Examination of effectiveness of combination therapy of periodontal tissue regeneration drug, Regroth, and carbonate apatite, Cytrans Granules, for periodontal tissue regenaration - Study on combination therapy of Regroth and Cytrans Granules for periodontal tissue regeneration

开始日期2019-11-01

申办/合作机构

The University of Tokushima

JPRN-jRCTs051190045 / CompletedN/AIIT

The clinical study to evaluate the safety and efficacy of combination therapy of REGROTH and Cytrans Granules for periodontitis patients.

开始日期2019-08-27

申办/合作机构-

100 项与曲弗明相关的临床结果

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100 项与曲弗明相关的转化医学

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100 项与曲弗明相关的专利（医药）

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1,179

项与曲弗明相关的文献（医药）

2025-01-01·Colloids and Surfaces B: Biointerfaces

Liposomal nano-encapsulation of bFGF combined with injectable BSA hydrogel for efficient burn wound healing

Article

作者: Tao, Shanhui ; Wang, Hong ; Li, Shijun ; Li, Yang ; Tu, Yuhan ; Ning, Yangyang ; Li, Bin ; Yao, Zhiang ; He, Huacheng ; Yang, Wenjing ; Li, Xiaofen

Rapid and scar-free healing of burn wounds is an urgent clinical issue. Basic fibroblast growth factor (bFGF) has been proven to promote the healing of burn wounds by accelerating ECM remodeling and angiogenesis. However, exudates from burn wounds can accelerate bFGF degradation, thereby affecting its bioactivity. This study proposes an effective protection strategy for bFGF that involves encapsulating bFGF in nanoliposomes (bFGF-NLip) and then incorporating bFGF-NLip into a bovine serum albumin (BSA) hydrogel. This hybrid hydrogel system (bFGF-NLip@B) could maintain the activity of bFGF, achieve sustained release, and allow phospholipids and cholesterol to penetrate the skin, thereby enabling bFGF to function in the dermis. The experimental results showed that the hydrogel was injectable with good mechanical properties and biocompatibility. In a mouse scald wound model, owing to the sustained release of bFGF and skin permeation function of the nanoliposomes, the hydrogel promoted granulation formation, collagen deposition, vascular regeneration, and re-epithelialisation, ultimately accelerating wound healing. In addition, the hydrogel effectively inhibited scar formation. This system provides novel insights into the delivery of bFGF and scar-free healing of burn wounds.

2024-12-01·Journal of Controlled Release

Drug conjugates crosslinked bioresponsive hydrogel for combination therapy of diabetic wound

Article

作者: Zheng, Manhui ; Wu, Jiang ; Song, Wenxiang ; Zhang, Miao ; Lin, Hanxuan ; Huang, Yueping ; Huang, Peipei ; He, Huacheng

Basic fibroblast growth factor (bFGF) has proved to be effective for wound healing, yet its effectiveness is extremely retarded in diabetic wounds due to the severe oxidative stress in wound beds. To solve this issue, herein a novel combination therapy of bFGF and N-acetylcysteine (NAC, antioxidant) was devised for improved diabetic wound repair. To avoid rapid loss of both drugs in the wound beds, a bioresponsive hydrogel (bFGF-HSPP-NAC) was engineered by incorporating bFGF and NAC into polymer-drug conjugates (HSPP) via thiol-disulfide exchange reactions. In response to oxidative stress (e.g., reactive oxygen species), the disulfide bonds (SS) within the hydrogel are broken into thiol groups (-S-H), thereby promoting hydrogel degradation and enabling controlled drug release. Initially, NAC is released to scavenge free radicals and ameliorate oxidative damage. Subsequently, bFGF is released to expedite tissue regeneration. This combinatorial strategy is tailored to the specific characteristics of the wound microenvironment at various stages of diabetic wound healing, thereby achieving therapeutic efficacy. The results indicate that the bFGF-HSPP-NAC hydrogel markedly enhances re-epithelialization, collagen deposition, hair follicle regeneration, and neovascularization. In conclusion, the bioresponsive bFGF-HSPP-NAC hydrogel demonstrates significant potential for application in combinatorial therapeutic approaches for diabetic wound healing.

