A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants With Knee Osteoarthritis Pain

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be 6 weeks.
* The visit frequency will be twice weekly during treatment.
* The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period.
* Approximately 466 participants will be enrolled into this study.

开始日期2025-05-29

申办/合作机构

Paradigm Biopharmaceuticals Ltd.

CTRI/2024/01/061184

/ Not yet recruiting临床2期IIT

A randomized, open-label, parallel, Proof of concept, Investigator Initiated study to evaluate the efficacy and safety of Pentosan polysulfate sodium in adult patients with Diabetic Nephropathy - NIL

开始日期2024-01-11

申办/合作机构-

ACTRN12621000654853

/ Recruiting临床2期IIT

A Double-Blind, RandoMised, Placebo-Controlled Study to Assess theEfficacy and Safety of oRal deliVery of sodium Pentosan Polysulfate (PPS)compared to placebo in participants with symptomatic kneE osteoarthritis(OA) and dysLipidemia (MaRVeL Study)

开始日期2023-07-05

申办/合作机构

The University of Sydney

100 项与木聚硫钠相关的临床结果

登录后查看更多信息

100 项与木聚硫钠相关的转化医学

登录后查看更多信息

100 项与木聚硫钠相关的专利（医药）

登录后查看更多信息

1,155

项与木聚硫钠相关的文献（医药）

2026-06-01·MARINE POLLUTION BULLETIN

Hepatic fatty acid fingerprints as biomarkers of persistent pollutant exposure in the ubiquitous blue shark (Prionace glauca)

Article

作者: Fernandes, Ana ; Novais, Sara C ; Muñoz-Arnanz, Juan ; Lemos, Marco F L ; Jiménez, Begoña ; Simões, Tiago ; Alves, Luis M F

Sharks exhibit remarkable species diversity, with most functioning as apex predators, making them particularly vulnerable to bioaccumulation of persistent pollutants (PPs). The ubiquitous blue shark (Prionace glauca) in particular, shows a strong capacity to accumulate contaminants that persist in marine ecosystems. Considering the biological relevance of fatty acids (FAs) and their potential interaction with pollutants, this study aimed to characterize hepatic FAs in 43 juvenile specimens and correlate them with two major PP classes to better understand their interactions and effects. An integrative Pollution Load Index (PLI), adapted from the literature and used here as a relative index of cumulative contamination, revealed that individuals were potentially in a concerning contamination state. Significant correlations were observed between PPs and specific FAs: positive associations with monounsaturated fatty acids such as oleic, erucic, and trans-FAs, and negative correlations with highly unsaturated fatty acids, mainly omega-3. These patterns reflect previously reported hepatic injuries and suggest a potential link between PP exposure and altered lipid metabolism or stress-related membrane remodeling, essential for the species' health and longevity. However, direct causal mechanisms cannot be inferred from the present data. Notably, trans-FAs, often overlooked in ecological studies and known for adverse health impacts, were strongly linked to increasing pollutant levels, especially persistent organic pollutants (POPs). The study further highlights that distinct fatty acid profiles and the membrane Double Bond Index can serve as reliable indicators of contamination stress and injuries. Overall, these findings provide valuable insight into how PPs affect essential lipid molecules in P. glauca, enhancing understanding of pollutant impacts on both coastal and deep-water marine organisms.

2026-06-01·COLLOIDS AND SURFACES B-BIOINTERFACES

An adjuvant codelivery nanosystem using Poria cocos polysaccharide for strengthened antitumor immunophototherapy

Article

作者: Zhang, Zili ; Yang, Xingxin ; Zhang, Mei ; Wang, Shuo ; Shi, Linxuan ; Bai, Yueping ; Zhang, Fan ; Meng, Meng ; Ma, Yiping ; Cui, Feifei ; Yu, Jie ; Song, Zhaorui ; Song, Chengzhu

As novel anticancer treatment, phototherapy has recently shown promising immunotherapy effect. However, photodynamic (PDT) or photothermal (PTT) alone is not sufficient to achieve satisfactory anticancer immunities. Certain polysaccharides can stimulate immune responses, but its application as an adjuvant in anticancer phototherapy has not been clearly studied. In this study, we established PLGA nanoparticles (PPS-ICG@PLGA NPs), loading polysaccharides from Poria cocos (PPS) as adjuvant, and using ICG as phototherapeutic molecule to study its anticancer immunities. The PPS was proved to enhance the ICD and immunomodulatory activity of the nanoparticle. Following intravenous injection, the PPS-ICG@PLGA NPs can accumulate in tumor site up to 24 h. Under NIR laser irradiation, the PTT/PDT associated with PPS induced cascade anticancer effects to activate cytotoxic T lymphocytes (CTLs). In vivo antitumor studies confirmed that the administration of PPS-ICG@PLGA NPs increased the ratio of CD4⁺ and CD8⁺ T cells in both tumor and spleen, enhanced DCs maturation in tumor and reversed the intratumor infiltration of regulatory T cells (Tregs) in tumor. These results demonstrate the application potential of PPS in promoting the immunotherapy efficacy of phototherapy, and also propose PPS-ICG@PLGA as a promising nanosystem for photoimmunotherapy.

