one of the chronic respiratory diseases that the country pays high attention to and is listed as a key prevention and control project in the "Healthy China 2030" action plan. Data shows that there are approximately 100 million COPD patients in China. Currently approved COPD treatment drugs have significant clinical limitations: long-acting bronchodilators (LABA/LAMA) can alleviate symptoms to some extent but lack anti-inflammatory effects to prevent disease progression; inhaled corticosteroids (ICS) have anti-inflammatory effects but have significant limitations in patient use, with applicable populations strictly restricted by GOLD guidelines.
Currently, there is only one inhaled PDE3/4 inhibitor approved for market use globally, and TQC3721 ranks second in the development progress worldwide. Compared to the already marketed products, the Phase III clinical trial of TQC3721 will additionally include patients receiving dual bronchodilator background treatment, covering a broader COPD patient population. In addition to the inhalation suspension, the TQC3721 inhalation powder is in the clinical Phase I development stage, and the dry powder formulation is expected to further enhance patient compliance
