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更新于：2025-04-23

Darvadstrocel(TiGenix)

更新于：2025-04-23

概要

概要

基本信息

药物类型

间充质干细胞疗法

别名

Darvadstrocel、CX601、Alofisel

+ [1]

靶点-

作用方式-

作用机制

细胞替代物

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

The Spanish Association of Biotech companies (ASEBIO)

TiGenix NV

Takeda Pharmaceutical Co., Ltd.

+ [1]

非在研机构

Hospital Universitario La Paz

Takeda Canada, Inc.

最高研发阶段批准上市

首次获批日期

欧盟 (2018-03-23),

肛瘘

最高研发阶段(中国)-

特殊审评-

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关联

项与 Darvadstrocel(TiGenix) 相关的临床试验

NCT05974280

/ RecruitingN/AIIT

Pilot Study on the Treatment of Anal Fistulas in Crohn's Disease Patients Using Alofisel Versus Fat Autologous Stem Cells

One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells.
The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy.
This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed.
Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided.
An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities.
We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.

开始日期2024-01-02

申办/合作机构

Nantes University Hospital

NCT05113095

/ RecruitingN/A

Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance)

This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.

开始日期2021-11-30

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT04701411

/ Active, not recruiting临床3期

A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks

A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel.
2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic.
For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment).

开始日期2021-06-30

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

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100 项与 Darvadstrocel(TiGenix) 相关的临床结果

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100 项与 Darvadstrocel(TiGenix) 相关的转化医学

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100 项与 Darvadstrocel(TiGenix) 相关的专利（医药）

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项与 Darvadstrocel(TiGenix) 相关的文献（医药）

2025-04-01·United European Gastroenterology Journal

Darvadstrocel for complex perianal fistulas in Crohn's disease: A systematic review and meta‐analysis

Review

作者: López‐García, Olga N. ; Taxonera, Carlos ; García‐Brenes, Miguel A. ; Zapater, Raúl ; Alba, Cristina ; Olivares, David

Abstract:

Background:

Local injection of darvadstrocel, a suspension of expanded adipose‐derived allogenic mesenchymal stem cells, has been used for treatment‐refractory perianal fistulas in Crohn's disease (CD).

Objective:

This study aimed to investigate efficacy and safety of darvadstrocel for complex perianal fistulas in CD.

Methods:

A systematic search was conducted through April 2024 in relevant databases for observational studies evaluating darvadstrocel. A random‐effects meta‐analysis model was used to calculate the pooled effect sizes (proportions or incidence rates [IRs]) with 95% confidence intervals (CIs) of effectiveness and safety outcomes. The risk of bias was evaluated using the Joanna Briggs Institute Critical Appraisal Tool. The I2 value assessed heterogeneity. Sensitivity and subgroup analyses were also conducted.

Results:

Twelve studies were included with 595 patients. The pooled rate of patients achieving clinical remission, defined as fistula healing, was 68.1% at month 6 (95% CI 63.4–72.7) and 77.2% (95% CI 70.1–83.8) at month 12. Combined remission, defined as clinical remission and absence of collections >2 cm confirmed by magnetic resonance imaging, was reported in 60.6% and in 69.7% of patients at months 6 and 12, respectively. The rate of patients with treatment failure, defined as no clinical remission at the last follow‐up (mean 18.7 months; SD 9.9), was 34.5%. Failure rate was independent of follow‐up time (p = 0.85). For effectiveness outcomes, between‐study heterogeneity was negligible. Subgroup analysis indicated that none of the covariates modified the treatment effect. Pooled IRs per 100 patient‐years of adverse events (AE), serious AEs, perianal abscesses, and reoperations were 19.6, 3.2, 16.9 and 7.1, respectively.

Conclusion:

Evidence from observational studies supports the efficacy and safety of darvadstrocel for complex perianal fistulas in CD. Studies have reported high fistula healing rates that can be sustained long‐term in most patients, with negligible between‐study heterogeneity, as well as a favorable safety profile.

2025-03-05·Journal of Crohns & Colitis

Corrigendum: Darvadstrocel for Complex Perianal Fistulas in Japanese Adults with Crohn’s Disease: A Phase 3 Study

2025-03-03·INFLAMMATORY BOWEL DISEASES

Allogenic Stem Cells in Anal Fistulas of Crohn’s Disease: From Promising Premises to Real Life Experience

Article

作者: Sabbagh, Charles ; Etienney, Isabelle ; Brochard, Charlène ; Siproudhis, Laurent ; Cotte, Eddy ; Bouchard, Dominique ; Zerbib, Philippe ; Fathallah, Nadia

Abstract:

Background:

Allogenic adipocyte stem cells represent an unprecedented opportunity for regenerative therapy to treat Crohn anal fistulas. Apart from the results of one 8-year-old trial, scientific evidence remains scarce.

Methods:

Data from consecutive patients treated with darvadstrocel for Crohn anal fistulas were reviewed at 6 first tertiary reference centers. The judgment criteria combined asymptomatic status plus clinical occlusion of the fistula tract and MRI-confirmed healing of the tract (no inflammation and/or disappearance of the tract). Both clinical and MRI-confirmed healing of the tract defined a deep remission. Clinical remission was defined by an absence of complaint, occlusion of all external openings, and no fistula discharge.

Results:

A total of 116 patients were extracted (median follow-up after cell stem injection: 11 [6-14] months). No severe adverse events were reported after surgery except for subsequent anal surgery in 29 (25%) patients. Fifty-one (44%) patients had clinical remission defined by the absence of complaints, the occlusion of all external openings, and the presence of no fistula discharge. Deep remission was observed in 23 (29%) patients. Patients with clinical remission more often received combined therapy (immunosuppressant antitumor necrosis factors) than those with no improvement (31 of 51 [61%] vs 23 of 65 [35%]; P = .007). Regression analysis showed that high fistulas (odds ratio, 3.8 [1.1-12.5]; P = .03) and younger age (<38 years, odds ratio, 2.3 [1.0-58;4]; P = .02) were associated with a better outcome.