2026-04-01·FOOD RESEARCH INTERNATIONAL

Beyond animal proteins: Insights into the functionality, quality impact, and innovation trends of plant-based proteins in emulsified sausages

Review

作者: Zhang, Xuehua ; Li, Guanglei ; Yang, Yang ; Huang, Ming ; Zhu, Zongshuai ; Wang, Hui

Growing consumer demand for healthier, more sustainable foods is driving the use of plant proteins (PPs) as alternatives to animal proteins in emulsified sausages. Traditional sausage formulations are prone to quality defects such as water-fat separation, a problem that PPs can effectively mitigate via their inherent emulsifying and gelling properties. However, a comprehensive understanding of the structure-function relationships, modification strategies, and practical application limitations of PPs is urgently required to facilitate targeted innovation in this field. This article synthesizes the current state of knowledge regarding the application of PPs in emulsified sausages, with a specific focus on the interplay between protein characteristics (i.e., source and molecular structure), processing conditions, and the quality attributes of the final products. It further evaluates strategies for enhancing PP functionality and addresses key challenges encountered throughout the product development process. Findings confirm that PPs enhance the textural properties, emulsion stability, and nutritional value of emulsified sausages by forming composite gel networks and stabilizing oil-water interfaces. The functional performance of soy, pea, and other PP sources is inherently correlated with their molecular structures, which can be tailored through targeted processing modifications. Despite these favorable attributes, several key obstacles persist, including undesirable sensory profiles, inconsistent adaptability to industrial processing conditions, and inherent allergenic potential. Overcoming these barriers will require focused research efforts on protein modification technologies, multi-component formulation design, and the targeted refinement of organoleptic properties, thereby accelerating the advancement of plant-based meat products.

