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更新于：2025-05-19
MORF-057
更新于：2025-05-19
概要
基本信息
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
6
项与 MORF-057 相关的临床试验NCT06964776
A Phase 1 Study to Further Investigate the Pharmacokinetics, Safety and Tolerability, Food Effect and Drug-Drug Interaction of LY4268989 (MORF-057) in Healthy Participants
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants
开始日期2025-05-01 |
申办/合作机构 |
CTIS2023-508158-24-00
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Crohn’s Disease (GARNET) - MORF-057-203
开始日期2024-06-26 |
申办/合作机构 |
NCT06226883
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
开始日期2024-04-04 |
申办/合作机构 |
100 项与 MORF-057 相关的临床结果
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100 项与 MORF-057 相关的转化医学
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100 项与 MORF-057 相关的专利（医药）
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1
项与 MORF-057 相关的文献（医药）CURRENT OPINION IN GASTROENTEROLOGY
Gut-directed therapeutics in inflammatory bowel disease
Article
作者: Ciorba, Matthew A. ; Curiel, David T. ; Kratschmer, Christina
Purpose of review:
Tissue-directed therapies (TDTs) provide potential advantages, including improved tolerance, safety, and efficacy. This review provides a conceptual framework for understanding intestinal TDT and summarizes the current landscape of TDT in inflammatory bowel disease (IBD).
Recent findings:
Vedolizumab, a mAb targeting the gut homing α4β7 integrin, served as revolutionary proof-of-principle for the power of advanced TDT in IBD. The development of other monoclonal antibodies targeting cell adhesion molecules followed including abrilumab (α4β7), etrolizumab (β7), and ontamalimab (MAdCAM-1). MORF-057, an oral small molecule inhibitor of α4β7, is now in development for ulcerative colitis. Efforts have also been made toward gut specific JAK inhibitors. Microbiome-based therapies, including engineered probiotics, bacteriophages, and postbiotics, are gaining interest. There are also a number of innovative drug delivery methods, including engineered yeast, hydrogels, and nanoparticles, and viral-based gene therapy.
Summary:
Gut-targeted therapies range from novel variations on traditional drugs (i.e., mAbs and small molecules) to microbiome-based therapeutics and engineered delivery systems. They can be used alone or in combination with currently available therapies. Future directions should focus on the development of tried-and-true modalities (mAbs, small molecules) as well as the microbiome and more innovative delivery systems.
93
项与 MORF-057 相关的新闻（医药）2025-05-13
·药事纵横
32 亿美元收购的 “潜力股”2025年5月，礼来宣布启动口服抗炎新药LY4268989的中国I期临床，这款斥资32亿美元收购的小分子药物，直指百亿炎症性肠病（IBD）市场。作为α4β7整合素抑制剂，LY4268989通过阻断免疫细胞攻击肠道，有望革新溃疡性结肠炎、克罗恩病治疗模式。面对武田维得利珠单抗62.87亿美元的销售神话，礼来以口服剂型切入，试图改写“注射为王”的现状。炎症性肠病（IBD）主要包括溃疡性结肠炎（UC）和克罗恩病（CD），是一类慢性、复发性的肠道炎症疾病，严重影响患者生活质量。传统治疗药物如氨基水杨酸制剂、糖皮质激素、免疫抑制剂等，虽在一定程度上缓解症状，但存在疗效局限和副作用大等问题。近年来，生物制剂如肿瘤坏死因子 -α（TNF-α）抑制剂、维得利珠单抗等的出现，为 IBD 治疗带来新希望，不过，这些药物多为注射剂型，使用不便，患者依从性较差。因此，开发更有效、便捷的治疗药物成为 IBD 领域的迫切需求。LY4268989 作用机制独特，它通过抑制 α4β7 整合素，有效阻断免疫细胞表面的 α4β7 整合素与粘膜内皮细胞配体 MAdCAM - 1 的相互作用，从而阻止淋巴细胞从血流进入肠粘膜组织，减少炎症细胞浸润，降低肠道炎症反应，为 IBD 治疗提供全新途径。在适应症布局上，LY4268989 覆盖溃疡性结肠炎和克罗恩病两大主要 IBD 类型。目前，Morphic Therapeutic 已开展两项针对溃疡性结肠炎的 II 期临床研究，以及一项针对克罗恩病的 II 期临床研究。2023 年 4 月公布的MORF-057（100mg，每日 2 次）治疗中重度 UC 的 II 期 EMERALD-1研究（n = 35）结果显示，患者接受治疗 12 周后，Robarts 组织病理学指数（RHI）评分显著下降（-6.4 分，P = 0.002）；25.7%患者达到临床缓解（通过改良版 Mayo 评分（mMCS）评估），45.7% 患者达到临床应答 ，展现出良好的治疗前景。值得注意的是，在 IBD 治疗领域，武田的维得利珠单抗一直占据重要地位。作为全球唯一一款上市的同靶点单抗药物，维得利珠单抗自 2014 年首次在美国获批上市，2020 年在中国获批上市后，销售额一路攀升，2024 年全球销售额达到 62.87 亿美元，稳稳占据全球药品销售额 TOP100 榜单一席之地。然而，维得利珠单抗为注射剂型，患者需定期前往医疗机构接受注射，使用不便。LY4268989 的口服优势使其在提升患者依从性方面具有天然优势，有望打破现有市场格局，成为维得利珠单抗强有力的挑战者。中国 I 期临床启动2025 年 5 月 9 日，ClinicalTrials.gov官网的一则登记信息，标志着LY4268989 在中国和日本受试者中的 I 期临床研究正式拉开帷幕。这一研究计划纳入 66 名受试者，采用随机、平行分配的试验设计，包含 5 个队列，其中队列 1、4、5 为双盲，队列 2 和 3 为开放标签 ，研究计划于2025 年 5 月开始，7 月完成，进度之快备受关注。该研究内容丰富，涵盖多个关键方面。在药代动力学评估上，将通过测定不同时间点血药浓度，获取药物吸收、分布、代谢和排泄等过程相关参数，了解药物在体内动态变化规律，为后续剂量确定和给药方案制定提供科学依据。例如，通过测定最大浓度（Cmax）和血药浓度 - 时间曲线下面积（AUC），评估药物吸收程度和速度。在食物效应研究方面，探究进食对药物吸收、代谢等过程的影响，确定最佳服药时间和饮食注意事项，提高药物疗效和安全性。药物相互作用研究则关注 LY4268989 与其他常用药物同时使用时的相互影响，避免不良反应，保障患者用药安全。安全性是此次 I 期临床研究的重中之重，研究将密切监测治疗期间出现的不良事件和严重不良事件，为后续 II 期临床研究的开展奠定坚实基础。通过全面、严谨的 I 期临床研究，有望深入了解 LY4268989 在人体的安全性和药效学特征，为其全球同步开发铺平道路，推动其在IBD 治疗领域的应用进程。百亿市场争夺战在 IBD 治疗药物市场中，武田的维得利珠单抗堪称 “霸主”。