2024-12-01·Contemporary Clinical Trials Communications

Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study

Article

作者: Ogawa, Takenori ; Kohyama, Keishi ; Suzuki, Kodai ; Kato, Hisakazu ; Miyake, Takahito ; Okada, Hideshi ; Okuda, Hiroshi ; Tomita, Hiroyuki ; Yasue, Yuji ; Kamidani, Ryo ; Shibata, Hirofumi ; Ishihara, Takuma

Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.

项与曲弗明相关的新闻（医药）

2024-11-07

·药事纵横

诱导多能干细胞衍生间充质干细胞疗法的研究进展及创新策略（一）

前言：间充质干细胞治疗的有效性与安全性已在多种疾病中得到证实。然而成体来源的间充质干细胞其体外扩增能力有限性、分离细胞的高异质性导致的临床结果的不稳定性等问题亟待解决。将iPSC通过特定实验路线诱导分化为iPSC衍生的间充质样MSC（iPSC-MSC），是最有潜力替代成体MSC的产品。许多研究证明iPSC可以通过多种分化策略获得iPSC-MSC，且经研究表明iPSC-MSC与成体MSC相比，其增殖能力、免疫调节能力、生物学效能等特点均优于成体MSC或与之相当。笔者试图通过检索相关文献资料，从iPSC-MSC制备的方法学研究、iMSC产品在不同疾病模型中的应用、临床级iPSC衍生细胞制品的最新研究进展以及新一代的iPSC衍生产品的开发策略等四个方面，与广大读者探讨此类细胞治疗产品的开发前景，抛砖引玉，以期展开对类似管线的开发前景的讨论，从而丰富产品开发思路。再生医学和细胞治疗已成为当今世界各国先进生物医疗技术关注的焦点，其中间充质干细胞（Mesenchymal stem cell, MSC）疗法潜力无限，已被证明在多种疾病的临床试验研究中具备安全性和有效性，广受关注。MSC属于成体多能干细胞，因其多向分化潜能高、免疫原性低及伦理问题少和来源广泛等特点，一直作为干细胞研究的重要方向[1]。MSC具有免疫调节、抗炎、支持造血功能、组织修复等功能特性[2]，可应用于自身免疫性疾病如红斑狼疮、炎性疾病如骨关节炎、衰老相关疾病、感染性疾病的治疗[3]。然而由于不同的MSC细胞来源、供体情况不同、培养体系差异等造成的细胞异质性、体外扩增能力的有限性、分离提取的难度与局限性等[4]，使得MSC细胞疗法在临床应用方面存在一些限制和效果的不稳定[5]。由iPSC获得iPSC-MSC的方法学研究进展笔者汇总了目前市面上的主流iPSC衍生MSC（iMSC）的制备方法[6]。分化方向大致可归类为三个方面，主流分化策略包括：MSC培养基替换诱导法、信号通路调节诱导法及拟胚体法等[7]。在下文中，对每种报道的研究方案使用的关键物料与方法细节进行了详细描述，各项研究也对衍生的iMSC进行了细胞表面标志物与多向分化潜能的评估，同时也针对每种方案的整体分化时间做了统计，以期找到一种高效且安全的可用于工业化生产的分化方案。（1）MSC培养基替换诱导法通过将iPSC培养基更换为MSC培养体系，能够诱导iPSC的自发分化，起到对细胞的诱导和筛选作用。MSC基础培养基成分包括高/低糖DMEM、KO-DMEM（特定成分敲除的DMEM）、DMEM-F12和α-MEM等，同时配合加入FBS、KOSR、L-谷氨酰胺、P/S、非必需氨基酸和FGF等。 Kang[8]等人报道，将iPSC培养基直接替换为含有10% FBS的DMEM培养基作用两周，传代后在预包被培养皿中对细胞持续传代，可获得成纤维细胞形态的iMSC细胞[9]。类似的诱导条件，使用α-MEM培养基[20]也能够获得。利用本法的整体诱导效率较低，如获得合格表型的iMSC（高表达 CD73、CD44、CD105、CD90；低表达CD19、CD34、CD45、HLA-DR等），且具备三系分化能力[10]，时间都要长达30-50天。（2）信号通路调节剂诱导iMSC形成通路抑制剂法是iPSCs诱导MSCs的一类常用方法，可快速高效的将iPSC诱导至MSC细胞表型并具有间充质干细胞功能。用于iPSC-MSCs诱导的抑制剂包括SB203580（p38-MAPK抑制剂）、SB431542（TGF-β抑制剂）、CHIR（GSK3抑制剂）、β-巯基乙醇、b-FGF等。 -SB203580 SB203580是一种吡啶咪唑类p38 MAPK抑制剂，对GAK、CK1、RIP2、c-Raf 和 GSK3等激酶也有抑制活性。p38-MAPK途径可促进MSC分化为表皮样细胞[11]，还可以抑制IL-2介导的T细胞增殖作用，在体内参与多种炎症反应或诱导细胞自噬。有文章报道SB203580能够促进iPSC细胞向中胚层表型的转化[12]，通过将iPSC悬浮形成拟胚体（EB），并在培养体系中加入一定浓度SB203580诱导拟胚体，将诱导后的拟胚体贴壁培养传代，28天后获得表面标志物合格的iMSC细胞，且传代20代后核型完整且细胞未衰老。 -SB431542 SB431542是TGF-β信号通路抑制剂，TGF信号通路是维持干细胞多能性的主要信号通路，抑制TGF通路可以诱导ESC和iPSC分化为MSC或神经元细胞[13]。Glaeser等人使用20 μM的SB431542经10-14天将ESC分步诱导为神经嵴细胞，再转换为有血清培养体系将神经嵴细胞向MSC样细胞转化[14]。Lee和Sun[15]等人在整个iMSC诱导过程中均加入10 μM SB431542，传代若干次后均获得具有三系分化能力的iMSC细胞系。不同研究者使用的SB431542作用浓度从1 μM向20 μM不等[16]，对iMSC的诱导效率未见明显差异。 -CHIR-99021 CHIR-99021是一种高度特异的糖原合成酶激酶-3（GSK-3）抑制剂，被证明可以促进BALB/c小鼠ES细胞的自我更新并维持其多能性。