项与木聚硫钠相关的新闻（医药）

2026-03-31

·深圳大百汇生命健康产业园

“汇”报 | 生命与健康产业研究月报（3月）

融投与合作空山慈科技完成Pre-A轮融资，加速脑机交互神经调控平台临床转化近日，专注无创脑机接口与神经调控的上海空山慈科技有限公司（以下简称“空山慈科技”）宣布完成Pre-A轮融资。本轮由云启资本独家领投，所募资金将主要用于核心技术研发、临床转化及全球化拓展。程天科技再获亿元级B+轮融资，加速外骨骼“人机融合”新消费时代杭州程天科技发展有限公司（以下简称“程天科技”）完成了亿元级B+轮融资，此为公司在一年内连续完成的第二轮融资。本轮由农银资本领投，汇川产投、杭州资本跟投。易慕峰完成近2亿元Pre-IPO轮融资，聚焦实体瘤治疗领域全球创新型细胞治疗公司易慕峰生物完成近2亿元人民币Pre-IPO轮融资。本轮融资由高榕创投、济峰资本领投，深天使、明道投资共同参与，老股东约印医疗基金持续加注。亦立医药完成新一轮近亿元人民币融资，加速推进新靶点项目研发与临床转化 3月12日，杭州亦立医药有限公司（以下简称“亦立医药”）宣布完成新一轮近亿元人民币融资，本轮融资由隆峰创投、亦成投资、弘盛资本、贝壳基金共同投资。所募资金将主要用于支持公司新靶点项目的分子发现、技术平台建设与临床转化，助力创新管线向临床阶段稳步迈进。炫景生物完成超2亿元Pre-A轮融资 2026年3月20日，临床阶段的小核酸药物公司炫景生物宣布，完成由康君资本领投的超2亿元Pre-A轮融资，德联资本、华泰金斯瑞基金、金易赋新、国海创新资本、联想创投和现有股东元希海河共同参与本轮投资。博思得完成超亿元C轮融资，领跑国产医疗核心部件赛道苏州博思得电气有限公司（以下简称“博思得”）作为国内X光影像核心部件领军企业，宣布完成超亿元C轮融资，由上海瑞力领投，交银资本、元璟资本等跟投。政策法规 2026年政府工作报告释放三大医疗政策信号首先，优化医疗机构功能定位和布局。近年来，卫健系统持续推进医疗资源优化布局。2026年全国卫生健康工作会议进一步明确“强基、稳二、控三”的原则，系统概括了当前的工作方向。通过严格控制三级医院的院区数量、床位规模等，抑制其无序扩张，有助于缓解大医院对人才和患者的“虹吸效应”。同时，需要持续提升基层诊疗能力，使常见病、多发病在基层能够得到有效诊治。其次，打造生物医药新兴支柱产业。当前，生物医药产业界一方面持续加大科技创新力度，针对新靶点、新化合物、新机制开展科技攻关，在继续发挥快速跟随优势的同时，做更多原始创新方向的突破；另一方面正加速推进国际化，通过多种方式开拓海外市场，中国的生物医药产业正站在全球化的起点，未来中国生物医药产业在全球的市场份额有望大幅提升。最后，优化医药集中采购。医药集采旨在通过压缩药品流通环节成本，直接降低群众用药负担，提升医保基金使用效率，引导医保为药品的临床价值付费。同时，该政策也致力于形成市场倒逼机制，推动医药企业转向创新驱动发展。2025年以来，国家医保局在持续优化集采规则，在2025年10月开展的第十一批集采中，国家设置了“锚点价”避免极端低价。目前，医药集中采购已进入优化新阶段，政策导向从灵魂砍价转向稳临床、保质量、防围标、反内卷的系统重构。创新与研发罗氏单抗疗法达肾病3期试验主要终点罗氏（Roche）近日宣布，其在成人原发性膜性肾病患者中开展的3期MAJESTY研究已达到主要终点。研究结果显示，与活性对照相比，接受Gazyva/Gazyvaro（obinutuzumab）治疗的患者在两年（104周）时实现完全缓解的人数显著更多，差异具有统计学意义且具临床意义。辉瑞小分子结直肠癌3期结果积极，将递交监管申请辉瑞（Pfizer）近日宣布，其关键性3期BREAKWATER研究中队列3取得积极顶线结果。该队列评估了Braftovi（encorafenib）与西妥昔单抗（商品名Erbitux）和mFOLFOX6治疗方案（包括氟尿嘧啶、亚叶酸钙和奥沙利铂）构成的组合疗法，用于既往未经治疗、携带BRAF V600E突变的转移性结直肠癌（mCRC）患者的疗效。百利天恒：自研ADC药物注射用BL-M11D1获批临床 3月4日，百利天恒（688506）发布公告，公司自主研发的创新生物药注射用BL-M11D1（CD33-ADC）的药物临床试验获得批准。BL-M11D1是与iza-bren出自同一技术平台、与iza-bren共享同一“连接子+毒素”平台的靶向CD33的ADC药物。珍宝岛药业拓展神经系统疾病产品管线，布瑞哌唑系列品种获批上市 3月11日，珍宝岛药业发布公告，子公司哈珍宝公司及鸡西分公司分别获得布瑞哌唑片及布瑞哌唑化学原料药的上市许可。这一成果标志着企业在抗精神病药物领域的布局迈出了关键一步，进一步丰富产品管线，提升了企业在神经系统疾病治疗领域的综合竞争力。全球唯一!康方生物三抗获批临床康方生物自主研发的注射用AK150正式获批临床，适应症为晚期实体瘤。根据公开信息，这是目前全球范围内唯一一款同时靶向LILRB1/LILRB2/CSF1R的在研三抗产品。正大天晴复方制剂1类新药获批临床正大天晴宣布其1类创新药TQB6457注射液在中国获批临床，用于治疗晚期恶性肿瘤。这是一款CCR8单克隆抗体与PD-1抗体组成的固定复方制剂，旨在通过探索以单一制剂代替联合用药，提升晚期肿瘤患者的用药依从性，打破用药限制。

