Sevelamer Carbonate

Clinically and statistically significant superiority of AP301 maintenance dose versus ineffective low dose in reducing serum phosphate levels was established and AP301's efficacy is sustained throughout the 52 weeks of treatment. The non-inferiority of AP301 to sevelamer carbonate in reducing serum phosphate levels was demonstrated. Overall, AP301 was safe and well-tolerated. The most common AEs were discolored feces and diarrhea. Diarrhea generally occurred early and resolved without treatment changes. No evidence of iron accumulation was observed with cumulative AP301 exposure. SHANGHAI, Nov. 7, 2025 /PRNewswire/ -- Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, presented the pivotal phase 3 study results of AP301 in patients on hemodialysis and peritoneal dialysis with hyperphosphatemia (RESPOND-1 study, NCT07030595) at the American Society of Nephrology (ASN) 2025 Congress in Houston, Texas. Continue Reading Figure 1 Difference of Change in Serum Phosphate from Baseline Figure 2 Change of Serum Phosphate during LD Phase* (*Data are presented as mean±SE) Figure 3 Change of Serum Phosphate over time* (*Data from LD phase was excluded; Data are presented as mean ±SE) AP301 is a novel fiber-iron-based phosphate binder that offers high phosphate-binding capability, does not require chewing before swallowing, does not expand in volume when exposed to gastric fluid, and is not systemically absorbed. These features contribute to a reduced pill burden, improved tolerability, and enhanced patient adherence. The RESPOND-1 study was a randomized, open-label, active-controlled, multi-center study designed to evaluate the efficacy and safety of AP301 in controlling serum phosphate levels in dialysis patients with hyperphosphatemia. The 52-week study included an active control phase, an AP301 low-dose control phase, and an extended treatment phase. Sevelamer carbonate served as the active comparator throughout the entire study period. The study was conducted at 50 investigational sites in China, and was led by Professor Li ZUO, Director of the Department of Nephrology at Peking University People's Hospital. In this study: Of 692 participants screened, 474 participants were randomized (3:1) to the AP301 or sevelamer carbonate arm; 187 eligible participants in AP301 arm were further re-randomized (1:1) at Week 24 to the AP301 maintenance dose (N=94) or low dose (N=93) arm. Overall, 396 (84%) participants completed the study. The primary efficacy endpoints included: 1) the change in serum phosphate levels during the low dose control phase from Week 24 to Week 27 between the AP301 maintenance dose and low dose arm in responders defined as serum phosphate level <1.78 mmol/L (5.5 mg/dL) by Week 20; 2) the change in serum phosphate levels from baseline to Week 12 between AP301 and sevelamer carbonate during active control phase. At week 12, AP301 demonstrated non-inferiority to sevelamer carbonate, with a least squares mean (LSM) difference of -0.02 mmol/L（95% confidence interval (CI): -0.10, 0.06）[-0.06 mg/dL (95% CI: -0.31, 0.20)]; the upper CI bound of 0.06 mmol/L (0.20 mg/dL) was below the pre-defined non-inferiority margin (NIM) of 0.19 mmol/L (0.59 mg/dL). (see Figure 1) At week 27, AP301 maintenance dose showed a clinically and statistically significant superiority on serum phosphate control over an ineffective AP301 low dose in the low dose control phase {LSM difference -0.58 mmol/L (95% CI: -0.69, -0.47; P <0.001) [-1.8 mg/dL (95% CI: –2.1, –1.5; P <0.001)]}. (see Figure 2) AP301 achieved robust and sustained serum phosphate reduction over 52 weeks, suggesting its long-term therapeutic benefit (See Figure 3). It also showed a numerically higher serum phosphate response rate in the AP301 arm (66.7%) compared to the sevelamer carbonate arm (58.6%) at Week 52, and with a lower mean daily dose exposure (6.52 g/day in AP301 versus 7.56 g/day in sevelamer carbonate). Most participants experienced at least one AE (96.3% in AP301 and 90.8% in sevelamer carbonate). Diarrhea was the most common AE leading to study discontinuation in the AP301 arm (2/355, 0.6%), typically occurring within the first 2–4 weeks and predominantly mild in severity. Iron parameters changed from baseline mainly during the first 24 weeks, then stabilized or decelerated thereafter. No evidence of iron accumulation was observed with cumulative AP301 exposure. Presentation Details at The American