集团持续投资开发差异化创新产品。ABP-671是当前痛风及高尿酸血症治疗中潜在疗效优、安全性好的产品。治疗痛风及高尿酸血症的1类新药ABP-671的引进将填补集团痛风治疗产品的空白，将使集团创新药产品矩阵更加多元化。产品在风湿免疫科可与集团在售产品美泰彤（甲氨蝶呤注射液），在内分泌科和骨科可与益盖宁（依降钙素注射液）在专家网络与市场资源方面协同。凭藉集团成功的商业化经验、合规高效的商业化体系，产品如获批上市，将为中国痛风及高尿酸血症患者带来新的用药选择，满足兼具疗效与安全性药物的临床需求，提升疾病诊疗和操作实践，从而使患者受益，并预期对集团业绩产生积极正面影响。On December 2, Kangzhe Pharmaceutical (00867.HK) announced that on December 2, 2024, the group signed an exclusive commercial agreement with Hangzhou New Element Pharmaceutical Co., Ltd. through its wholly-owned subsidiary for the first-class new drug ABP-671 for the treatment of gout and hyperuricemia.
According to the agreement, the group has obtained the exclusive commercialization rights for the product in mainland China, the Hong Kong Special Administrative Region, and the Macao Special Administrative Region. The cooperation period begins on the effective date of the agreement, with a ten-year authorization period from the first approval of the product for listing in mainland China. Upon expiration of the authorization period, under specific conditions stipulated in the agreement, the authorization period may be automatically renewed for another ten years.
ABP-671 is an innovative first-class drug for the treatment of gout and hyperuricemia. It is currently undergoing Phase 2b/3 clinical trials for gout in China and overseas, acting by inhibiting urate transporter 1 (URAT1) to reduce renal reabsorption of uric acid. Results from two completed Phase 2 trials show that multiple dose groups of ABP-671 (1mg to 12mg) exhibit good efficacy and safety. The product administered once daily at 2mg may have comparable or superior efficacy to the highest doses of benzbromarone and febuxostat at 80mg. Uric acid reduction can be maintained around the clock with no serious safety concerns. The product is expected to provide gout and hyperuricemia patients with more effective and safer treatment options. Several patents related to compounds and applications of ABP-671 have been authorized in China.
The group continues to invest in developing differentiated innovative products. ABP-671 is a product with potential for superior efficacy and good safety in the current treatment of gout and hyperuricemia. The introduction of the first-class new drug ABP-671 for the treatment of gout and hyperuricemia will fill the group's gap in gout treatment products, making the group's innovative drug product matrix more diverse. The product can synergize with Mattel (methotrexate injection), an existing product in rheumatology and immunology, and with Yigaining (calcitonin salmon injection) in endocrinology and orthopedics in terms of expert networks and market resources. With the group's successful commercialization experience and efficient commercialization system, if the product is approved for listing, it will bring new medication options to Chinese gout and hyperuricemia patients, meeting clinical demands for drugs with both efficacy and safety, improving disease diagnosis and treatment practices, benefiting patients, and is expected to have a positive impact on the group's performance.