CHIR-99021涉及包括Wnt/β-catenin、TGF-β、Nodal和MAPK等多种信号通路[17]。不同浓度的CHIR99021常与 SB431542联合应用于iMSC的诱导分化。Harada等人[18]使用10 μM SB431542＋1 μM CHIR99021的化合物组合，按iPSC-神经嵴细胞-MSC样细胞的路线在21天左右成功诱导出间充质表型细胞。Winston等人[19]则使用4 μM SB431542＋4 μM CHIR99021＋10 ng/mL β-FGF在25天左右获得了iMSC。信号通路调节剂的加入与MSC培养基直接转换相比，诱导iMSC成熟的效率更高，整体分化时间被有效缩短，且获得的细胞无论从表型、三系分化能力及基因组表达方面，均与原代MSC细胞无明显差异[20]。 -β-巯基乙醇 β-巯基乙醇也是iMSC诱导过程中的常用添加物。Liang、McGrath、Hua和Lim等人，分别在iPSC培养体系中加入了浓度不同的β-巯基乙醇（终浓度分别为55 uM，0.1 mM，110mM[21]），30天左右获得成纤维样的iMSC细胞，经鉴定细胞表面标志物与三系分化能力与BM-MSC相似。（3）拟胚体法通过拟胚体（EB）介导的iMSC分化路径，能够在有限的培养体积中收获更多的目的细胞，有利于工业化和成本控制。然而培养过程整体需要的时间较长，且产生的细胞存在一定的异质性。研究者们通常在拟胚体形成及iMSC爬出阶段，在培养体系中加入化合物通路调节剂，以提高细胞向iMSC的富集效率。 Chen YS使用含有20% KOSR及0.1 μg/mL bFGF的DMEM-F12培养基，将iPSC悬浮培养形成EB，之后体系中加入10 μM浓度的SB431542以促进细胞爬出，接着经细胞传代获得iMSC [22]。Zhou等[23]开发了一种在生物反应器中大规模扩增胚胎干细胞的方法，将ESC悬浮培养后获得大量EB，接着使用含有KOSR的体系诱导EB分化，进一步诱导EB爬出，获得ES-MSC。研究者还进一步优化诱导体系，开发了诱导分化的新配方，在体系中添加一定浓度的b-FGF与TGFβ-1促进ES-MSC的爬出与成熟[24]。另外，包括Activin A，VEGF，BMP4，RA[25]等细胞因子也应用于经拟胚体分化的诱导过程中，分化天数在20-30天时间不等。由于篇幅所限，在下一篇讨论中，我们将对iMSC产品在不同疾病模型中的应用、临床级iPSC衍生细胞制品的最新研究进展以及新一代的iPSC衍生产品的开发策略这些方面进行进一步的探讨，笔者期待各位读者的反馈与进一步交流。 [1] A. Leyendecker, Jr., C.C.G. Pinheiro, M.T. Amano, D.F. Bueno, The Use of Human Mesenchymal Stem Cells as Therapeutic Agents for the in vivo Treatment of Immune-Related Diseases: A Systematic Review, Front Immunol 9 (2018) 2056. [2] M. Arabpour, A. Saghazadeh, N. Rezaei, Anti-inflammatory and M2 macrophage polarization-promoting effect of mesenchymal stem cell-derived exosomes, Int Immunopharmacol 97 (2021) 107823. [3] G. Guo, Z. Tan, Y. Liu, F. Shi, J. She, The therapeutic potential of stem cell-derived exosomes in the ulcerative colitis and colorectal cancer, Stem Cell Res Ther 13(1) (2022) 138. [4] M. Miura, Y. Miura, H.M. Padilla-Nash, A.A. Molinolo, B. Fu, V. Patel, B.M. Seo, W. Sonoyama, J.J. Zheng, C.C. Baker, W. Chen, T. Ried, S. Shi, Accumulated chromosomal instability in murine bone marrow mesenchymal stem cells leads to malignant transformation, Stem Cells 24(4) (2006) 1095-103. [5] W.J. Rombouts, R.E. Ploemacher, Primary murine MSC show highly efficient homing to the bone marrow but lose homing ability following culture, Leukemia 17(1) (2003) 160-70. [6] A. Abdal Dayem, S.B. Lee, K. Kim, K.M. Lim, T.I. Jeon, J. Seok, A.S. Cho, Production of Mesenchymal Stem Cells Through Stem Cell Reprogramming, Int J Mol Sci 20(8) (2019). [7] V. Dupuis, E. Oltra, Methods to produce induced pluripotent stem cell-derived mesenchymal stem cells: Mesenchymal stem cells from induced pluripotent stem cells, World J Stem Cells 13(8) (2021) 