自上市以来，维得利珠单抗凭借其针对 α4β7 整合素靶点的精准治疗，在 IBD 治疗领域迅速崛起。2024 年，其全球销售额高达 62.87 亿美元 ，稳稳跻身全球药品销售额 TOP100 榜单，成为武田制药的重要营收支柱，也充分证明其在 IBD 治疗市场的广泛认可和巨大需求。维得利珠单抗作为一款静脉注射的人源化单克隆抗体，需在医疗机构由专业医护人员进行给药，第0 周、第 2 周、第 6 周为诱导治疗阶段，随后每 8 周给药 1 次维持治疗。尽管疗效显著，但频繁前往医院注射的治疗方式，给患者生活带来诸多不便，影响患者依从性。相比之下，LY4268989 作为口服剂型，具有独特优势。患者可自行在家服药，无需频繁前往医院，大大提高治疗便利性，尤其适合工作繁忙或行动不便患者，能显著提升患者依从性，使患者更易坚持长期治疗。良好的依从性对于 IBD 这种慢性疾病的治疗至关重要，有助于提高治疗效果，减少疾病复发风险。从市场前景看，中国 IBD 患者数量增长迅速，IBD 发病率呈上升趋势，对有效治疗药物需求日益增长。LY4268989 在中国启动 I 期临床研究，加速在中国市场的开发进程，有望满足中国 IBD 患者未被满足的治疗需求。若其在后续临床试验中展现出良好疗效和安全性，将为中国 IBD 患者提供新治疗选择，推动中国 IBD 治疗标准革新，改变现有治疗格局。在全球 IBD 治疗市场竞争激烈的当下，LY4268989 凭借口服剂型优势和独特作用机制，有望在百亿 IBD 市场中抢占一席之地，挑战维得利珠单抗的霸主地位，为广大 IBD 患者带来新希望，推动 IBD 治疗领域不断向前发展。药事纵横投稿须知：稿费已上调，欢迎投稿
并购临床1期临床2期上市批准申请上市
2025-04-23
·药明康德
根据各大药企在2024年的营收，行业媒体Fierce Pharma于近日公布了全球前20大药企排名。在这份名单中，强生（Johnson & Johnson）、罗氏（Roche）、默沙东（MSD）位居前三。本文将为各位读者朋友们整理这些药企在近期取得的进展。药明康德团队根据公开资料制图（在此排名中，排除各家公司在健康科学领域之外的收入，美元换算是基于年度平均汇率进行）强生2024年营收：888亿美元近期，强生公司取得了多项重要监管进展。今年3月，美国FDA批准了其抗IL-23抗体Tremfya用于治疗中度至重度活动性克罗恩病成人患者。根据新闻稿，Tremfya是首个同时提供皮下注射和静脉注射诱导治疗方案以治疗此类患者的IL-23抑制剂。此外，今年1月，强生的Spravato鼻喷雾剂获FDA批准，用于治疗难治性抑郁症（TRD）成人患者，成为首款获批作为单药疗法、用于对至少两种口服抗抑郁药应答不佳的成人重度抑郁症（MDD）患者的药物。在欧洲，强生也取得了重要突破。其双抗疗法Rybrevant联合Lazcluze获得欧盟委员会批准一线治疗携带EGFR第19号外显子缺失（ex19del）或第21号外显子L858R突变的晚期非小细胞肺癌（NSCLC）成年患者。罗氏2024年营收：653亿美元罗氏近年来通过产品创新和战略收购持续强化其治疗管线。其双特异性抗体Vabysmo在2022年获批后，又于2024年7月获FDA批准单剂量预填充注射器剂型，显著提升了用药便利性。在免疫疗法领域，罗氏2024年以15亿美元收购Poseida Therapeutics，获得其异体细胞疗法平台和基因编辑工具，为开发潜在"first-in-class"疗法奠定基础。同时，其双特异性抗体Columvi和Lunsumio分别在中美两国取得重要监管进展，前者联合吉西他滨和奥沙利铂用以治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）患者的补充生物制品许可申请（sBLA）已被美国FDA受理，有望在今年获批；后者已于2024年年末获得中国国家药监局（NMPA）批准上市，治疗复发或难治性滤泡性淋巴瘤（FL）成人患者。默沙东2024年营收：642亿美元默沙东公司正通过战略性收购和管线布局规划未来发展方向，其中代表性的交易包括：2021年以115亿美元收购Acceleron Pharma，获得肺动脉高压创新疗法sotatercept（该药物已于2023年3月获FDA批准，有望成为该领域的基石性疗法）；2023年以108亿美元收购Prometheus Biosciences，补充了溃疡性结肠炎、克罗恩病等自身免疫疾病管线；以及2023年达成的总额30亿美元的EyeBiotech收购协议，拓展眼科治疗领域。默沙东公司高管在近期电话会议中表示，公司正持续关注各类研发和商业合作机会，以确保持续的创新能力和造福患者。辉瑞2024年营收：636亿美元辉瑞在2024年持续推动新产品上市并加强战略布局。在肿瘤领域，BRAF抑制剂Braftovi组合治疗方案获FDA加速批准用于BRAF V600E突变转移性结直肠癌，成为该适应症首个获批的包含BRAF靶向疗法的组合疗法；血友病领域则取得双重突破，皮下注射疗法Hympavzi获FDA批准，一次性基因疗法Durveqtix获得欧盟有条件上市许可。