2026-03-31

·利穗LISURE

拾穗 | 三月生物制药行业要闻

重要新闻 IMPORTANT NEWS 01 1. 11.8亿美元！德琪医药CD19/CD3双抗授权优时比 3月4日，德琪医药宣布与优时比达成全球独家授权协议，授予后者在全球范围内推进CD19/CD3双特异性T细胞连接抗体ATG-201的开发、生产及商业化的独家权益，并包括与ATG-201相关的生产技术授权。（点击阅读原文▶11.8亿美元！德琪医药CD19/CD3双抗授权优时比） 2. 超15亿美元！赛诺菲引进正大天晴FIC新药全球权益 2026年3月4日，中国生物制药宣布，其附属公司正大天晴药业已与 Sanofi S.A.的一间全资附属公司（Sanofi）就JAK/ROCK抑制剂罗伐昔替尼在全球的开发、生产及商业化订立独家授权协议。（点击阅读原文▶超15亿美元！赛诺菲引进正大天晴FIC新药全球权益） 3. 3.28 亿美元！元羿生物引进一款潜在 first-in-class 新药 3 月 9 日，元羿生物与 Rapport Therapeutics 宣布达成一项独家许可协议，元羿生物获得在大中华区开发和商业化后者的 RAP-219 的独家权利，交易总额高达 3.28 亿美元。（点击阅读原文▶3.28 亿美元！元羿生物引进一款潜在 first-in-class 新药） 4. 超 3.4 亿元！云顶新耀收购箕星药业一款产品 3 月 23 日，云顶新耀宣布与箕星药业达成资产收购协议，获得艾曲帕米（Etripamil）鼻喷雾剂（拟定中文商品名：星必妥®）在大中华区的开发、商业化及产品地产化权益，本次合作总金额不超过 5000 万美元（约合 3.4 亿元）。（点击阅读原文▶超 3.4 亿元！云顶新耀收购箕星药业一款产品） 5. 百亿合约落地！派格生物×腾瑞制药，GLP-1商业化迎来重磅里程碑 3月16日，派格生物（02565）发布重磅公告，与上海腾瑞制药达成核心产品派达康®️在中国大陆地区的独家商业化战略合作。这不仅是国内GLP-1赛道一次标志性的商业化联手，更直接为派格生物锁定了累计销售规模超百亿元的长期目标，同时带来1.4亿港币权益金的确定性现金流入。（点击阅读原文▶百亿合约落地！派格生物×腾瑞制药，GLP-1商业化迎来重磅里程碑）研究进展 RESEARCH PROGRESS 02 1. 国产首个！君实生物PD-1皮下制剂申报上市 3月9日，CDE网站显示，君实生物的PD-1皮下制剂特瑞普利单抗注射液（皮下注射）申报上市。（点击阅读原文▶国产首个！君实生物PD-1皮下制剂申报上市) 2. 首创！康方生物三抗新药AK150（ILT2/ILT4/CSF1R）进入临床 3月9日，CDE 官网显示，康方生物注射用 AK150 获批临床，用于治疗晚期恶性实体瘤。（点击阅读原文▶首创！康方生物三抗新药AK150（ILT2/ILT4/CSF1R）进入临床) 3.又一双抗 ADC 首次启动 III 期临床，来自康宁杰瑞近日，药物临床试验登记与信息公示平台官网显示，康宁杰瑞登记了一项 JSKN016 对比研究者选择的治疗用于标准治疗失败的三阴性乳腺癌的 III 期研究。根据公开信息，这是 JSKN016 启动的首个 III 期。（点击阅读原文▶又一双抗 ADC 首次启动 III 期临床，来自康宁杰瑞) 4. 正大天晴 1 类新药 III 期成功 3 月 12 日，中国生物制药发布公告，其附属公司正大天晴自主研发的国家 1 类创新药 TQB3454（IDH1 抑制剂）治疗伴 IDH1 突变晚期胆道癌 III 期临床研究已完成方案预设的期中分析，独立数据监查委员会（IDMC) 判定主要研究终点无进展生存期 (PFS)、总生存期 (OS) 均达到方案预设的优效界值。（点击阅读原文▶正大天晴 1 类新药 III 期成功) 5. 恒瑞两款 1 类新药申报上市 3 月 14 日，CDE 官网显示，恒瑞有两款 1 类新药上市申请获得受理，分别为舒地胰岛素诺利糖肽注射液、富马酸立康可泮胶囊。（点击阅读原文▶恒瑞两款 1 类新药申报上市) 6. 齐鲁首个阿尔茨海默病 1 类新药启动临床 23 月 17 日，药物临床试验登记与信息公示平台官网显示，齐鲁制药登记了一项评价 QLH2405 注射液在健康及阿尔茨海默病源性轻度认知障碍和轻度阿尔茨海默病参与者中单次、皮下注射、剂量递增的安全性、耐受性、药代动力学及药效学的随机、双盲、安慰剂对照 Ⅰ 期临床研究。（点击阅读原文▶齐鲁首个阿尔茨海默病 1 类新药启动临床） 7. 三生制药新一代长效贫血新药获批上市 3 月 19 日，药监局批准三生制药申报的罗赛促红素 α 注射液（商品名：新比澳）上市，该品种用于治疗因慢性肾脏病引起的贫血，且正在接受促红细胞生成素治疗的血液透析患者。（点击阅读原文▶三生制药新一代长效贫血新药获批上市） 8. 全球首创！信达生物长效眼科新药 III 期成功，拟报上市 3 月 24 日，信达生物宣布，其依莫芙普-α 注射液（IBI302）在中国新生血管性年龄相关性黄斑变性（nAMD）人群中开展的 III 期临床研究（STAR，登记号：NCT05972473）达成 52 周主要终点。（点击阅读原文▶全球首创！信达生物长效眼科新药 III 期成功，拟报上市） 9. 