1094-1111. [8] R. Kang, Y. Zhou, S. Tan, G. Zhou, L. Aagaard, L. Xie, C. Bunger, L. Bolund, Y. Luo, Mesenchymal stem cells derived from human induced pluripotent stem cells retain adequate osteogenicity and chondrogenicity but less adipogenicity, Stem Cell Res Ther 6(1) (2015) 144. [9] J. Zhang, J. Guan, X. Niu, G. Hu, S. Guo, Q. Li, Z. Xie, C. Zhang, Y. Wang, Exosomes released from human induced pluripotent stem cells-derived MSCs facilitate cutaneous wound healing by promoting collagen synthesis and angiogenesis, Journal of Translational Medicine 13(1) (2015). [10] M. Arakura, S.Y. Lee, T. Fukui, K. Oe, S. Takahara, T. Matsumoto, S. Hayashi, T. Matsushita, R. Kuroda, T. Niikura, Endochondral Bone Tissue Engineering Using Human Induced Pluripotent Stem Cells, Tissue Engineering Part A 28(3-4) (2022) 184-195. [11] S. Hu, L. Zhu, Y. Song, X. Zhao, Q. Chen, Y. Pan, J. Zhang, Y. Bai, H. Zhang, C. Shao, Radiation-induced abscopal reproductive effect is driven by TNF-α/p38 MAPK/Rac1 axis in Sertoli cells, Theranostics 11(12) (2021) 5742-5758. [12] J. Zhang, M. Chen, J. Liao, C. Chang, Y. Liu, A.A. Padhiar, Y. Zhou, G. Zhou, Induced Pluripotent Stem Cell-Derived Mesenchymal Stem Cells Hold Lower Heterogeneity and Great Promise in Biological Research and Clinical Applications, Frontiers in Cell and Developmental Biology 9 (2021). [13] Tanaka, Transforming growth factor β signaling inhibitor, SB-431542, induces maturation of dendritic cells and enhances anti-tumor activity, Oncology Reports 24(6) (2010). [14] J.D. Glaeser, X. Bao, G. Kaneda, P. Avalos, P. Behrens, K. Salehi, X. Da, A. Chen, C. Castaneda, P. Nakielski, W. Jiang, W. Tawackoli, D. Sheyn, iPSC-neural crest derived cells embedded in 3D printable bio-ink promote cranial bone defect repair, Scientific Reports 12(1) (2022). [15] Y.S. Chen, R.A. Pelekanos, R.L. Ellis, R. Horne, E.J. Wolvetang, N.M. Fisk, Small Molecule Mesengenic Induction of Human Induced Pluripotent Stem Cells to Generate Mesenchymal Stem/Stromal Cells, Stem Cells Translational Medicine 1(2) (2012) 83-95. [16] D. Pal, H. Blair, J. Parker, S. Hockney, M. Beckett, M. Singh, R. Tirtakusuma, R. Nelson, H. McNeill, S.H. Angel, A. Wilson, S. Nizami, S. Nakjang, P. Zhou, C. Schwab, P. Sinclair, L.J. Russell, J. Coxhead, C. Halsey, J.M. Allan, C.J. Harrison, A.V. Moorman, O. Heidenreich, J. Vormoor, hiPSC-derived bone marrow milieu identifies a clinically actionable driver of niche-mediated treatment resistance in leukemia, Cell Reports Medicine 3(8) (2022). [17] G.-B. Fu, W.-J. Huang, M. Zeng, X. Zhou, H.-P. Wu, C.-C. Liu, H. Wu, J. Weng, H.-D. Zhang, Y.-C. Cai, C. Ashton, M. Ding, D. Tang, B.-H. Zhang, Y. Gao, W.