辉瑞同时积极拓展研发合作网络：9月与Flagship Pioneering合作开展心血管和肾脏疾病领域研究项目；11月又与Flagship旗下公司合作开发肥胖症和NSCLC新靶向疗法；在自身免疫疾病领域，通过辉瑞Ignite与Acepodia合作开发创新细胞疗法。艾伯维2024年营收：563亿美元艾伯维成功构建了多元化产品矩阵：免疫学领域，IL-23抑制剂Skyrizi于2024年6月获批溃疡性结肠炎适应症，与JAK抑制剂Rinvoq形成炎症性肠病全谱系覆盖；肿瘤治疗取得突破性进展，抗体偶联药物（ADC）Elahere获美国FDA完全批准，与Genmab合作开发的Epkinly获得美国FDA加速批准，成为获FDA批准用以治疗复发或难治性滤泡性淋巴瘤成人患者的首个皮下注射T细胞接合双特异性抗体；抗感染领域方面，其与辉瑞合作开发的Emblaveo已获欧盟和美国FDA批准治疗多重耐药革兰氏阴性菌感染；该公司同时在神经退行性疾病管线新增帕金森病疗法Vyalev。为强化研发管线，艾伯维2024年开展了系列战略收购：收购Nimble Therapeutics获得口服肽类IL-23R抑制剂及肽类药物开发平台，整合Aliada Therapeutics的ALIA-1758布局阿尔茨海默病赛道，囊获Celsius Therapeutics的TREM1靶向抗体完善炎症性疾病矩阵，收购Landos Biopharma并获得其NLRX1激动剂强化炎症性肠病管线。通过"自主开发+战略收购"双重策略，艾伯维系统构建覆盖免疫、肿瘤、抗感染及神经退行性疾病的创新产品组合，为其可持续增长奠定基础。阿斯利康2024年营收：541亿美元2024年，阿斯利康在肿瘤和罕见病领域取得多项重要进展。其重磅EGFR抑制剂Tagrisso获得美国FDA两项新适应症批准：一是联合化疗治疗局部晚期或转移性EGFR突变NSCLC成人患者；二是用于治疗放化疗后不可切除的III期EGFR突变NSCLC患者。2025年1月，该公司与第一三共（Daiichi Sankyo）联合开发的ADC疗法Datroway获FDA批准上市，用于HR阳性/HER2阴性乳腺癌治疗；而口服补体因子D抑制剂Voydeya也于2024年4月获批，作为Ultomiris/Soliris的附加疗法用于阵发性睡眠性血红蛋白尿症（PNH）患者的血管外溶血管理。此外，阿斯利康2024年以20亿美元收购Fusion Pharmaceuticals，获得其靶向前列腺特异性膜抗原（PSMA）的锕系放射偶联药物；同年10月又以1亿美元预付款与石药集团达成针对脂蛋白（a）的临床前药物YS2302018的独家许可协议。随着这些战略布局的推进，2025年阿斯利康预计将迎来多个关键临床数据读出。诺华2024年营收：503亿美元2024年，诺华在肿瘤、肾病及放射性配体治疗领域取得多项突破性进展。其CDK4/6抑制剂Kisqali获美国FDA和欧盟委员会批准，联合芳香酶抑制剂用于HR阳性/HER2阴性早期乳腺癌（包括无淋巴结转移的患者）的辅助治疗；费城染色体阳性慢性髓系白血病治疗药物Scemblix则凭借优于标准疗法的3期数据获得FDA加速批准。在肾病领域，补体替代通路因子B抑制剂Fabhalta先后于2024年8月和3月获批治疗IgA肾病和C3肾小球病。此外，放射性配体疗法（RLT）Pluvicto也于2025年3月获FDA批准用于PSMA阳性转移性去势抵抗性前列腺癌（mCRPC）患者。通过战略性收购，诺华持续强化研发管线布局：2024年5月以超17亿美元收购Mariana Oncology拓展放射性配体疗法研发管线；11月以11亿美元收购Kate Therapeutics，布局基因治疗；同年还以29亿美元收购MorphoSys，增强血液肿瘤领域优势。百时美施贵宝2024年营收：483亿美元去年，百时美施贵宝的多款创新疗法获得监管突破与临床应用拓展。在血液肿瘤领域，公司3月获得CD19靶向CAR-T疗法Breyanzi加速批准，用于治疗复发/难治性慢性淋巴细胞白血病和小淋巴细胞淋巴瘤（SLL），并于5月扩展至滤泡性淋巴瘤（FL）和套细胞淋巴瘤（MCL）适应症；PD-1抑制剂Opdivo则在3月获批联合化疗用于尿路上皮癌一线治疗，10月进一步扩展至可切除NSCLC围手术期治疗，其皮下注射剂型Opdivo Qvantig更于年底获批，将给药时间缩短至5分钟。靶向BCMA的CAR-T疗法Abecma则于4月获批用于多发性骨髓瘤，在临床试验中，该疗法将无进展生存期提高至标准疗法的三倍以上；酪氨酸激酶抑制剂（TKI）Augtyro和KRAS G12C抑制剂Krazati分别在6月获加速批准用于实体瘤和结直肠癌治疗；神经精神领域则迎来突破——Cobenfy成为近十年来首个获批治疗精神分裂症的新机制药物。研发合作方面，公司通过战略合作强化管线布局：年初与VantAI合作开发分子胶新靶点，与Immunocore合作探索TCR双特异疗法IMC-F106C联合Opdivo治疗黑色素瘤的疗效和安全性；10月携手Prime Medicine开发下一代T细胞疗法；年底则与BioArcti达成全球许可协议，推进靶向焦谷氨酸修饰β淀粉样蛋白的抗体项目开发。