Conclusions:

Allogeneic stem cell treatment of Crohn’s anal fistulas results in complete remission in less than half of patients, with a significant reintervention rate.

项与 Darvadstrocel(TiGenix) 相关的新闻（医药）

2025-02-10

·蒲公英Ouryao

2024年度间充质干细胞研究突破及2025年技术革新前瞻

作者 | 牟春琳（华域生物联合创始人）来源 | 蒲公英Ouryao 间充质干细胞（Mesenchymal stem cells，MSCs）是干细胞研究的重要分支，其来源于中胚层，广泛存在于全身多种组织中，几乎来源于机体所有的组织器官，如骨髓、骨膜、脂肪组织、牙髓、滑膜、脐带、胎盘、羊水及胎儿组织等, 不仅获取简单，也避开了可能存在的伦理风险。 MSCs除了具有自我更新和多向分化能力之外，还在造血支持、调节免疫炎症反应、促进血管新生等功能中起重要调节作用；并且由于其低免疫原性，不会刺激机体产生免疫应答，临床移植后安全性高，无免疫排斥作用，在再生医学与细胞治疗方面展现出了惊人的应用潜力，广泛应用于多种自身免疫性疾病、血管性疾病、糖尿病等代谢性疾病、退行性疾病、组织器官损伤等。 2024年，随着政策支持、技术创新及临床转化加速，MSCs技术和应用在多个疾病领域取得突破性进展。本文系统梳理了2024年MSCs治疗的关键进展，并展望2025年的发展趋势。 1 干细胞产业规模持续扩大近年来，全球及中国的干细胞医疗行业市场规模均呈现出显著的增长趋势。根据中研普华产业研究院发布的《2025-2030年中国干细胞医疗行业市场竞争形势分析及未来发展前景预测报告》显示：全球干细胞市场规模预计将从2023年的150亿美元增长至2034年的488.3亿美元，年复合增长率高达11.3%。中国干细胞医疗行业市场规模逐年上涨，从2018年的474.26亿元上涨至2023年的800亿元（有数据显示2023年为1257亿元，可能与统计口径或数据来源不同），再到2024年预计的265亿元（仅指干细胞治疗市场规模，采集制备储存市场规模近160亿元）。数据来源：《2024中国干细胞行业市场研究报告》近十年众多企业入局细胞行业，竞争企业数量越来越多且业务从干细胞到免疫细胞多样化发展。然而，干细胞存储在细胞存储市场中占比约八成，仍然是当前最主流的细胞存储类型。因此，干细胞企业面临的替代性竞争风险较小，尤其有新生儿干细胞存储市场优势的企业积累较为深厚，持续性经营能力或更强。数据来源：《2024中国干细胞行业市场研究报告》这些数据表明，干细胞存储和干细胞医疗行业具有广阔的发展前景和巨大的市场潜力。 2 政策扶持加速产业发展为推动细胞产业规范发展，我国近年来陆续颁布了多项监管和产业支持政策，行业发展环境持续改善。2024年度出台的一系列支持性国家和地方政策，涵盖了从基础研究到临床应用的全链条支持，为细胞治疗产业的发展提供了有力的政策保障。 2月新修订的《产业结构调整指导目录》，将细胞治疗药物、细胞培养明确列入鼓励类产业目录，标志着我国政府对细胞治疗领域的重视和支持达到了新的高度，为细胞治疗药物的研发、生产和市场推广提供了强有力的政策支撑。 5月，北京药监局核发了全国首张干细胞《药物生产许可证》，意味着我国干细胞药品研发和生产正式进入了有证可依的新阶段。 8月，国家卫生健康委科教司发布国家重点研发计划重点专项2024年度项目申报指南，“干细胞研究与器官修复”被列为其中6个重点专项之一，体现了国家对科研资源和政策支持的持续重视，不仅为研究机构和企业提供了更多的资金与资源，也为研究人员指明了未来的发展方向。 9月，工信部发布了《关于加快布局建设制造业中试平台的通知》，在药品领域，聚焦细胞和基因治疗等重点创新方面，布局建设智能化绿色化中试放大平台，鼓励采用CRO与CDMO模式，有效缩短细胞产品的研发周期，降低研发成本，为行业提供强有力的政策支持和发展动力，推动细胞治疗技术的商业化进程。同时，商务部、国家卫生健康委、国家药监局也在9月联合发布了关于在医疗领域开展扩大开放试点工作的通知，在北京、上海、广东三大自贸区及海南自贸港，允许外国投资企业参与人体干细胞、基因诊断与治疗技术的深入研发和应用。这一政策为外资企业在我国进行尖端医疗技术研发开辟了广阔的空间，推动了国内外医疗技术之间的互动与联合。 12月，海南博鳌乐城发布了《海南自由贸易港博鳌乐城国际医疗旅游先行区生物医学新技术促进规定》，通过简化审批流程、提供政策支持，开辟了干细胞技术从临床研究向转化应用的快速通道，在先行区依法依规开展合理性收费水到渠成。这些政策的出台，不仅为细胞治疗技术的研发和应用提供了有力的支持，也为相关企业的发展创造了良好的政策环境，推动了细胞治疗产业的快速发展。 3 技术创新驱动功能升级干细胞技术创新在2024年也取得了显著进展，在人工智能、生物材料、3D打印，基因编辑以及抗衰老等方面都取得了一定成果。干细胞与人工智能的结合为再生医学和疾病治疗带来新的希望。从数据规范化共享到AI模型的设计，再到深度学习在干细胞命运预测中的应用，这些进展不仅推动了干细胞科学研究的进展，也为临床应用中的标准化和效率提升提供了支持。