-F. Yu, B. Zhai, Z.-Y. He, H.-Y. Wang, H.-X. Yan, Expansion and differentiation of human hepatocyte-derived liver progenitor-like cells and their use for the study of hepatotropic pathogens, Cell Research 29(1) (2018) 8-22. [18] M. Sampaolesi, M. Fukuta, Y. Nakai, K. Kirino, M. Nakagawa, K. Sekiguchi, S. Nagata, Y. Matsumoto, T. Yamamoto, K. Umeda, T. Heike, N. Okumura, N. Koizumi, T. Sato, T. Nakahata, M. Saito, T. Otsuka, S. Kinoshita, M. Ueno, M. Ikeya, J. Toguchida, Derivation of Mesenchymal Stromal Cells from Pluripotent Stem Cells through a Neural Crest Lineage using Small Molecule Compounds with Defined Media, PLoS ONE 9(12) (2014). [19] T.S. Winston, K. Suddhapas, C. Wang, R. Ramos, P. Soman, Z. Ma, Serum-Free Manufacturing of Mesenchymal Stem Cell Tissue Rings Using Human-Induced Pluripotent Stem Cells, Stem Cells International 2019 (2019) 1-11. [20] M. Yoshimatsu, H. Ohnishi, C. Zhao, Y. Hayashi, F. Kuwata, S. Kaba, H. Okuyama, Y. Kawai, N. Hiwatashi, Y. Kishimoto, T. Sakamoto, M. Ikeya, K. Omori, In vivo regeneration of rat laryngeal cartilage with mesenchymal stem cells derived from human induced pluripotent stem cells via neural crest cells, Stem Cell Research 52 (2021). [21] S.W. Lim, K.W. Kim, B.M. Kim, Y.J. Shin, K. Luo, Y. Quan, S. Cui, E.J. Ko, B.H. Chung, C.W. Yang, Alleviation of renal ischemia/reperfusion injury by exosomes from induced pluripotent stem cell-derived mesenchymal stem cells, The Korean Journal of Internal Medicine 37(2) (2022) 411-424. [22] Y.S. Chen, R.A. Pelekanos, R.L. Ellis, R. Horne, E.J. Wolvetang, N.M. Fisk, Small molecule mesengenic induction of human induced pluripotent stem cells to generate mesenchymal stem/stromal cells, Stem cells translational medicine 1(2) (2012) 83-95. [23] X. Li, R. Ma, Q. Gu, L. Liang, L. Wang, Y. Zhang, X. Wang, X. Liu, Z. Li, J. Fang, J. Wu, Y. Wang, W. Li, B. Hu, L. Wang, Q. Zhou, J. Hao, A fully defined static suspension culture system for large-scale human embryonic stem cell production, Cell death & disease 9(9) (2018) 892. [24] J. Wu, D. Song, Z. Li, B. Guo, Y. Xiao, W. Liu, L. Liang, C. Feng, T. Gao, Y. Chen, Y. Li, Z. Wang, J. Wen, S. Yang, P. Liu, L. Wang, Y. Wang, L. Peng, G.N. Stacey, Z. Hu, G. Feng, W. Li, Y. Huo, R. Jin, N. Shyh-Chang, Q. Zhou, L. Wang, B. Hu, H. Dai, J. Hao, Immunity-and-matrix-regulatory cells derived from human embryonic stem cells safely and effectively treat mouse lun [25] M. Karam, I. Younis, N.R. Elareer, S. Nasser, E.M. Abdelalim, Scalable Generation of Mesenchymal Stem Cells and Adipocytes from Human Pluripotent Stem Cells, Cells 9(3) (2020). 药事纵横征稿启事

