June 26, 2025, Shanghai, China – Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of oral iron-based phosphate binder, in dialysis patients with hyperphosphatemia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in serum phosphorus control with AP301. The safety profile of AP301 is favorable and consistent with previous studies.
As a novel fiber-iron-based phosphate binder, AP301 provides high phosphate-binding capability, no need to chew before swallowing, no volume expansion when exposed to gastric fluid, and no systemic absorption. These properties contribute to a reduced pill burden, good tolerability and improved patient compliance.
The pivotal study (NCT07030595, CTR20231624) is a randomized, open-label, active-controlled, multi-center phase 3 study designed to evaluate the efficacy and safety of AP301 in controlling serum phosphorus levels in dialysis patients with hyperphosphatemia. The 52-week study contains an active control phase, an AP301 low-dose control phase and an extended treatment phase. Sevelamer carbonate served as the active comparator throughout the whole study period. A total of 474 participants were randomized across 50 investigational sites in China; the study was led by Professor Li ZUO, Director of the Department of Nephrology at Peking University People’s Hospital.
“We are deeply grateful to all the participants, investigators, and study personnel for their strong commitment and dedication to this phase 3 study over the past 2 years.” Dr. Jin Tian, Co-founder and CMO of Alebund, commented, “In the completed phase 2 study, AP301 was shown to be safe, well tolerated, and can effectively lower serum phosphorus in a dose-dependent manner [1]. This pivotal trial further demonstrates the clinical value of AP301, which has the potential to advance the treatment option for millions of patients with hyperphosphatemia through further increasing their adherence.”
Alebund plans to engage with the China National Medical Products Administration (NMPA) regarding its new drug application plan in the third quarter of 2025. Detailed results from this phase 3 study will be presented at an upcoming medical conference.
Reference
[1] Bing Zhuang, Liangying Gan, Bin Liu, Weijie Yuan, Ming Shi, Ai Peng, Lihua Wang, Xiaolan Chen, Tongqiang Liu, Shiying Zhang, Song Wang, Qing Gao, Baoxing Wang, Huixiao Zheng, Changhua Liu, Yuan Luo, Hong Ye, Hongli Lin, Yiwen Li, Qiang He, Feng Zheng, Ping Luo, Gang Long, Wei Lu, Kanghui Li, Junwei Yang, Yingxue Cathy Liu, Zhizheng Zhang, Xiaoling Li, Weifeng Zhang, Li Zuo, Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis, Nephrology Dialysis Transplantation, Volume 39, Issue 10, October 2024, Pages 1649–1661.
About Hyperphosphatemia
Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphorus level could cause multiple complications such as secondary hyperparathyroidism, renal osteodystrophy and vascular calcification. It is an independent risk factor of cardiovascular events and all-cause mortalities. A good control of serum phosphorus level could effectively improve the patients’ outcome. For CKD patients undergoing dialysis treatment, the regular dialysis is not sufficient to remove the overload of serum phosphate in the body. Considering the limitations of low-phosphate diet which might cause dystrophia, oral use of phosphate binders is the prevailing treatment for hyperphosphatemia. However, there is low compliance for patients (less than 50% reaching good phosphate control) to use PBs due to gastrointestinal side effects, high pill burden etc.
According to Global and Chinese Hyperphosphatemia Drug Industry Blue Book by China Insights Consultancy in 2023, the out of target rate of serum phosphorus level in dialysis patients in Chinese mainland was significantly higher than other countries and regions. There is still room for improvement in terms of the proportion and duration of phosphorus binders usage. The market size of serum phosphorus lowering products in China is expected to reach 10 billion RMB by 2035.
About Alebund Pharmaceuticals
Alebund was incubated in Shanghai in 2018. It focuses on the discovery, development, production and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring greater therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal indications, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS) and autosomal dominant polycystic kidney disease (ADPKD). Alebund has completed the construction of its manufacturing site for small molecules in Yangzhou that will supply bulk of Alebund’s pipeline drugs, including AP301, upon commercial launch. Alebund has also established a dedicated commercialization team in China, responsible for the commercial promotion of renal products.
