ApicHope Pharmaceutical Group (300723.SZ): The Phase III clinical study of the innovative gout drug AR882 for treating patients with gout and hyperuricemia has reached its primary endpoint.

ApicHope Pharmaceutical Group (300723.SZ) announced that its wholly-owned subsidiary, Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd., has recently completed a top-line analysis of the Phase II/III clinical trial of AR882 (generic name: deuterated benzbromarone) capsules for the treatment of gout with hyperuricemia. Preliminary statistical results indicate that AR882 showed positive efficacy and good safety among participants with gout and hyperuricemia, with the trial results being ideal and meeting expected objectives. It is reported that AR882 is a Class I innovative drug under development by the company. It is a next-generation, highly selective urate transporter (URAT1) inhibitor with global competitiveness, aimed at reducing blood uric acid (sUA) levels by promoting the renal excretion of urate through the inhibition of urate reabsorption, thereby treating patients with gout and gout stones. AR882 overcomes the shortcomings of lesinurad and benzbromarone by binding long-term to urate transporters, extending the duration of its inhibitory effects, with clinical results indicating its efficacy lasts up to 24 hours. Furthermore, the all-day blockade of urate reabsorption does not increase the burden on the kidneys, avoiding nephrotoxicity and effectively eliminating uric acid from the body, achieving the goal of dissolving gout stones. Currently, the company holds 100% market rights for AR882 in the China region (including Hong Kong, Macau, and Taiwan) through its wholly-owned subsidiary, Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd., and has priority rights for global production supply of AR882 to Arthrosi Therapeutics, Inc. in the United States. The progress of the domestic Phase III clinical trial for AR882 will not have a significant impact on the company's recent performance.