细胞疗法免疫疗法

2024-07-25

·药融圈

珠海亿胜—滴眼液及吸入制剂CDMO/OEM | CMC-China博览会展商速递

企业简介专注于研发，生产和销售基因工程药物 rb-bFGF（重组牛碱性成纤维细胞生长因子）的生物制药企业,自1998年来已有六种基因工程新药在中国上市销售。公司主要产品主要应用于眼科及皮肤科处方药领域的创伤修复及疾病治疗，目前凭借在中国主要城市的43个销售推广办事处已成功覆盖超过中国12,000 家医院。生长因子领域创先者 • 全球首个上市的bFGF药品—贝复济® • 全球首个上市bFGF的眼用制剂—贝复舒® 坚实研发创新能力 • 拥有多项专利活性药物成分 • 眼科适应症为主的多元化研发储备两度稳固的市场地位稳固的市场地位 • 销售网络覆盖超过中国12,000家医院眼科、皮肤科生长因子类药品市占率第一研发平台 • rb-bFGF • rh-bFGF • 及其他生长因子用于体表创伤修复、眼表修复及神经损伤修复 • mAb(单克隆抗体) • bsAb(双特异性抗体) • scFv(单链抗体) • ADC(抗体偶联药物) • FDC(抗体片段偶联药物)等 • 眼用：滴眼液、眼用凝胶 • 外用：外用凝胶、外用溶液、冻干制剂 • 用于生产单剂量、不含防腐剂药物化妆品次抛产品核心优势尖端设备严格的无菌生产工艺，全自动一体化生产线拥有国内外领先的BFS高速生产线4条，其中：药品产线3条，化妆品产线1条总计年产能超3亿支。 30年丰富经验大肠杆菌发酵技术达领先水平目前公司的发酵、纯化产能：FGF-2系列某工程蛋白,采用多拷贝大肠杆菌表达体系原液蛋白发酵表达量达到350-420mg/，表达水平，原液蛋白纯度达到99.5%；抗VEGF单域抗体YS101工程蛋白，采用毕赤酵母表达体系，原液蛋白发酵表达量达到2000mg/L以上的表达水平。实力见证，荣获两项“国家科学技术进步二等奖” 国务院在2004年授予我司“国家科学技术进步二等奖”的荣誉称号，项目名称为“我国生物技术药物的质控标准、标准品的研究和制订”；2018年国务院再次授予我司“国家科学技术进步二等奖"的荣誉称号，项目名称为“我国原创细胞生长因子类蛋白药物关键技术突破、理论创新及产业化”。服务内容药品公司深耕眼科药物领域，拥有成熟的生产工艺和质量保障系统。自2018年正式启动药品CMO/CDMO业务，经过多年发展，现已成为国内眼科BFS系列产品CMO/CDMO代表性企业，与国内众多上市公司及知名企业建立长期稳定合作。化妆品药妆同源，科技护肤，依托自身强大的医药研发资源、多年的BFS技术实践基础及药品CMO/CDMO的经验，珠海亿胜生物制药有限公司成立全资子公司珠海亿胜生物技术有限公司，正式进军化妆品领域。合作模式 MAH联合申报 OEM订单生产定制研发、定制生产位 MAH/CMO：提供符合GMP条件的生产车间,可进行中试放大研究和验证生产,制剂成品可用于国内临床前研究、IND申报、临床试验及NDA的申报。支持国内1、2、3、4化药及生物类似药等申报,及注册咨询服务。 OEM：获批GMP证,可承接化药滴眼剂的商业化生产。公司现有强大的销售网络,可提供营销服务。 CDMO：大肠杆菌类生物制品定制研发与生产。 ↓↓扫描下方二维码免费报名