甘李药企启动长效 GLP-1 新 III 期临床 3 月 24 日，药物临床试验登记与信息公示平台官网显示，甘李药业登记了一项在不使用气道正压通气治疗的肥胖的中度至重度阻塞性睡眠呼吸暂停受试者中评价 GZR18（博凡格鲁肽）注射液疗效与安全性的多中心、随机、双盲、平行、安慰剂对照的 Ⅲ 期临床研究（登记号：CTR20261125）。（点击阅读原文▶甘李药企启动长效 GLP-1 新 III 期临床） 10. 全球首个！国产「重组人白蛋白」申报上市，已在俄罗斯获批 3 月 25 日，CDE 官网显示，安睿特递交的重组人白蛋白注射液上市申请获得受理。根据该药的临床研究进度，Insight 数据库推测本次申报的适应症为肝硬化腹水患者低白蛋白血症。此前，该产品已在俄罗斯获批上市，是全球首个上市销售的重组人白蛋白注射液产品。（点击阅读原文▶全球首个！国产「重组人白蛋白」申报上市，已在俄罗斯获批）行业资讯 INDUSTRY INFORMATION 03 1. 中国ADC全球开花结果在行业里仍在思考“接棒创新药BD的新看点会是什么”时，中国创新药BD交易再次掀起新浪潮。医药魔方NextPharma数据库显示，2026年开年至今中国创新药领域已完成44起对外BD合作，总金额突破567亿美元，相较于2025年同期的244亿美元，增长超132%。（点击阅读原文▶中国ADC全球开花结果） 2. 合成生物学，从内卷到突围 2026年初春，合成生物学上市公司业绩预告陆续披露，一张张成绩单摆在投资人面前，有人欢喜有人忧。有的企业依旧在快车道上疾驰，有的却陷入了增长泥潭。华熙生物、华恒生物、凯赛生物、嘉必优等一众耳熟能详的公司登陆二级市场，此时的A股尚处于概念炒作阶段，相关上市公司股价水涨船高，合成生物学一下子在投资圈里火了起来，很多制药公司都搭建新团队，开始转型合成生物学业务。（点击阅读原文▶合成生物学，从内卷到突围） 3. 中国领衔全球多抗风潮当创新药行业的视野还在四处寻找具备差异化优势新标的时，抗体领域作为“经典”主赛道已悄然发生了大变化：更多的钱、更多的临床突破、更多的注意力涌入其中。（点击阅读原文▶中国领衔全球多抗风潮） 4. 迎接TCE下一波浪潮双抗方兴未艾之际，TCE已经卷到了四抗。日前，复宏汉霖宣布其自主研发的四抗HLX3901的IND申请获NMPA批准，拟用于晚期或转移性实体瘤治疗。HLX3901采用DLL3/DLL3/CD3/CD28组合，通过多靶点协同与共刺激信号策略，在临床前模型中显示出对低表达靶点更优的细胞毒性，治疗窗口较宽。（点击阅读原文▶迎接TCE下一波浪潮） 5. Science：CAR-T之后，CAR-A问世近期，科学家们在阿尔茨海默病（AD）治疗方面连获突破。与3月4日中国科学家在Cell杂志首次发表新型靶向蛋白降解技术SPYTAC相隔一天，来自华盛顿大学医学院的一个研究团队在Science发表了首创疗法——CAR-A，单次注射在小鼠中取得了良好的治疗效果。（点击阅读原文▶Science：CAR-T之后，CAR-A问世） 6. Nature子刊：实体瘤治疗新技术——TrME 3月13日，山东大学药学院姜新义教授团队联合合作伙伴在Nature Biotechnology在线发表题为“A logic-gated trispecific engager enhances macrophage killing of cancer cells in solid tumors”的研究论文。该研究开发了一种逻辑门控三特异性巨噬细胞衔接器（trispecific macrophage engager，TrME），可实现比例性促/抑吞噬信号整合，显著增强巨噬细胞杀瘤能力。（点击阅读原文▶Nature子刊：实体瘤治疗新技术——TrME） 7. Nature：癌症新靶点趋势分析新靶点的发现，往往能催生出极具临床价值与市场潜力的抗癌药物品类。以PD-1/PD-L1通路为例，其first-in-class药物帕博利珠单抗于2014年获批上市，2024年该类药物全球总销售额已达550亿美元，占整个肿瘤市场规模的近五分之一。（点击阅读原文▶Nature：癌症新靶点趋势分析） 8. 新一代百亿抗凝大药将至在全球畅销药榜单上，抗凝药是一类特殊的存在。它不依赖突发疫情，不依附短期风口，却凭借刚性临床需求，长期稳居全球医药市场的核心位置。2025年，阿哌沙班以144亿美元的全球销售额位列全球第六，成为当之无愧的“抗凝之王”。（点击阅读原文▶新一代百亿抗凝大药将至） 9. 千亿抗衰赛道，谁能吃上螃蟹？近年来，随着生命科学在细胞衰老机制、基因调控等基础研究上取得关键突破，一系列以延缓甚至逆转衰老过程为目标的药物或干预手段，正从实验室走向临床前沿。当前，全球抗衰药物市场规模已超 520 亿美元，预计未来十年将持续高速增长。（点击阅读原文▶千亿抗衰赛道，谁能吃上螃蟹？） 10. 网红抗衰“神药”外泌体，离商业化还有多远？外泌体的商业故事始于一个极具想象力的科学概念：作为细胞间通讯的“快递员”快递员，这些直径仅30-150纳米的囊泡携带蛋白质、RNA等生物活性物质，理论上能够向衰老细胞传递“年轻信号”。这为再生医学提供了一个无需细胞移植的解决方案——既规避了干细胞的免疫排斥风险，又能实现靶向修复。（点击阅读原文▶网红抗衰“神药”外泌体，离商业化还有多远？