礼来2024年营收：450亿美元2024年，礼来在多个疾病领域实现关键监管突破：5月，RET激酶抑制剂Retevmo获批用于治疗2岁及以上RET基因变异相关实体瘤及甲状腺癌患儿，成为首款覆盖12岁以下RET突变儿童的靶向疗法，6月，该药加速批准转为完全批准用于治疗RET融合阳性甲状腺癌全年龄段患者。7月，靶向β淀粉样蛋白的单抗Kisunla获批治疗早期阿尔茨海默病成人患者；9月，IL-13抑制剂Ebglyss获准用于治疗12岁以上、体重≥40公斤且局部治疗无效的中重度特应性皮炎患者；年底，重磅GLP-1/GIP受体双重激动剂Zepbound获批改善中重度阻塞性睡眠呼吸暂停肥胖患者的呼吸症状。在合作布局上，礼来通过多项战略合作强化管线：2024年初与Isomorphic Labs合作开发基于AlphaFold技术的小分子疗法；7月斥资32亿美元收购Morphic Holding，获得炎症性肠病口服整合素疗法MORF-057；9月与HAYA Therapeutics达成10亿美元的多年协议，利用其RNA引导基因调控平台开发代谢疾病疗法；10月扩展与KeyBioscience的合作，聚焦胰淀素/降钙素双重激动剂（DACRA）在肥胖及相关疾病中的应用。赛诺菲2024年营收：444.6亿美元2024年，赛诺菲与再生元共同开发的重磅抗炎药Dupixent斩获多项关键适应症：年初获FDA批准用于1-11岁嗜酸性粒细胞性食管炎（EoE）儿童患者；年中获美国FDA和欧洲药品管理局批准作为慢性阻塞性肺病（COPD）患者的附加维持治疗，并在随后获FDA批准作为慢性鼻窦炎伴鼻息肉（CRSwNP）青少年患者的辅助维持治疗。此外，IL-6拮抗剂Kevzara获批治疗活动性多关节型幼年特发性关节炎（pJIA）患者，抗CD38抗体Sarclisa则联合VRd方案成为不适合自体干细胞移植的新确诊多发性骨髓瘤成人患者的一线疗法。战略合作方面，赛诺菲1月以17亿美元收购Inhibrx，获得α-1抗胰蛋白酶缺乏症疗法INBRX-101；同月与Synthekine合作开发IL-10受体激动剂布局炎症性疾病；9月与RadioMedix和Orano Med达成3.2亿欧元独家许可协议，开发基于同位素铅的放射性配体疗法；10月追加3亿欧元股权投资，加速与Orano Med在罕见癌症及下一代RLT领域的合作。诺和诺德2024年营收：约421亿美元2024年，诺和诺德重磅产品Wegovy（semaglutide，司美格鲁肽）注射液斩获心血管保护新适应症，成为获FDA批准用于辅助患有心血管疾病及肥胖或超重的成年人预防重大心血管事件的首款减重药物。在2024年欧洲肥胖大会（ECO）上，该公司公布了Wegovy的长期减重效果数据，其疗效可维持长达4年。诺和诺德突破性皮下注射血友病疗法Alhemo获FDA批准，是针对伴抑制物血友病A或B患者的同类疗法中的首款皮下注射治疗方案。该公司还达成多项超5亿美元的研发合作，聚焦利用表观遗传调控开发肥胖管理潜在新疗法、针对代谢功能障碍相关脂肪性肝炎（MASH）的小分子药物、分子胶降解剂的开发，以及利用肝外脂质纳米颗粒（LNP）递送技术推进针对心脏代谢性疾病和罕见病的创新基因药物（genetic medicine）的开发。GSK2024年营收：约401亿美元GSK的PD-1抑制剂Jemperli在局部晚期错配修复缺陷（dMMR）/高微卫星不稳定性（MSI-H）直肠癌患者中展现出前所未有的疗效，并获得FDA授予的突破性疗法认定。近期，该公司的抗生素gepotidacin获FDA批准上市，是近30年来首个治疗单纯性尿路感染的新型口服抗生素。疫苗方面，GSK的带状疱疹疫苗Shingrix的长期随访数据显示，其对50岁以上成人的保护效力持续超10年。2024年，GSK达成了多项超5亿美元的收购和合作协议，覆盖呼吸道疾病、自身免疫疾病、肿瘤及疫苗领域，包括收购Aiolos Bio公司以获得用于治疗哮喘的胸腺基质淋巴细胞生成素（TSLP）靶向单抗AIO-001，收购用于治疗B细胞驱动的自身免疫疾病的T细胞接合器（TCE）CMG1A46，引进映恩生物（Duality Biologics）的抗癌抗体偶联药物DB-1324，以及深化用于治疗传染病的mRNA疫苗的开发合作。安进2024年营收：约334亿美元2024年6月，美国FDA批准安进双特异性抗体疗法Blincyto（blinatumomab），用于年龄一个月或以上、CD19阳性、费城染色体阴性B细胞前体急性淋巴细胞白血病（B-ALL）患者的巩固阶段治疗，无论患者的可测量残留病灶状态如何。在一项3期临床试验中，接受诱导后巩固治疗的B-ALL患者的5年总生存率超80%。近期，该公司的抗CD19抗体Uplizna获FDA批准扩展适应症，用于治疗免疫球蛋白G4相关疾病（IgG4-RD）成人患者。新闻稿指出，这是治疗这一患者群体的首个获批药物。此外，安进的在研减重疗法MariTide于2024年年末公布了积极的2期研究结果，已进入3期开发阶段。在没有2型糖尿病的肥胖或超重人群中，MariTide在第52周实现了平均体重减轻约20%，且未出现体重减轻平台期。