抗体药物偶联物引进/卖出申请上市上市批准

100 项与曲弗明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03362	曲弗明	D03	DB06244

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
牙周炎	日本	Kaken Pharmaceutical Co., Ltd.	2016-09-28
压疮	日本	Kaken Pharmaceutical Co., Ltd.	2001-04-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病足溃疡	临床前	捷克	Olympus Biotech Corp.	2010-11-01
糖尿病足溃疡	临床前	意大利	Olympus Biotech Corp.	2010-11-01
糖尿病足溃疡	临床前	法国	Olympus Biotech Corp.	2010-11-01
糖尿病足溃疡	临床前	匈牙利	Olympus Biotech Corp.	2010-11-01
牙槽骨质丢失	临床前	日本	Kaken Pharmaceutical Co., Ltd.	2008-08-01
牙周附着丢失	临床前	日本	Kaken Pharmaceutical Co., Ltd.	2008-08-01

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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


NCT01217476 (TRANS-North, CTgov)	临床3期	糖尿病足溃疡	207	Trafermin (Trafermin)	廠鑰艱夢膚齋餘簾選繭(製壓鏇繭餘製衊觸憲淵) = 鹹淵範鬱艱鬱壓繭襯膚艱蓋鏇築憲醖範獵範構 (鏇簾餘夢範廠廠範鏇鹽, 願夢膚範鹹鹽鏇繭網築 ~ 糧憲艱繭膚衊鬱範夢積) 更多	-	2014-08-05
				placebo (Placebo)	廠鑰艱夢膚齋餘簾選繭(製壓鏇繭餘製衊觸憲淵) = 廠鏇憲壓網壓糧簾願簾艱蓋鏇築憲醖範獵範構 (鏇簾餘夢範廠廠範鏇鹽, 鏇繭簾艱鬱選醖網壓願 ~ 網鏇願觸餘餘壓鹽蓋獵) 更多
NCT01217463 (TRANS-South, CTgov)	临床3期	糖尿病足溃疡	201	Trafermin 0.01% spray (Trafermin 0.01% Spray)	鹽襯鹽衊範簾構選廠鹹(簾艱築廠淵鹹範衊選鹽) = 夢遞築鑰顧鑰餘夢醖壓窪簾鹽製餘衊淵範夢製 (選顧觸齋積獵衊衊窪齋, 鏇繭醖遞醖網憲繭憲觸 ~ 廠觸鑰膚鹹餘襯壓網觸)	-	2014-08-05
				Trafermin 0.01% spray (Matching Placebo Spray)	鹽襯鹽衊範簾構選廠鹹(簾艱築廠淵鹹範衊選鹽) = 範壓製築鏇簾醖齋餘壓窪簾鹽製餘衊淵範夢製 (選顧觸齋積獵衊衊窪齋, 築壓選糧鬱淵廠繭網壓 ~ 廠鏇鏇築膚艱鏇艱醖願)
ARVO2003	N/A	腱鞘囊肿	-	Adenosine 10 µM	艱鹽鬱製夢醖憲衊糧膚(糧壓壓構夢築網範簾窪) = 憲醖淵網鬱築糧齋築觸繭網簾憲艱願獵繭遞積 (醖鑰廠艱蓋壓獵窪願鬱 )	-	2003-05-01
				Adenosine 100 µM	艱鹽鬱製夢醖憲衊糧膚(糧壓壓構夢築網範簾窪) = 壓衊簾網蓋顧襯繭製鹽繭網簾憲艱願獵繭遞積 (醖鑰廠艱蓋壓獵窪願鬱 )
ARVO2002	N/A	病理性新生血管	18	Medpor(R) soaked with bFGF	襯鑰鬱襯憲膚淵夢艱壓(觸構構鑰蓋齋夢憲顧遞) = 齋簾壓壓窪築顧鏇夢鑰範鹽餘積糧壓膚鏇鏇築 (醖餘鑰糧憲簾繭築廠鬱 )	积极	2002-12-01
				Basic Fibroblast Growth Factor	襯鑰鬱襯憲膚淵夢艱壓(觸構構鑰蓋齋夢憲顧遞) = 鏇壓顧顧淵襯顧襯鬱願範鹽餘積糧壓膚鏇鏇築 (醖餘鑰糧憲簾繭築廠鬱 )