2026-03-27

·PRNewswire

Akeso Reports Full-Year 2025 Financial Results

HONG KONG, March 26, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced its 2025 annual results, highlighting a year of comprehensive, strategic leaps across all facets of its business. Commercial Operations Enter a New Phase of Growth In 2025, Akeso achieved record commercial sales revenue of RMB3,033.1 million, a 51.48% year-on-year increase. All approved products and indications are now included in China's National Reimbursement Drug List (NRDL). The strong commercial growth in 2025 was fueled by strong clinical validation and widespread adoption by both healthcare professionals and patients. By the end of 2025, several high-impact indications were added to the latest NRDL, including: Ivonescimab: 1L PD-L1(+) NSCLC Cadonilimab: 1L gastric cancer and 1L cervical cancer Other products: Multiple indications for penpulimab, ebdarokimab and ebronucimab With stable pricing for core first-line (1L) indications and improved hospital access, Akeso's commercial platform is positioned for a transformative 2026. Advanced Clinical Development of IO 2.0 Bispecifics Ivonescimab (PD-1/VEGF): As the world's first and only approved PD-1/VEGF bispecific antibody, ivonescimab solidified its global leadership in 2025 by iterating upon existing Standards of Care (SOC) to reshape the oncology landscape. Ivonescimab has benefited approximately 70,000 patients to date. Ivonescimab's IO 2.0 value is anchored by a series of landmark Phase III victories: in the HARMONi-2 study, ivonescimab achieved a head-to-head win against pembrolizumab in 1L PD-L1(+) NSCLC, establishing a new "chemo-free" standard. Additionally, the HARMONi-A study marked it as the first immunotherapy to reach dual PFS and OS positivity in EGFR-TKI resistant NSCLC, while HARMONi-6 demonstrated its superiority over tislelizumab (anti-PD-1 monoclonal antibody) in combination with chemotherapy in 1L squamous NSCLC, successfully overcoming traditional anti-VEGF contraindications for squamous histology. Currently, the U.S. FDA has accepted the BLA from our partner Summit Therapeutics for ivonescimab plus chemotherapy in nsq-NSCLC following third-generation EGFR-TKI failure. As the only commercialized PD-1/VEGF bispecific globally, ivonescimab has secured two approved lung cancer indications in China (both NRDL-listed) with another sNDA under review for the first-line treatment of advanced squamous NSCLC. The Company's expansive global development program now encompasses 15 Phase III trials, including 5 global studies and 7 head-to-head studies against PD-1/L1 therapies, targeting critical 1L indications, IO-resistant, and "cold" tumors. Cadonilimab (PD-1/CTLA-4): Cadonilimab (PD-1/CTLA-4) is the world's first and only approved bispecific antibody of its class. With approximately 120,000 patients treated to date, it has demonstrated "all-comer" clinical benefits across multiple tumor types. Its exceptional efficacy in treating challenging cases, such as IO-resistant and "cold" tumors, has solidified its status as a cornerstone therapy in the IO 2.0 era. Akeso is advancing 12 registrational or Phase III clinical trials for cadonilimab globally, covering more than 10 major cancer types and spanning the full treatment lifecycle and clinical scenarios. Furthermore, the Company is spearheading two international registrational studies: a head-to-head Phase III trial against nivolumab in first line gastric cancer, and a registrational trial for IO-resistant hepatocellular carcinoma (HCC). These high-efficiency global studies aim to address significant unmet medical needs, further unlocking cadonilimab's global therapeutic value. Oncology Therapy Matrix Continues to Expand Akeso is pioneering the IO 2.0 + ADC 2.0 strategy, expanding its portfolio from bispecifics into trispecifics and TCE platforms. the Company is fast-tracking the global development of its next-gen ADCs, such as the bispecific Trop2/Nectin4 AK146D1, and the HER3 AK138D1. By combining these with its core IO assets (cadonilimab and ivonescimab), Akeso aims to address the narrow therapeutic windows associated with traditional ADCs. With AK150 (trispecific) now in the clinic and more trispecific/multispecific antibodies and TCE bispecific/multispecific antibodies approaching clinical entry, Akeso is rapidly building a formidable, next-generation oncology matrix. Paradigm Shift in Bispecific Excellence: Continuous Expansion of the Oncology Portfolio Akeso is methodically extending its IO 2.0 leadership into the emerging ADC 2.0 landscape, thereby operationalizing its integrated "IO 2.0 + ADC 2.0" platform thesis while