武田2024年营收：约309亿美元2024年4月，美国FDA批准了武田的Entyvio皮下注射制剂，用于中度至重度活动性克罗恩病人患者在接受Entyvio静脉注射制剂诱导治疗后的维持治疗，进一步巩固了其在炎症性肠病领域的布局。FDA还批准了该公司的Eohilia（布地奈德口服混悬液）上市，治疗11岁以上嗜酸性粒细胞性食管炎（EoE）患者。新闻稿指出，这是FDA批准治疗EoE的首款口服疗法。近期，武田的在研多肽疗法rusfertide作为真性红细胞增多症（PV）标准治疗附加方案的3期研究达到主要终点，80%的患者不再需要接受放血治疗。2024年，田达成数起超10亿美元的战略合作和许可协议，囊获多款创新疗法的开发权益，包括Kumquat Biosciences公司的一种新型免疫调节癌症小分子抑制剂、AC Immune公司的阿尔茨海默病疗法ACI-24.060、用于肿瘤学、神经科学和炎症领域多个靶点的新型分子胶降解剂，以及血液疾病创新疗法elritercept。勃林格殷格翰2024年营收：约290亿美元近期，勃林格殷格翰为其用于治疗NSCLC的小分子药物zongertinib（BI 1810631）递交了新药申请（NDA），该疗法获得了优先审评资格，有望于今年获批。新闻稿指出，如果获批，zongertinib将成为针对携带HER2突变、既往接受过全身治疗的不可切除或转移性NSCLC成人患者的首个口服靶向疗法。该公司用于治疗渐进性肺纤维化（PPF）的小分子抑制剂nerandomilast已达3期临床试验终点，即将递交上市申请。2024年6月，勃林格殷格翰公布了其胰高血糖素/GLP-1受体双重激动剂survodutide（BI 456906）的积极2期临床试验结果，并即将开展针对MASH的3期临床试验。在这项2期研究中，多达64.5%的中晚期（F2和F3期）肝纤维化成人患者的肝纤维化得到改善，且MASH未恶化。2024年，勃林格殷格翰达成多起超5亿美元的收购和合作协议，包括针对MASH的RNAi疗法、针对精神分裂症的小分子疗法、用于治疗癌症的细胞周期蛋白抑制剂和创新蛋白酪氨酸磷酸酶N1和N2（PTPN1和PTPN2）小分子抑制剂。吉利德科学2024年营收：约286亿美元2024年8月，美国FDA加速批准了吉利德科学斥资43亿美元收购的小分子疗法Livdelzi与熊去氧胆酸（UDCA）联合用于治疗对UDCA应答不足的原发性胆汁性肝硬化（PBC）成人患者，或作为单药治疗对UDCA不耐受的患者，但不建议患有或发展为失代偿性肝硬化的患者使用Livdelzi。根据新闻稿，Livdelzi是在碱性磷酸酶（ALP）正常化、关键生物标志物和瘙痒控制方面，与安慰剂相比表现出统计学显著改善的首个疗法。2025年2月，该疗法获欧盟批准，用于相同的适应症。此外，该公司的突破性长效HIV疗法lenacapavir已获得FDA授予的优先审评资格，预计在今年6月19日之前完成审评。该疗法的上市申请在欧洲也获得了加速审评。Lenacapavir是一种“first-in-class”长效HIV病毒衣壳抑制剂，可以干扰HIV病毒衣壳蛋白的组装和拆卸，在病毒生命周期的多个阶段发挥作用。在两项3期临床试验中，近100%接受每半年一次lenacapavir注射的受试者没有出现HIV感染。拜耳2024年营收：约260亿美元2024年3月，拜耳达成了一项3.1亿美元的合作，获得了在欧洲商业化BridgeBio Pharma公司用于治疗伴有心肌病的转甲状腺素蛋白介导的淀粉样变性（ATTR-CM）的在研疗法acoramidis的独家许可。该疗法目前已在美国、欧洲和日本获批上市，用于治疗ATTR-CM。该公司超8亿美元收购的双重神经激肽-1，3（NK-1，3）受体拮抗剂elinzanetant达3期临床主要终点，公司已向FDA递交NDA，寻求批准elinzanetant用于治疗与更年期相关的中度至重度血管运动症状（VMS，也称为潮热）。德国默克2024年营收：约191亿美元德国默克过去一年通过与多家新锐公司达成合作和授权交易，扩展研发管线。2024年3月，该公司与C4 Therapeutics（C4T）公司签订一项许可和合作协议，合作开发针对C4T在其内部发现管线中推进的两个关键致癌蛋白靶点的靶向蛋白降解剂。2024年6月，德国默克与Biolojic Design公司达成多靶点药物发现合作。该合作将利用Biolojic Design的AI驱动发现平台来设计用于治疗癌症和免疫疾病的治疗性抗体。梯瓦2024年营收：约165亿美元近期，梯瓦公司公布了其与赛诺菲共同开发的在研TL1A靶向单抗duvakitug在2b期临床试验中获得的积极结果。结果显示，接受duvakitug治疗的两大炎症性肠病——溃疡性结肠炎和克罗恩病的患者在第14周时均获得显著缓解。两家公司预计在今年下半年启动3期临床试验。此外，该公司用于治疗精神分裂症的长效缓释皮下注射疗法TEV-‘749已达3期临床试验主要终点。这款疗法利用名为SteadyTeq的缓释技术，让活性药物olanzapine能够在每月一次给药的治疗方案下通过持续释放维持治疗剂量。