将人工智能与活细胞成像技术结合，可以从复杂细胞群体中实时提取空间和时间信息，以了解其组成并预测进化过程，从而设计将干细胞分化为特定细胞类型。在干细胞与生物材料结合方面，华东理工大学刘昌胜院士团队提出了一种新型的“自体MSC原位授权”策略，通过植入负载骨形态发生蛋白2（BMP-2）的生物活性材料在体内构建类骨组织，借助发育早期的炎性微环境来激活MSCs的免疫调节功能。该方法所获得的自体MSCs具有更低的免疫原性，可在宿主中长期存活，且在更长时间内保持免疫调节能力。小鼠溃疡性结肠炎动物实验显示获得显著效果，降低死亡率，重塑结肠部位炎症生态位。这种由植入活性材料而产生的自体来源MSC为干细胞治疗提供了新的细胞来源[1]。上海交通大学医学院附属新华医院的研究团队提出了一种创新性的工程化方法，将干细胞与水凝胶结合形成生物墨水，并运用3D打印技术，精准创建出结构复杂的骨类器官，植入体内后表现出自发矿化和成熟的特点，最终形成了完全分化且血管化的骨组织[2]。北京吉源生物科技有限公司通过将成纤维细胞生长因子FGF21和胰高血糖素样肽GLP-1两种糖脂代谢调控分子作为“药物子弹”装载到脂肪间充质干细胞中，既能实现对糖脂代谢的调控作用，还可利用归巢特性实现靶向局部治疗，起到保护胰岛β细胞和抑制并发症的效果，在矫正2型糖尿病代谢紊乱和修复组织器官等方面取得了重大突破。“人GLP-1和FGF21双因子高表达脂肪干细胞注射液”新药临床试验申请在2024年获得CDE默示许可，是国内首次使用基因修饰间充质干细胞治疗2型糖尿病的临床试验申请。除了干细胞本身以外，其来源的外泌体因其体积小、低免疫原性、富含多种活性物质，也是研究开发的重点。北京航空航天大学刘海峰教授团队与军事医学科学研究院郭希民研究员团队开发了工程化牙髓间充质干细胞源细胞外囊泡与透明质酸基多功能水凝胶结合的水凝胶支架材料，可用于治疗由于创伤、骨折、炎症、先天性疾病或者肿瘤等导致的严重骨缺损，促进受损骨组织重塑[3]。北京理工大学张金凤教授团队与暨南大学第一附属医院胡敏副研究员团队利用将MSCs来源的外泌体作为天然的生物活性载体，同时递送肝细胞生长因子（HGF）和谷胱甘肽（GSH），形成一种全生物活性的纳米药物，能够有效治疗四氯化碳（CCl4）和极量肝切除术诱导的急性肝衰竭[4]。上海东方医院江华教授团队开展了一项随机、双盲、安慰剂对照研究，观察了静脉输注MSCs治疗老年衰弱的安全性和有效性研究。该研究共筛选了110名潜在的参与者，最终30名老年衰弱患者被随机分配到MSCs组和安慰剂组，以评估干细胞疗法的效果。这项研究不仅证实了MSCs治疗老年衰弱的安全性和有效性，还揭示了其在改善生活质量、增强机体功能和抗炎作用方面的潜力。随着对MSCs治疗机制的进一步研究和更多临床试验的开展，未来这种治疗方法有望成为改善老年人生活质量的重要手段[5]。以上学术和临床进展为未来间充质干细胞及其衍生物在基因修饰促进成药性方面，在与材料结合方面，在细分治疗领域方面的发展奠定了坚实的基础。 4 细胞新药研发进入「快车道」 2024年我国干细胞新药研发进入快车道。截至2024年底，中国已记录了146个干细胞新药的临床试验申请（IND），其中109个新药成功获得了临床试验的批准。从2024年1月1日到12月25日，中国新增了32个干细胞新药的IND申请，且有28个新药获得临床试验的默示许可。这些进展显示了干细胞新药研发的活跃态势和快速增长。 2024年，28项新药临床试验获批，这些批件由27家不同的公司获得，显示出行业的广泛参与和发展。在这些新药中，2项诱导多能干细胞（IPSC）产品，3项经过基因编辑的造血干细胞产品，以及1项基因修饰的间充质干细胞（MSC）产品。剩余的22项均为MSC产品，其中17项来源于脐带，2项来源于脂肪，1项来源于骨髓，1项来源于宫血，还有1项来源于羊膜。这表明MSC产品在新药研发中占据了主导地位，尤其是脐带来源的MSC，其市场竞争尤为激烈，其中脐带来源MSCs竞争尤为激烈[6]。值得振奋的是，我国干细胞疗法在临床应用上终于迈出关键一步。2025年1月2日，国家药监局批准我国首款干细胞治疗药品艾米迈托赛注射液上市，这款异体来源人脐带间充质干细胞产品用于治疗14岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病（aGVHD）。该产品所有公司铂生卓越生物科技（北京）有限公司，早在2013年就递交了IND申请，并于2020年2月首次获批临床，2024年5月由北京市药监局核发了全国第一张干细胞《药品生产许可证》，并于6月被CDE纳入优先审评审批，历经十多年。目前该药物仍在进行III期临床试验，虽然此次是通过优先审评审批程序附条件获批上市，但依然是国内干细胞产业在商业化应用方面的一次重大突破。就在此前不久，美国FDA于2024年12月18日重磅批准了RYONCIL®（Remestemcel-L）上市。这款具有开创性意义的首款间充质干细胞产品源自同种异体骨髓，针对2个月及以上儿科患者的类固醇难治性急性移植物抗宿主病（SR-aGVHD），此产品同样经过了10几年的研发上市之路。美国与中国先后成功获批干细胞治疗产品均为间充质干细胞药物，且适应症均为GVHD，说明GVHD的严重性和医疗需求可能加快药物审批，可作为干细胞成药的一个切入点。另外，2024年版的中国《骨关节炎诊疗指南》，将MSCs关节内注射列为B级证据推荐，减少关节内炎症细胞、促进关节软骨生长并进一步改善患者的疼痛和功能，可作为治疗轻度至中度骨关节炎的潜在方法。 