Sino Biopharmaceutical's TQC3721 Inhalation Drug Receives Phase III Approval for COPD Treatment

Key Insights

• Sino Biopharmaceutical received approval from China's Center for Drug Evaluation to conduct phase III registration clinical studies for TQC3721, an innovative inhalable PDE3/4 inhibitor for COPD maintenance treatment.
• TQC3721 demonstrates dual bronchodilation and anti-inflammatory effects, with clinical research showing significant improvements in bronchodilation and St. George's scores compared to existing drugs targeting the same pathway.
• The drug represents only the second inhaled PDE3/4 inhibitor globally in development, with phase III trials planned to include a broader COPD patient population receiving various background treatments.

Sino Biopharmaceutical (01177.HK) has received regulatory approval from China's Center for Drug Evaluation (CDE) of the National Medical Products Administration to advance its innovative inhalation drug TQC3721 into phase III registration clinical studies for chronic obstructive pulmonary disease (COPD) maintenance treatment.

Novel Dual-Action Mechanism

TQC3721 is an inhalable PDE3/4 inhibitor that employs a new mechanism providing dual effects of bronchodilation and anti-inflammation. This dual action aims to alleviate patient symptoms while suppressing inflammation and controlling disease progression in COPD patients.

Clinical research results demonstrate that TQC3721 significantly improved bronchodilation effects and St. George's scores in COPD patients receiving background treatment with either single or dual bronchodilators. The drug has shown superior efficacy compared to existing drugs targeting the same pathway, with relevant data scheduled for presentation at an upcoming international academic conference.

Expanded Patient Population Coverage

The upcoming phase III clinical study will evaluate the efficacy and safety of TQC3721 inhalation suspension in a larger cohort of moderate to severe COPD patients under different background treatment scenarios, including no background treatment, single bronchodilator, or dual bronchodilator therapy.

Currently, only one inhaled PDE3/4 inhibitor has received market approval worldwide, positioning TQC3721 as the second globally in development progress. The phase III clinical trial design for TQC3721 will include patients receiving dual bronchodilator background treatment, thereby covering a broader population of COPD patients compared to existing products.

Multiple Formulation Development

Beyond the inhalation suspension formulation entering phase III trials, Sino Biopharmaceutical is simultaneously developing a TQC3721 inhalation powder inhaler currently in phase I clinical development. The dry powder formulation is expected to further enhance patient compliance, potentially offering additional therapeutic advantages in COPD management.