在一项近期公布的患者和医疗保健专业人员态度和体验调查研究中，超过92%的患者对TEV-‘749的起始治疗方案、给药方案和药物本身感到满意或非常满意。CSL2024年营收：约152亿美元CSL所开发的基因疗法Hemgenix在2022年11月与2023年2月分别获美国FDA与欧盟批准，用于对中度至重度血友病B患者进行一次性治疗。这款疗法在2023年荣获有“医药界诺贝尔奖”之称盖伦奖的最佳孤儿药/罕见病产品奖。此外，欧盟委员会已于今年2月批准“first-in-class”疗法Andembry上市，用于预防12岁及以上成年和青少年患者的遗传性血管性水肿（HAE）发作。新闻稿指出，它是首款只需每月一针、靶向血浆蛋白因子XIIa的HAE发作预防疗法。美国FDA目前正在针对该疗法进行审评。参考资料：[1] The top 20 pharma companies by 2024 revenue. Retrieved April 21, 2025, from https://www.fiercepharma.com/special-reports/top-20-pharma-companies-2024-revenue免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新
并购上市批准免疫疗法财报细胞疗法
2025-04-15
With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion.
LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's "
ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview
Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure.
Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation.
ENTYVIO Dosage
For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14.
Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @
ENTYVIO Market Potential
Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were
1.1 million diagnosed prevalent cases of Crohn's disease in the United States.
Current treatment approaches primarily include biologics such as
adalimumab (HUMIRA and its biosimilars),
ustekinumab (STELARA),
infliximab (REMICADE and biosimilars), along with
systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around
USD 4 billion in revenue for Crohn's disease treatment.
In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately
USD 8 billion, which is further expected to increase at a
CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease.
Discover more about the Crohn's disease market in detail @
Crohn's Disease Market Report
Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated
3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period.
According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing.
The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies,
anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices.
Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from
USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption.