5 技术瓶颈持续攻坚尽管干细胞研究取得了诸多进展，但仍存在技术上的瓶颈： 01 药代动力学与疗效机制不明确 MSCs在体内的动态分布、迁移效率及长期存活率仍不清晰，影响剂量标准化。研究表明，大多数静脉注射的MSCs驻留在肺部，如何使MSCs归巢到损伤部位发挥作用十分重要。 02 干细胞异质性导致疗效差异同一干细胞群体中存在基因表达、蛋白质表达、表观遗传修饰、细胞形态、代谢途径等方面的生物学差异。虽然通过单细胞RNA测序等技术可识别出多个功能亚群，并分析每个亚群的主要功能差异，但仍需解决将所需功能亚群细胞分选的技术难点和特殊培养基的定制难度。攻克这些难度，才可以大大提高治疗的一致性，加强治疗效果。 03 生产标准化难题不同来源、不同培养条件、冻存技术均会导致MSCs的异质性，从而导致疗效波动。2024年全球仅2款MSC产品获批，也凸显了标准化生产和质量控制的重要性。每种干细胞MSCs产品需严格控制生产流程，统一标准以减少可能的疗效差异。 04 临床转化障碍尽管临床前研究成功率高，但部分III期试验未能验证疗效（如武田制药同种异体脂肪间充质干细胞产品Alofisel），可能需要采取细胞功能优化及患者分层策略。 6 2025年展望：从技术突破到临床普及 2024年标志着MSCs从“概念验证”迈向“临床刚需”，取得了里程碑进展，但标准化生产和疗效验证仍是核心挑战。未来需加强跨学科协作，推动基础研究向临床应用的快速转化，最终实现再生医学的全民可及性。 2025年，随着生物材料、基因编辑、人工智能与合成生物学的深度介入，MSCs有望突破传统治疗边界，从“潜力股”转化为普惠医疗工具，成为攻克多种临床难治性疾病的重要武器，从而见证技术与商业化的双重爆发。参考资料： [1] . In situ licensing of mesenchymal stem cell immunomodulatory function via BMP-2 induced developmental process.PNAS.November 20, 2024. [2] . Protocol for engineering bone organoids from mesenchymal stem cells.Bioact Mater. 2024 Dec 1;45:388–400. [3] . Osteoinductive dental pulp stem cell-derived extracellular vesicle-loaded multifunctional hydrogel for bone regeneration.ACS Nano.March 15, 2024. [4] . Fully Bioactive Nanodrugs: Stem Cell-Derived Exosomes Engineered with Biomacromolecules to Treat CCL4- and Extreme Hepatectomy- Induced Acute Liver Failure.ACS Nano.December 3, 2024. [5] . Safety and e cacy of umbilical cord tissue-derived mesenchymal stem cells in the treatment of patients with aging frailty: a phase I/II randomized, double-blind, placebo-controlled study [6] . James干细胞之父，《2024年干细胞治疗领域的年度总结》，2025.01.01 作者简介牟春琳博士华域生物联合创始人，首席技术官简介：曾在中国食品药品检定研究院从事干细胞研究工作。天津泰达国际心血管病医院“干细胞临床研究学术委员会”委员；天津大学--国家重点研发计划“组织工程类脑智能复合体设计与开发”项目专家；《干细胞治疗与干细胞制剂》丛书编委；中国医药生物技术协会第七届理事会理事。国家科技部十三五重大专项 “干细胞及转化研究”项目“人脐带间充质干细胞修复脊髓损伤的临床研究”课题负责人，天津市生物医药科技重大专项牵头人，宁波市重点研发计划项目负责人，及多个省市科研项目负责人。参与多项干细胞临床研究备案项目并备案成功。授权发明专利9项，授权实用新型14项，发表SCI论文数十篇。声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。推荐阅读 1、2024年中国生物行业主要政策回顾与盘点作者：滴水司南 2、回顾展望生物医药：2024深度转型，2025破冰发展作者：张金巍 3、2024年生物医药产业政策盘点（附政策包下载）作者：芝麻核桃 4、生物医药产教融合：推动产业可持续发展的关键路径作者：李峰 5、从"卡脖子"到"自主可控":生物医药供应链国产替代进行时作者：杨清 6、生物制品抗体行业的2024 作者：黄庆 7、7大亮点回顾2024全球ADC产业图景作者：药明合联 8、细胞治疗2024：盘点行业的破局之道作者：张长风博士 9、开启生命科学新纪元：2024基因治疗全景复盘作者：马景梅蒲公英生物运营团队恭贺新春灵蛇献瑞巳巳如意