Society of Nephrology (ASN) 2025 Congress Date: November 6, 2025 Title: 52-Week Phase 3 Study to Evaluate the Efficacy and Safety of a Novel Iron-Based Phosphate Binder AP301 in Patients on Dialysis with Hyperphosphatemia "Iron-based phosphate binders have been used with increasing frequency in recent years for certain advantages. As a new generation of iron-based phosphate binder, AP301 is well differentiated from other iron-based phosphate binders with no systemic absorption and no need to chew or crush before swallowing. This pivotal trial demonstrates the clinical value of AP301 and its potential to advance the treatment option for patients with hyperphosphatemia." Dr. Jin Tian, Co-founder and Chief Medical Officer of Alebund, commented, "Alebund is actively engaging in discussions with the China National Medical Products Administration regarding the new drug application plan for AP301." About Hyperphosphatemia Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphate levels 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. Good control of serum phosphate levels could effectively improve the patients' outcome. For CKD patients undergoing dialysis treatment, regular dialysis is not sufficient to remove the excess 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, existing phosphate binders lead to low patient compliance, with less than 50% of patients achieving good phosphate control, due to gastrointestinal side effects and high pill burden, etc. According to the Global and Chinese Hyperphosphatemia Drug Industry Blue Book by China Insights Consultancy in 2023, the out-of-target rate of serum phosphate level in dialysis patients in Chinese mainland was significantly higher than that in other countries and regions. There remains substantial room for improvement in terms of the proportion of patients using phosphate binders and duration of their usage. The market size of serum phosphorus-lowering products in China is expected to reach RMB10 billion by 2035. About Alebund Pharmaceuticals Alebund was founded in Shanghai in 2018. The Company focuses on the discovery, development, manufacturing, and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring better therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of seven drug candidates and one commercialized product (Mircera ®) targeting a broad range of renal indications, including chronic kidney disease (CKD) and CKD complications, such as hyperphosphatemia, renal anemia, 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 in Yangzhou that will supply both drug substance and drug products of our product candidates, including AP301, upon commercial launch. Alebund has also established a dedicated in-house commercialization team in China responsible for promoting our renal products. SOURCE Alebund Pharmaceuticals 21% more press release views with Request a Demo

大家好，今天咱们来聊点医药圈的“八卦”——诺华刚刚官宣，把自家两款眼科产品诺适得和倍优适在中国的独家进口、推广和分销权，打包交给了康哲维盛，为期五年。 消息一出，业内同仁们是不是有种“似曾相识”的感觉？没错，这可不是诺华一家在玩这手，罗氏、赛诺菲、辉瑞等大佬们早就开始了这场“转让潮”。 罗氏把希罗达交给亿帆医药，赛诺菲把克赛、诺维乐甩给上药，协和麒麟干脆退出中国把业务卖给维健医药……这一连串操作，乍一看像是跨国药企在“甩包袱”，但仔细一琢磨，这分明是一场精心策划的“双赢棋局”！对于跨国药企来说，可以轻装上阵，聚焦核心赛道。先说说“诺华”们为啥要这么干。想象一下，你是一个跨国药企的CEO，手里攥着一堆产品线，有的像“现金牛”一样稳定赚钱，有的像“创新星”一样潜力无限。但资源有限啊，总不能全都亲力亲为吧？于是，诺华们一拍脑袋，咱们得“聚焦”！把那些成熟产品交给本土伙伴去打理，自己腾出手来专攻心血管、肿瘤、神经科学这些核心领域。这可不是瞎折腾。举个例子，诺华把眼科产品转让给康哲维盛，就像学霸把已经掌握的知识点交给学弟学妹去复习，自己则埋头攻克新难题。毕竟，在带量采购、医保谈判等政策压力下，成熟产品的利润空间被不断压缩，与其硬扛，不如交给更懂本土市场的玩家去运营。 再说，还能换回一笔可观的转让费或分成收入，何乐而不为？UCB把神经系统和抗过敏产品卖给康桥资本和穆巴达拉，估计也是打着“现金回血，专注创新”的算盘。对于本土药企来说，这就像捡漏了“满级号”，可以快速扩张版图。再来看接盘的“康哲维盛”们。对这些本土药企来说，这简直是“天上掉馅饼”！诺适得和倍优适可不是什么无名小卒，而是经过市场验证的成熟产品，拥有稳定的医生和患者群体。接手这些产品，就像在游戏里直接捡到一个“满级号”，省去了前期研发、审批、市场教育的漫长过程。亿帆医药接过罗氏的希罗达，上药接手赛诺菲的克赛，都是看中了这些产品已有的市场份额和品牌影响力。通过整合自身的渠道优势和成本控制能力，本土药企能让这些老树发新芽。 比如，康哲维盛凭借对基层市场的渗透力，说不定能让诺适得和倍优适的销量再上一层楼。爱尔康用8款药物换欧康维视16.7%的股份，更是“资源置换”的经典案例——既清理了库存，又投资了未来。这是一场双赢的局面。这场转让潮的背后，是医药行业生态的深刻变革。 首先，政策环境在倒逼企业转型。带量采购、医保控费让跨国药企的成熟产品利润大不如前，而创新药研发又烧钱如流水。与其守着“鸡肋”，不如转让给更擅长成本控制的国内企业。其次，市场分工越来越明确。跨国药企擅长从0到1的突破，而本土药企在从1到N的推广上更具优势。康哲维盛们更懂中国医院的“玩法”，能通过灵活的营销策略和渠道下沉，挖掘出产品的剩余价值。最后，效率提升是硬道理。对跨国药企来说，剥离成熟产品意味着更精简的团队和更聚焦的战略；对本土药企而言，接手成熟产品能快速补充产品线，提升营收规模。辉瑞把克唑替尼等产品交给华润，就是看中了华润的渠道网络能覆盖更广阔的市场。旧王退位，新王登基？不，是共治天下！所以，别再觉得跨国药企转让产品是“败退中国”了。这分明是一场高手之间的“接力赛”——跨国药企跑完创新第一棒，本土药企接过市场推广第二棒。 最终，患者能更快用上药，医院能有多元选择，双方企业还能各取所需。就像诺华在内部信里说的：“唯有明确方向，顺势而为，保持敏捷与聚焦，方能行稳致远。”未来，这种“跨国研发+本土商业化”的模式可能会成为常态。毕竟，在医药这个江湖里，没有人能通吃全场，合作才是王道。至于咱们打工人？别慌，公司转型的同时，记得把自己的技能树点多几个分支——毕竟，唯一的不变就是持续的变！ 正如诺华中国区总裁李尧所言：“我们始终在思考如何为患者创造更多价值。每一点改变都有意义，我们也一定能做得更好。”