For a comprehensive view of the ulcerative colitis market, check out the
Ulcerative Colitis Market Assessment
Emerging Competitors of ENTYVIO
Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes.
RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement.
VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation.
TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while
ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression.
Additional pipeline therapies include
Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and
Pfizer's JAK3 inhibitor LITFULO in Phase II.
Teva and Sanofi are also developing
Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments.
A range of other promising candidates are in development, each targeting unique pathways.
Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while
AVB-114 from
Avobis Bio/Alimentiv is also in Phase II.
Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124.
Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and
Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential.
Other noteworthy agents in Phase II include
Zasocitinib (TAK-279) from
Takeda, a TYK2 inhibitor;
AZD7798 from
AstraZeneca, targeting CCR9;
Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling;
AGMB-129 from
Agomab Therapeutics, targeting ALK5/TGFβR1;
MBF-118 by
Medibiofarma, a PPARγ partial agonist; and
MORF-057 by
Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline.
To know more about the number of competing drugs in development, visit @
ENTYVIO Market Positioning Compared to Other Drugs
Key Milestones of ENTYVIO
In
April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO.
In
September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO.
In
September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO.
In
April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO.
In
March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis.
In
May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease.
In
May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease.
In
May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis.
In
November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis.
In
June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease.
In
May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors.
In
May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease.
Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @
ENTYVIO Infusion
ENTYVIO Market Dynamics
ENTYVIO has established itself as a
leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to
anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its
favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies.
The biologics market for inflammatory bowel disease is
highly competitive, with key players including
HUMIRA, REMICADE, STELARA, and newer entrants like
SKYRIZI and RINVOQ. ENTYVIO has managed to capture
significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its
intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the
subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia.
Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to
patent protections, with
biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as
expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge.
Moreover, the shift in
payer dynamics and healthcare cost
containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success.
Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @
ENTYVIO Market Drug Report
Table of Contents
Related Reports
Crohn's Disease Market
Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies including
Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others.
Crohn's Disease Pipeline
Crohn's Disease Pipeline Insight
– 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including
Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others.
Ulcerative Colitis Market
Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including
Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others.
Ulcerative Colitis Pipeline
Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Ulcerative Colitis companies, including
Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others.
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临床2期上市批准临床3期免疫疗法
100 项与 MORF-057 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 克罗恩病 | 临床2期 | 美国 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 奥地利 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 巴西 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 加拿大 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 哥伦比亚 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 克罗地亚 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 捷克 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 法国 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 格鲁吉亚 | 2024-04-04 | |
| 克罗恩病 | 临床2期 | 德国 | 2024-04-04 |
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临床结果
临床结果
适应症
分期
评价
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 35 | 鑰憲醖夢遞繭願遞繭襯(艱鏇鬱襯選醖簾網鬱衊) = 觸廠壓製顧顧膚餘鹹廠 製網夢蓋製鑰衊製構廠 (醖淵選襯網鬱鬱膚繭膚, 11.18) 更多 | - | 2024-11-26 | |||
临床2期 | - | 鏇窪窪蓋鑰網鏇選觸艱(淵製憲齋構窪願衊壓網) = 糧窪壓窪膚衊衊艱艱網 鹹構蓋築膚夢鏇築壓糧 (鏇夢構膚鹽淵夢獵蓋淵 ) 达到 更多 | 积极 | 2023-11-03 | |||
N/A | - | MORF-057 100 mg BID | 鹽積膚繭範鏇衊艱齋鏇(淵衊鹹憲遞鑰襯繭範繭) = anemia in 3 (8.6%) patients 觸選廠繭淵築窪醖醖鑰 (淵憲壓範襯淵鑰構網蓋 ) 更多 | - | 2023-10-15 | ||
临床1期 | - | 33 | 衊簾糧鹽艱積憲鬱積製(積鑰蓋淵鹹積鏇廠餘鬱) = The percent change of ITGβ7+CD19+ BSM cells from baseline was significantly greater for all dose groups compared to PBO 餘鏇廠衊齋顧遞衊鬱鏇 (鏇廠鹽窪壓鏇壓齋襯繭 ) | 积极 | 2022-10-08 | ||
Placebo | |||||||
N/A | - | - | 窪範選淵壓憲選餘願獵(構鏇繭遞憲衊艱顧觸選) = 醖範網齋鹽膚構醖壓簾 壓鑰蓋願蓋構遞獵選鹽 (艱衊鏇糧範淵夢顧構顧 ) 更多 | - | 2020-10-01 |
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