细胞疗法

2025-01-28

·药事纵横

2024年被拒批、延迟、终止的CGT疗法

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。回顾 2024 年，细胞和基因疗法（CGT）领域可谓是波澜壮阔，在取得诸多突破的同时，也面临着部分疗法受挫的情况。来源：细胞基因疗法前沿据不完全统计，2024 年全球有 17 款 CGT 疗法获批上市。当然也有一部分CGT疗法遭遇挫折，或被拒批，或延迟审批或临床试验被迫终止。例如，一些企业的 CGT 产品由于在临床试验中未能达到预期的疗效终点，或者出现了安全性问题，导致审批受阻。还有部分产品因生产工艺复杂、质量控制难度大等问题，无法满足监管部门的要求，从而延迟了上市进程。具体如下：拒批 EB-101 4 月 22 日，Abeona Therapeutics 的细胞疗法prademagene zamikeracel (pz-cel，EB-101)上市申请遭拒，FDA 要求其提供治疗的有效信息及满足额外的 CMC 要求。 EB-101用于治疗隐性营养不良性大疱性表皮松解症患者。它是一款自体的细胞与基因治疗，使用逆转录病毒载体将COL7A1基因导入患者自身的皮肤细胞(角质形成细胞)，并将其移植回患者体内，以使正常的VII型胶原蛋白表达和促进伤口愈合。 Kresladi 6 月 28 日，Rocket Pharmaceuticals 的基因疗法Kresladi™ （marnegragene autotemcel; marne-cel）被拒批，FDA 要求提供有限的额外化学制造和控制 (CMC) 信息以完成审查。 Kresladi（曾用名RP-L201）用于治疗严重白细胞粘附缺陷，是一款用以治疗严重白细胞粘附缺陷-I（LAD-I）的在研基因疗法，该疗法通过慢病毒对患者的自体造血干细胞进行基因工程化改造，以递送ITGB2基因的功能性拷贝。延迟 Ryoncil：Mesoblast 的间充质干细胞疗法 Ryoncil 在审批过程中历经波折，曾收到 2 封 CRL（申请拒绝），直到 2024 年 12 月 18 日才获批上市，用于治疗激素难治性急性移植物抗宿主病。暂停或终止 vx-880 ：1 月 7 日，因两名患者死亡，Vertex 暂停细胞疗法 vx-880 的临床试验，等待独立数据监控委员会和全球监管机构对全部数据的审查。vx-880 是一种干细胞衍生的胰岛细胞疗法，用于治疗 1 型糖尿病。 Posoleucel：1月上旬，AlloVir宣布终止核心产品Posoleucel 的三项3期临床试验。Posoleucel是一种实验性的多病毒特异性T细胞疗法，AlloVir停止的3项临床试验，分别是用于预防多种病毒引起的感染或疾病，治疗病毒相关的出血性膀胱炎（vHC）和治疗腺病毒（AdV）。 fordadistrogene movaparvovec ： 5 月 7 日，一名杜氏肌营养不良患者在使用辉瑞的基因疗法 fordadistrogene movaparvovec的 2 期临床试验中去世，死因是心脏骤停。辉瑞随后暂停了其针对 4 到 8 岁男孩的随机、安慰剂对照 3 期试验 CIFFREO 中的患者交叉试验。两个月后，辉瑞宣布 3 期 CIFFREO 研究未达到主要终点，也未达到关键次要终点，决定终止开发这款产品。 giroctocogene fitelparvovec： 12 月 30 日，辉瑞宣布终止与 Sangamo 在 A 型血友病基因疗法 giroctocogenefitelparvovec上的合作。辉瑞经多方统筹分析，认为目前患者对额外基因治疗选择的兴趣非常有限。 spk-3006 ：是由罗氏子公司 Spark Therapeutics 开发的一种肝靶向的 AAV 试验性基因疗法，用于治疗庞贝病。在罗氏 2024 年上半年的管线梳理中，决定剔除该项目，停止了对其的临床开发。停止试验的决定不是由于安全问题，而是作为 Spark 内部战略组合优先级的一部分做出的。 GLPG5301：Galapagos 公司研发的一款 BCMA CAR-T 疗法 GLPG5301，主要用于治疗成人复发 / 难治性多发性骨髓瘤。因一名患者出现帕金森综合症而在 2024 年 8 月暂停所有临床。不过好在经过审查和采取额外的安全措施后，已于 2024 年第三季度恢复招募。退出 Alofisel（Darvadstrocel）：是一种同种异体间充质干细胞疗法，于2018年在欧盟获批，用于治疗对至少一种常规或生物疗法无效的非活动性/轻度活动性管腔克罗恩病的成人患者的复杂肛周瘘‌。然而，12月13日，武田制药公司宣布自愿撤销Alofisel在欧盟的营销授权。这一决定是基于补充临床试验结果，显示该药物未能达成主要和次要终点，且疗效不如预期‌。回顾 2024 年 FDA 对这些 CGT 疗法的审批动态，无论是获批上市、拒绝还是延迟，都深刻影响着患者的治疗希望、企业的发展命运以及整个行业的未来走向。审批过程中的种种要求与决策，不仅是对疗法安全性和有效性的严格把关，更是推动 CGT 领域朝着更加规范、成熟方向发展的重要力量。参考资料：公开资料

