AirNexis Therapeutics has announced that a Chinese Phase 2b study of AN01 (HSK39004) PDE3/4 inhibitor DPI in COPD patients that was conducted by Haisco Pharmaceutical met its primary endpoint. AirNexis launched in early 2026 with ex-China rights to develop inhaled formulations of HSK39004 acquired from Haisco.
AirNexis CEO Maria Fardis commented, “We are pleased to share safety and efficacy data from the Phase 2b study of AN01 DPI in COPD patients for the first time. The study met its primary endpoint, with AN01 significantly improving lung function versus placebo in patients on background standard-of-care therapy, including those already on dual bronchodilator therapy. No treatment-related adverse events were reported in the 0.75 mg dose, the dose under investigation in the Phase 3 program. These results reinforce AN01 DPI’s potential as a convenient, easy-to-administer treatment option for a broader COPD patient population.”
According to AirNexis, the company has already completed a Phase 1 trial of AN01 in Australia and plans to plans to initiate a Phase 2 trial in 2027. In addition, the company notes that Haisco is currently conducting a Phase 3 trial of the dry powder formulation in China.
Read the AirNexis Therapeutics press release
