Apichope Pharmaceutical Group Co.,Ltd. (300723.SZ) has announced that its wholly-owned subsidiary, Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd., recently obtained top-line data from a Phase II/III clinical trial of AR882 (generic name: Deuterium-Benorilate) capsules in patients with gout and hyperuricemia.

The preliminary results indicate that AR882 demonstrated positive efficacy and a favorable safety profile among trial participants, with outcomes meeting expectations and achieving the intended study objectives.

AR882 is the company's first-in-class innovative drug candidate and a next-generation, highly selective urate transporter 1 (URAT1) inhibitor with global competitiveness. The drug works by inhibiting uric acid reabsorption to promote renal excretion of urinary urate, thereby lowering serum uric acid (sUA) levels for the treatment of gout and tophi.

Compared with lesinurad and benzbromarone, AR882 overcomes their limitations by binding durably to urate transporters, extending the inhibitory effect, with clinical results showing efficacy lasting up to 24 hours. Moreover, around-the-clock blockade of uric acid reabsorption does not increase renal burden, helps avoid nephrotoxicity, and effectively clears uric acid from the body to achieve dissolution of tophi.

The company currently holds 100% market rights to AR882 in China (including Hong Kong, Macau, and Taiwan) through its wholly-owned subsidiary Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd., and also has priority rights to provide global manufacturing supply of AR882 to Arthrosi Therapeutics, Inc. in the United States.

Progress of the domestic Phase III clinical trial for AR882 is not expected to have a material impact on the company's near-term financial results.