基因疗法细胞疗法上市批准ASH会议临床2期

2025-01-10

·Business Wire

Clinical and Commercial Developments in MSCs: 1,670+ Trials Highlight Versatile Applications and Emerging Opportunities - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2025" report has been added to ResearchAndMarkets.com's offering. MSCs are multipotent cells that have been referred to as mesenchymal stem cells, medicinal signaling cells, and mesenchymal stromal cells, reflecting their versatility and diverse applications. MSCs can differentiate into a variety of cell types, such as osteoblasts, chondrocytes, myocytes, and adipocytes. Their unique ability to secrete factors that promote tissue repair and modulate their microenvironment with anti-inflammatory and anti-fibrotic effects makes them essential in regenerative medicine. Furthermore, their immuno-evasive properties make MSCs particularly suitable for allogenic transplantation. MSCs serve as vital raw materials across numerous industries, including regenerative medicine, cosmeceuticals, and cultured meat production. Key applications include: Cell-based therapies for musculoskeletal diseases, spinal injuries, and cardiovascular conditions. Engineered tissues and organs, such as skin, bone, blood vessels, and liver. Cell-derived products, such as exosomes and growth factors, utilized in cosmetics and skincare. Cultured meat production, leveraging MSCs' role in muscle development and their ability to differentiate into muscle and fat cells. Globally, 12 MSC-based therapies have been approved for various indications, with the majority concentrated in South Korea, Japan, and the EU. Specifically, the Republic of Korea has approved five products: Queencell from Anterogen, Cellgram AMI from Pharmicell, Cupistem from Anterogen, Cartistem from Medipost, and NeuroNataR from Corestem. Japan has approved two products: Temcell HS from JCR Pharmaceuticals and Stemirac from Nipro Corporation. The EMA in Europe has approved two products: Holoclar from Chiesi Farmaceutici and Alofisel from TiGenix/Takeda. India has approved one product: Stempeucel from Stempeutics. Iran has approved one product: MesestroCell developed by Cell Tech Pharmed. Finally, Australia has approved one product: Remestemcel-L from Mesoblast. Despite this progress, no MSC-based therapeutic have yet received U.S. FDA approval, although the FDA is actively reviewing Mesoblast's Remestemcel-L. The cosmeceutical market is also rapidly adopting MSC-derived products, particularly exosomes, to leverage their anti-aging and regenerative properties, with companies like L'Oreal and Johnson & Johnson investing heavily in this space. Similarly, cultured meat companies are utilizing MSCs for producing muscle and fat cells, enhancing taste and texture. Groundbreaking approvals, such as lab-grown chicken by Upside Foods and Good Meat, have paved the way for further growth in this industry. MSC-based gene editing is expanding, enabling the overexpression of antitumor genes and therapeutic factors. Researchers are also exploring the use of MSCs in 3D printing and engineered organ production, with breakthroughs anticipated in the next decade. Importantly, companies like Cynata Therapeutics are pioneering iPSC-derived MSC production technologies, enabling large-scale therapeutic development. Today there are at least eight companies who are involved with the development of iPSC-derived MSCs therapeutics (iMSCs), including Cynata Therapeutics, Eterna Therapeutics, Implant Therapeutics, Bone Therapeutics, Brooklyn ImmunoTherapeutics, Fujifilm CDI, Citius Pharmaceuticals, and Kiji Therapeutics. There are also over 1,670 clinical trials involving MSCs are registered on ClinicalTrials.gov. Nearly 75% of these clinical studies are using MSCs for the development of regenerative medicine (RM) products. Approximately 14% of the studies are using MSCs for disease modeling. The remaining 11% of the studies are using MSCs for drug discovery and cytotoxicity testing applications. Challenges in these trials include maintaining MSC phenotype and functionality during expansion. However, ongoing advancements suggest a promising future, with projections for at least 50 globally approved MSC-based products by 2040, averaging 3-4 new approvals annually. Key Players in MSC Research Products The demand for MSC-based research products has surged in recent years, with major suppliers expanding their portfolios. Companies like RoosterBio have increased the access to quality MSCs through supply chain industrialization, standardized cell bank product forms, and fit-for-purpose cGMP-compatible cells and media systems. Other leading MSC research product suppliers include PromoCell, Lonza, Thermo Fisher Scientific, STEMCELL Technologies, Miltenyi Biotec, Bio-Techne (R&D Systems), ScienCell Research Laboratories, and the ATCC. Challenges and Opportunities While MSC commercialization faces hurdles-such as scalability and regulatory approval-opportunities abound. The market for MSC-based products is poised for notable growth across the research, therapeutic, cosmetic, and food industries. Within this rapidly changing landscape, having a thorough understanding of the competition is essential. This global strategic report presents rates of MSC clinical trials, scientific publications, patents, funding events, and collaborations. It presents the pipeline for MSC-based therapeutics, identifies market opportunities and threats, and explores future directions and emerging applications. It reveals innovative MSC products, services, and technologies offered by 125 leading competitors. Finally, it presents detailed market size figures for the global MSC market, segmented by geography and business segment with future forecasts through 2031. Key Topics Covered: MESENCHYMAL STEM CELLS (MSCs): AN OVERVIEW Stabilization of hMSCs as a Technology The Impact of MSCs on Regenerative Medicine Timeline of MSC Nomenclature Sources of MSCs Cell Surface Markers in MSCs In vitro Differentiation Potentials of MSCs Soluble Factors Secreted by MSCs Stemness Genes Present in MSCs Types of MSCs and their Biomedical Applications Genes that are Pivotal for MSC's Properties