systematically advancing bispecific antibody expertise into higher order trispecific/multispecific antibodies and TCE platforms. In the area of IO, Akeso remains the sole global player with two approved immuno-oncology bispecifics, a distinction that confers both first-mover clinical validation and a proprietary data moat in dual-check point/dual-pathway blockade. On the ADC front, the Company's next-generation candidates, notably bispecific ADC AK146D1 and novel ADC AK138D1, are purpose-engineered to overcome the narrow therapeutic window that chronically plagues current ADCs, advancing the field into ADC 2.0. Phase II trials combining these proprietary ADCs with cadonilimab and ivonescimab are now underway, with global expansion planned. Both IO bispecifics are also being explored broadly with external high-potential ADCs. Meanwhile, the Company's first trispecific antibody, AK150, is in clinical development, with more trispecific/multispecific and TCE assets approaching the clinic. Immune and CNS Diseases Enter the Dual-Target Era Beyond building global competitiveness in oncology, Akeso has created a powerful new growth engine in immune-related diseases. Leveraging its bispecific and multispecific antibody platforms, the Company is advancing a pipeline of novel candidates in autoimmune, respiratory, allergy, and CNS indications, including AK139, AK152 (siRNA), KF111 (siRNA), and KF115 (siRNA), alongside commercial-stage products like ebdarokimab, gumokimab and manfidokimab. This layered portfolio is rapidly strengthening Akeso's global presence beyond oncology. AI-Powered R&D and Cutting-Edge Platforms Building atop its globally competitive command in monoclonal and bispecific antibody development, Akeso has executed a deliberate expansion into frontier therapeutic modalities by embedding AI end-to-end across the entire R&D and manufacturing continuum - from discovery and cell-line/process development through to smart manufacturing. The outcome is a tightly orchestrated portfolio of differentiated platforms: the Tetrabody antibody technology platform, the AI-powered drug R&D platform, the Dual-Shield ADC technology platform, the Dual-Lock T-cell engager (TCE) technology platform, the Tissue-Smart siRNA/mRNA technology platform, and the cell therapy technology platform. These assets collectively solidifies Akeso's global innovation edge, unlocking 0-to-N breakthroughs across multiple high-barrier domains where conventional therapeutic modalities have historically stalled. Akeso continues to iterate and scale its AI-powered, integrated drug discovery platform, which now provides comprehensive coverage across the entire R&D lifecycle for both antibody and nucleic acid therapeutics, while extending into additional frontier modalities. At its core lies a proprietary AI technology matrix that fuses high-precision structure prediction, immunogenicity prediction, fully automated humanization, and one-step sequence optimization. This closed-loop, data-rich architecture enables end-to-end precise engineering from sequence design to clinical development, significantly accelerating the efficient and high throughput development of innovative therapies. Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, commented: "2025 marked a definitive strategic leap for Akeso across commercialization, global clinical expansion, and our broadening multi-platform innovation ecosystem. We achieved over 50% sales revenue growth. This success provides a powerful springboard for continued commercial and clinical execution in 2026. We are now pioneering a shift in therapeutic paradigms. Leveraging our leadership in IO bispecifics, we are expanding into 'IO 2.0 + ADC 2.0,' including bispecific ADCs, trispecifics, and TCE platforms. Beyond oncology, we are bringing the immense therapeutic benefit of bispecific antibodies to immunology, respiratory, and CNS diseases, all powered by our integrated AI discovery engine. Our vision to bring transformative and life saving medicine to every patient on Earth is coming to fruition. With over ten products in international trials, including studies that includes ivonescimab and cadonilimab, we are advancing our mission to deliver world-class medicines to patients worldwide. By integrating global talent, capital, and R&D resources, and integrating AI into our research and development efforts, we are building a robust institutional framework to sustain Akeso's long-term leadership in innovation in the global biopharmaceutical industry." About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. Forward-Looking Statements This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

