Lee's Pharmaceutical Holdings Limited announced that, on 18 August 2023, a phase IIa clinical trial of a fentanyl aerosol for inhalation conducted by Zhaoke Pharmaceutical (Guangzhou) Limited (Zhaoke Pharmaceutical (Guang Zhou)You Xian Gong Si), a wholly-owned subsidiary of the Company, reached its expected endpoints. This clinical trial was a phase IIa clinical trial to assess the safety and effectiveness of the fentanyl aerosol for inhalation in Chinese patients with breakthrough cancer pain (" BTCP"). The primary endpoint of this trial was to initially assess the dose-response relationship and determine the range of effective dose of fentanyl aerosol in the treatment of BTCP.

The secondary endpoint was to verify the safety of fentanyl aerosol and the reliability, dependability and safety of the inhaler. This trial was designed as a multi-center, randomized, double-blinded, self-crossover study. A total of 60 patients were successfully enrolled from 13 participating centers.

The results of the treatment demonstrated that the response of the tested group was better than that of the placebo group with statistical significance. This trial also verified the safety and tolerability of the fentanyl aerosol for inhation. The results of this trial will be used to expedite the review and approval procedures for national new drug approval with the aim of launching the product as soon as possible in order to meet the medical need of patients with BTCP.