MSC-BASED CLINICAL TRIAL LANDSCAPE MSC-Based Clinical Studies by Geography Sources of MSCs used in Current Clinical Trials Share of Autologous & Allogeneic MSCs Clinical Trials MSC-Based Clinical Trials by Disease Indication MSC-Based Clinical Trials by Phase of Study Select MSC-Based Clinical Trials MESENCHYMAL STEM CELLS (MSCS): PATENT LANDSCAPE MSC Patent Publications by Jurisdiction MSC Patent Applicants MSC Patent Inventors MSC Patent Owners Legal Status of MSC Patent Applications MSC-Derived Exosome Patents Patents for iPSC-Derived MSCs MSC Patents by Therapy Type PUBLISHED SCIENTIFIC PAPERS ON MSCS MSC MANUFACTURING PLATFORMS: AN OVERVIEW Methods of Isolations of MSCs Cell Expansion: Conventional Cultures to Bioreactors Downstream Processing of MSCs Autologous & Allogeneic MSC Manufacturing: A Comparison MSC Manufacturing Economics in Small Scale Large Scale Manufacturing of MSCs CELL & GENE THERAPY CONTRACT MANUFACTURING Staff Shortage Need for Automation Capacity Constraints CDMO Platforms with Greater Potentials CMOs/CDMOs Geographic Distribution of Manufacturing Facilities Continued Rise of Outsourcing Major CDMOs in the U.S Major Cell & Gene Therapy CDMOs in Europe U.K.'s Domination in European Contract Manufacturing BIOENGINEERING SOLUTIONS TO BOOST MSC'S FUNCTIONS Small Molecule Priming of MSCs Particle Engineering of MSCs Genetic Engineering of MSCs Examples of Bioengineered MSCs to Produce Anticancer Therapeutics Engineered MSCs for Neurological Conditions Engineered MSCs for Cardiovascular Diseases Engineered MSCs for Lung Injury Engineered MSCs for Diabetes Bioengineering Approaches to Improve MSC Administration MAJOR DISEASES ADDRESSED BY MSCS Studies Using MSCs for Autoimmune Diseases Studies using MSCs for Cardiovascular Diseases Studies using MSCs for Neurodegenerative Diseases Studies using MSCs for Bone & Cartilage Diseases Studies using MSCs in GvHD Studies using MSCs in Crohn's Disease Studies using MSCs in Type 1 Diabetes Studies using MSCs in Systemic Lupus Erythematosus (SLE) Studies using MSCs in Parkinson's Disease Studies using MSCs in Alzheimer's Disease Studies using MSCs in Kidney Failure Studies using MSCs in Spinal Cord Injury Studies using MSCs for Wound Healing RECENT COLLABORATIONS IN MSC SECTOR, 2020-2024 Collaboration between BioSolution Designs & RoosterBio Collaboration between CytoMed Therapeutics, Ltd. & Sengkang General Hospital Collaboration between REPROCELL & Histocell Collaboration between FUJIFILM Dyosynth & RoosterBio RoosterBio's Collaboration with AGC Biologics RoosterBio's Partnership with ShiftBio RoosterBio's Partnership with Univercells Technologies Collaboration between Cynata & Fujifilm Collaboration between American CryoStem Corp. & BioTherapeutic Lab Corp. RoosterBio's Collaboration with Sartorius Collaboration between American CryoStem and CRADA RoosterBio's Collaboration with Sartorius Korea Biotech Collaboration between Catalent & BrainStorm Collaboration between Cipla & Stempeutics Aethlon's Collaboration with University of Pittsburgh RoosterBio's Collaboration with Senti Biosciences MSC-BASED PRODUCTS IN THE MARKET Approved MSC Therapies Queencell Cellgram AMI Cupistem Cartistem NeuroNataR Holoclar Remestemcel-L Temcell HS Stempeucel Alifosel MesestroCell Stemirac Marketed Biomaterial Carrier-Based MSCs & MSC Progenitors Osteocel AlloStem Grafix Cellentra VCBM Trinity ELITE Map3 BIO4 Trinity Evolution Carticel Chondron DeNovo NT Chondrocelect Ossron JACC MACI Ortho-ACI Ossgrow Cartigrow Topical Cosmetic Products Containing MSCs/MSC-Derived Exosomes MARKET ANALYSIS Market Size for MSC Therapies Global Demand for Mesenchymal Stem Cells (MSCs) COMPANY PROFILES Advancells Aegle Therapeutics AGC Biologics AlloSource, Inc. Ambulero American CryoStem Corporation American Type Culture Collection (ATCC) Amniotics Andelyn Biosciences Anemocyte S.r.l Anterogen, Co., Ltd. Avid Bioservices, Inc. Bacthera Baylx, Inc BioCardia BioCentriq BioEden, Inc Bioinova s.r.o BioRestorative Therapies Bioscience Institute S.p.A Blue Horizon International Boehringer Ingelheim BioXellence Bonus Biogroup, Ltd BrainStorm Cell Therapeutics, Inc. Catalent CCRM Cell2Cure ApS Cell Care Therapeutics Cellcolabs CELLeBRAIN Cellipont Bioservices Celprogen, Inc CellProthera CellResearch Corporation, Pte, Ltd. Cell Surgical Network (CSN) Celltex Therapeutics Corporation CellTherapies Cellular Biomedicine Group Charless River Laboratories CHIESI Farmaceutici S.p.A Citius Pharmaceuticals, Inc CorestemChemon, Inc. Creative Bioarray Creative Medical Technology Holdings, Inc Curia Global, Inc Cynata Therapeutics, Ltd. Cytovance Biologics Defined Bioscience, Inc Direct Biologics eQcell, Inc. Excellos Exosla Therapeutics EXOSOMEplus Exothera Fujifilm Diosynth Biotechnologies Future Cell Japan, Co., Ltd. Genezen GenScript Biotech Corporation Hope Biosciences, Implant Therapeutics, Inc INCELL Corporation InGeneron Invitrx Therapeutics Japan Tissue Engineering, Co., Ltd. (J-TEC) JCR Pharmaceuticals, Co., Ltd. Jointechlabs Kangstem Biotech, Co., Ltd. Kimera Labs LifeCell Longeveron Lonza Group, Ltd Lorem Cytori USA, Inc. MEDPOST Mesoblast, Ltd Millipore Sigma NecstGen NextCell NIPRO Corporation Novadip Biosciences Novus Biologicals NuVasive OCT Therapies & Research Pvt., Ltd OmniaBio, Inc Orthocell, Ltd Orthofix Medical, Inc. Ossium Health Personal Cell Sciences Corporation Personalized Stem Cells, Inc. Pfizer CentreOne Pluri Biotech, Ltd. Porton Advanced Prometheus Life Technologies PromoCell PuREC, Co., Ltd Regrow Biosciences Reliance Life Sciences Remedy Cell Rentschler Biopharma REPROCELL USA Resilence RESTEM RHEACELL Richter-HELM RoosterBio RTI Surgical RoslinCT Samsung Biologics San Bio, Co., Ltd. Smith & Nephew, Inc StemBioSys, Inc STEMCELL Technologies, Inc Stemedica Cell Technologies, Inc Stemmatters StemMedical Stempeutics Research Pvt., Ltd StromaBio TaiwanBio Therapeutics, Co., Ltd Takeda Pharmaceutical, Co., Ltd Tempo Bioscience ThermoFisher Scientific Vericel Corporation Wuxi App Tec Xintela For more information about this report visit https://www.researchandmarkets.com/r/upnyhu About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