临床3期上市批准免疫疗法临床2期财报

100 项与木聚硫钠相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D05428	木聚硫钠	C05BA04 G04BX15	DBSALT000991

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
间质性膀胱炎	美国	Janssen Pharmaceuticals, Inc.	1996-09-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
膝关节炎	临床3期	欧盟	Paradigm Biopharmaceuticals Ltd.	2022-03-18
骨关节炎	临床3期	澳大利亚	Paradigm Biopharmaceuticals Ltd.	2022-01-30
膀胱炎	临床3期	中国台湾	泰宗生物科技股份有限公司	2020-10-14
泌尿道感染	临床3期	中国台湾	泰宗生物科技股份有限公司	2020-10-14
黏多糖贮积症I型	临床2期	澳大利亚	Paradigm Biopharmaceuticals Ltd.	2022-01-30
黏多糖贮积症VI型	临床2期	澳大利亚	Paradigm Biopharmaceuticals Ltd.	2022-01-30
过敏性鼻炎	临床2期	澳大利亚	Paradigm Biopharmaceuticals Ltd.	2022-01-30
罗斯河热	临床2期	澳大利亚	Paradigm Biopharmaceuticals Ltd.	2022-01-30
季节性过敏性鼻炎	临床2期	瑞典	Paradigm Biopharmaceuticals Ltd.	2016-11-14
慢性前列腺炎	临床2期	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	2005-10-12

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


2021 ARVO Annual Meeting (ARVO2021)	N/A	黄斑变性	-	Pentosan Polysulfate	壓觸願糧選鑰壓夢蓋壓(餘夢艱鹽蓋範鏇鹹鬱窪) = 齋製選壓蓋製膚壓糧廠糧選鬱顧獵簾選憲廠夢 (製憲夢齋鏇襯範壓鏇壓, 238 ~ 290) 更多	不佳	2021-06-01
NCT02930005 (CTgov)	临床2期	躁郁症 \| 躁郁症1型 \| 分裂情感性障碍 ... 更多	8	Meclofenamic acid (Meclofenamic Acid)	鑰鏇鏇艱選鏇衊廠願膚 = 鹹鏇憲鬱壓選齋鏇醖築願壓獵窪齋餘夢廠蓋顧 (淵範鏇選顧鑰觸簾醖範, 衊壓築蓋選構廠齋範鏇 ~ 餘襯積夢夢簾鹽襯淵夢) 更多	-	2019-03-26
NCT02930005 (CTgov)	临床2期	躁郁症 \| 躁郁症1型 \| 分裂情感性障碍 ... 更多	8	Pentosan polysulfate sodium (Pentosan Polysulfate Sodium)	鑰鏇鏇艱選鏇衊廠願膚 = 獵鬱醖鹹蓋鹹壓願膚醖願壓獵窪齋餘夢廠蓋顧 (淵範鏇選顧鑰觸簾醖範, 觸積衊顧鑰餘觸憲製構 ~ 衊網製淵醖艱網糧衊壓) 更多	-	2019-03-26
NCT00086684 (CTgov)	临床4期	间质性膀胱炎	369	Placebo	憲齋膚願顧糧遞製淵醖 = 艱壓蓋糧構願遞鏇鹽憲網鏇憲夢構獵淵範觸蓋 (遞遞餘獵繭淵壓夢遞選, 鬱廠餘鏇糧網齋觸廠壓 ~ 糧獵鑰願膚積鹽鑰鑰襯) 更多	-	2012-07-06