礼邦医药宣布 AP301 治疗透析患者高磷血症的关键性 Ⅲ 期研究达到主要疗效终点
2025 年 6 月 26 日，礼邦医药（“礼邦”或“公司”），一家专注于开发治疗肾脏疾病及相关慢性病创新药物的综合性生物制药公司，宣布其在研新型含铁口服磷结合剂 AP301 胶囊用于治疗透析患者高磷血症的关键性 Ⅲ 期临床研究已于 2025 年 6 月 16 日完成数据库锁库。该研究达到主要疗效及安全性终点。数据显示，AP301 在降低血清磷方面疗效显著，具有统计学和临床意义，且安全性和耐受性良好，未发现新的安全性信号。
作为一款以纤维-铁为基础的新一代口服磷结合剂，AP301 具有高效的磷酸盐结合能力，无需咀嚼，在胃液中膨胀体积小，无系统性吸收等优势。这些特点有助于减少患者每日服药数量，带来更好的安全性及胃肠耐受性，提升患者依从性。
本项关键性研究 （CTR20231624, NCT07030595）是一项随机、开放标签、阳性药物对照、多中心的 Ⅲ 期临床试验，旨在评估 AP301 对高磷血症透析患者血清磷控制的有效性和安全性。 整个研究治疗为期 52 周，包括阳性药物对照期，低剂量对照期和延长治疗期。碳酸司维拉姆作为阳性对照药物，在整个研究期间持续给药。该项研究在中国 50 家研究中心开展，共随机入组了 474 名受试者。北京大学人民医院肾内科主任、博士生导师左力教授担任该研究的主要研究者。
“我们衷心感谢所有试验受试者，研究者，研究中心和相关研究人员在过去两年里对本项 Ⅲ 期临床研究所给予的大力支持和付出。”礼邦医药联合创始人、首席医学官田劲医生表示：“在已完成的 Ⅱ 期研究中，AP301 展示出良好的安全性和耐受性，并能以剂量依赖的方式有效且快速降低血清磷水平 [1]。本项 Ⅲ 期临床研究进一步验证了 AP301 的临床价值。我们相信，作为新一代磷结合剂 AP301 有望进一步提升患者的依从性，并为数百万高磷血症患者提供更优的治疗选择。”
礼邦医药计划在 2025 年第三季度就 AP301 产品的上市申请同中国国家药品监督管理局开展沟通。该项 Ⅲ 期研究的详细结果将在即将召开的医学会议上公布。
参考文献
[1] Bing Zhuang, Liangying Gan, Bin Liu, Weijie Yuan, Ming Shi, Ai Peng, Lihua Wang, Xiaolan Chen, Tongqiang Liu, Shiying Zhang, Song Wang, Qing Gao, Baoxing Wang, Huixiao Zheng, Changhua Liu, Yuan Luo, Hong Ye, Hongli Lin, Yiwen Li, Qiang He, Feng Zheng, Ping Luo, Gang Long, Wei Lu, Kanghui Li, Junwei Yang, Yingxue Cathy Liu, Zhizheng Zhang, Xiaoling Li, Weifeng Zhang, Li Zuo, Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis, Nephrology Dialysis Transplantation, Volume 39, Issue 10, October 2024, Pages 1649–1661.
关于高磷血症
高磷血症是慢性肾脏病患者的重要并发症之一。血磷水平长期过高可导致甲状旁腺功能亢进、肾性骨病、血管钙化等多种并发症，是增加患者心血管事件和全因死亡的独立危险因素。控制血磷水平达标可有效改善慢性肾脏病患者的预后。对于慢性肾脏病接受透析治疗的高磷血症患者，即使规律透析也无法清除每日摄入磷酸盐在体内的蓄积量。由于饮食限磷的作用有限、且会影响患者的营养状况，口服磷结合剂是目前治疗高磷血症的主要方法， 但超过一半的患者血磷控制不佳，其中一个主要原因是现有磷结合剂的胃肠道副作用明显且服用药片数量过多，导致患者治疗依从性差。
根据灼识咨询 2023 年《全球及中国高磷血症药物行业蓝皮书》，中国在透患者血磷水平不达标率显著高于其他国家及地区，磷结合剂使用比例以及磷结合剂使用患者的用药时长方面均仍有较高提升空间。随着新一代降磷产品的上市，预计 2035 年中国降磷药物市场规模将达到百亿元人民币规模。
关于礼邦医药
2018 年初，礼邦医药孵化于中国上海。作为一家生物制药公司，礼邦主要致力于肾脏病以及其相关慢性疾病创新药物的发现，开发，生产和商业化，为全球慢性肾脏病及相关疾病患者提供更佳临床治疗方案。礼邦医药已经建立起了丰富且均衡的肾脏病新药产品管线，包括针对慢性肾病（CKD）/透析并发症、IgA 肾病、糖尿病肾病、局灶阶段性肾小球硬化（FSGS）、常染色体显性多囊肾病（ADPKD）等的产品。礼邦医药已在扬州建成并启用小分子药物生产基地，以支持礼邦管线产品包括 AP301 未来的商业化。同时，礼邦亦搭建了肾科专科销售团队负责相关产品的中国商业化推广。