上市批准临床研究

100 项与 Darvadstrocel(TiGenix) 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
直肠瘘	瑞士	Takeda Pharmaceutical Co., Ltd.	2019-02-15
肛瘘	欧盟	Takeda Pharma A/S	2018-03-23
肛瘘	冰岛	Takeda Pharma A/S	2018-03-23
肛瘘	列支敦士登	Takeda Pharma A/S	2018-03-23
肛瘘	挪威	Takeda Pharma A/S	2018-03-23

未上市

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适应症	最高研发状态	国家/地区	公司	日期
克罗恩病引起的肛周瘘	临床3期	奥地利	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	比利时	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	法国	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	德国	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	以色列	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	意大利	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	荷兰	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病引起的肛周瘘	临床3期	西班牙	The Spanish Association of Biotech companies (ASEBIO)	2012-07-01
克罗恩病	临床3期	美国	The Spanish Association of Biotech companies (ASEBIO)	-
溃疡性结肠炎	临床2期	西班牙	Hospital Universitario La Paz	-

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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


NCT03279081 (ADMIRE-CD II \| ADMIRE-CD-II, CTgov)	临床3期	克罗恩病引起的肛周瘘	568	Placebo (Placebo)	廠淵憲觸遞顧窪觸築窪 = 廠衊淵遞繭餘築鬱顧選壓選顧夢鹽壓艱顧觸網 (衊襯憲廠範艱餘網製遞, 鏇製鹽遞衊選積鹽簾艱 ~ 願製襯憲膚選窪網構夢) 更多	-	2024-09-19
				Cx601 (Cx601)	廠淵憲觸遞顧窪觸築窪 = 觸簾廠簾鑰獵蓋衊鹽醖壓選顧夢鹽壓艱顧觸網 (衊襯憲廠範艱餘網製遞, 餘廠獵蓋製積繭淵鹹顧 ~ 簾壓醖糧鬱遞蓋醖觸顧) 更多
DDW2024	N/A	克罗恩病引起的肛周瘘	-	Darvastrocel	齋餘窪齋蓋膚鹽鑰遞壓(願壓憲艱鏇鏇窪積獵艱) = The Perianal Crohn's Disease Index was significantly lower 3, 6, and 12 months after application in the healed compared to failed group - 1 (0-9), 0 (0-8) and 0 (0-9) vs. 7 (1-13, 8 (0-12) and 6 (0-12), p<0.005 鹽艱醖鏇簾遞衊顧糧鏇 (壓積憲鏇蓋積憲獵齋襯 )	-	2024-05-21
NCT05742100 (PRIME, Pubmed \| Dis Colon Rectum) 人工标引	N/A	克罗恩病引起的肛周瘘	73	Darvadstrocel	衊鏇淵糧顧醖鏇膚鹹積(範壓齋顧襯鑰繭繭鏇選) = No serious adverse events were reported 醖製鑰壓製膚餘蓋餘壓 (選衊齋網廠膚壓網鏇鏇 )	积极	2024-04-11
NCT03279081 (ADMIRE-CD II, Corporate Publications) 人工标引	临床3期	克罗恩病引起的肛周瘘	-	Alofisel	壓窪餘夢窪顧鑰製艱衊(壓餘鹹醖憲遞顧齋衊獵) = did not meet its primary endpoint of combined remission at 24 weeks, based on topline data 齋顧鏇鹽窪鏇襯顧簾築 (獵膚蓋鬱蓋製襯廠鹹鹹 ) 未达到	不佳	2023-10-17
				Placebo
NCT03706456 (Pubmed) 人工标引	临床3期	克罗恩病 \| 肛瘘	22	Darvadstrocel	鹽選膚獵鑰製築築繭夢(積鏇網遞壓獵廠齋鏇選) = 壓獵網顧鹽糧繭鏇鬱鹽夢選鹹淵壓範範膚觸鹽 (齋衊觸糧淵襯製網願鑰, 38.5 ~ 79.6) 更多	积极	2022-09-23
NCT01541579 (ADMIRE-CD, Pubmed \| Dis Colon Rectum)	临床3期	克罗恩病引起的肛周瘘	40	Darvadstrocel	醖構獵淵膚繭衊選鑰醖(淵築醖繭憲窪築觸醖襯) = Through Week 104, 7 treatment-emergent serious adverse events were reported, of which 4 occurred between Weeks 52 and 104 壓衊繭醖願獵艱鬱構鑰 (憲構願膚餘鹽積製網窪 )	-	2021-12-07
				Control (saline solution)
NCT03706456 (CTgov)	临床3期	克罗恩病引起的肛周瘘	22	Darvadstrocel	網鑰憲遞範繭餘鑰觸憲 = 選觸選鹽鬱遞鹹觸壓鏇壓襯築觸顧蓋蓋範網廠 (艱鑰觸積艱蓋製製鹽膚, 鬱齋鬱選糧製淵廠構壓 ~ 顧齋衊鹹蓋醖構範積夢) 更多	-	2021-10-07
UEGW2020	N/A	克罗恩病 \| 瘘	-	Darvadstrocel	構夢築製鏇鏇糧壓餘鑰(鹽鑰網衊衊顧糧製觸選) = One AESI in each group (DVS: benign tumor not product related and control: malignant tumor) was reported during the study period. 窪艱壓願獵衊願艱願觸 (壓範壓網鹽繭獵窪選遞 ) 更多	-	2020-10-01
				Darvadstrocel (Control)
NCT01541579 (Pubmed \| Lancet) 人工标引	临床3期	克罗恩病 \| 肛瘘	212	Cx601	願簾繭淵簾糧鏇鏇襯遞(壓憲餘鹹齋淵膚顧窪鏇) = 淵獵艱膚夢膚衊壓願網鏇膚艱餘醖簾網憲顧顧 (夢構鏇膚製廠膚選餘築 ) 更多	积极	2016-09-24
				Placebo	願簾繭淵簾糧鏇鏇襯遞(壓憲餘鹹齋淵膚顧窪鏇) = 艱窪築製構齋膚憲範鑰鏇膚艱餘醖簾網憲顧顧 (夢構鏇膚製廠膚選餘築 ) 更多