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更新于：2026-03-08
Mabpharm Ltd.
更新于：2026-03-08
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免疫系统疾病
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NCT07254325
Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of New Process CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects
NCT07246291
Randomized, Double-Blind, Parallel-Controlled, Single-Dose Pharmacokinetic, Safety, and Immunogenicity Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers
ChiCTR2500113979
Randomized, Double-Blind, Parallel-Controlled, Single-Dose Pharmacokinetic, Safety, and Immunogenicity Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers
100 项与 迈博药业有限公司 相关的临床结果
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2026-01-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Longitudinal profiling of cerebrospinal fluid N-glycome dynamics in glioblastoma patients treated with apatinib
Article
作者: Lin, Hao ; Xu, Jin ; Zhou, Xinli ; Ji, Xiaoyu ; Zheng, Chunguang ; Zhou, Chaoxin ; Wang, Xuekun ; Kong, Yiru ; Guo, Qingcheng ; Li, Zhixin ; Sun, Ziqiao ; Guo, Huaizu ; Zhang, Dapeng ; Liu, Tao
Glioblastoma (GBM) remains a therapeutically intractable central nervous system malignancy with limited treatment options. Apatinib, a selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, shows emerging potential in recurrent or refractory glioblastoma, yet its impact on the cerebrospinal fluid (CSF) glycome remains unexplored. In this pioneering longitudinal study, we characterize the N-glycome dynamics in paired CSF specimens from GBM patients pre- and post-apatinib treatment using hydrophilic interaction-based ultra performance liquid chromatography (HILIC-UPLC)-fluorescence mass spectrometry-based glycan profiling. Our results highlight potential alterations in specific glycoforms, particularly an increase in GalNAcβ1-4GlcNAc (LacdiNAc or LDN), core fucosylation(a modification catalyzed by α1,6-fucosyltransferase (Fut8), which transfers L-fucose from GDP-fucose to the innermost GlcNAc residue), and bisecting glycans(a β1,4-linked GlcNAc attached to the core β-mannose residue), a decrease in sialylation and biantennary glycans among treatment responders. These shifts correlate with attenuated immunosuppressive signatures, suggesting enhanced immunomodulation that may contribute to apatinib's therapeutic efficacy. This work uncovers the remodeling of the CSF glycome driven by apatinib, providing a novel molecular lens for understanding its anti-angiogenic/immune-modulating mechanisms and proposing CSF N-glycans as dynamic biomarkers for treatment efficacy in GBM.
2025-12-01International Journal of Pharmaceutics-X
High-concentration L-methionine as a potent antioxidant for oxidation resistance and stability enhancement in high-concentration antibody therapeutics
Article
作者: Guo, Yajun ; Mao, Dan ; Wang, Xuekun ; Zhang, Weitao ; Xu, Shuhai ; Liu, Tao ; Huang, Keyuan ; Zheng, Chunguang ; Sun, Ziqiao ; Han, Fubo ; Li, Jun ; Guo, Qingcheng ; Zhang, Dapeng ; Guo, Huaizu ; Hou, Sheng ; Shen, Xinyi ; Zhang, Xinyu ; Xu, Jin ; Dong, Taimin ; Qian, Weizhu ; Li, Zhixin ; Yu, Wei ; Dai, Jianxin ; Ni, Qiaoling ; Cao, Jiawei ; Ji, Lusha
The development of high-concentration monoclonal antibody (mAb) formulations for subcutaneous administration is faces critical stability challenges, particularly oxidation and aggregation, which compromise efficacy and safety. While antioxidants are commonly employed, existing studies predominantly focus on low concentrations, leaving the potential of high-concentration antioxidants underexplored. Here, we present the first systematic evaluation of high-concentration L-methionine (L-Met,>20 mM) as a novel antioxidant to address these limitations. Through accelerated stability testing coupled with multi-dimensional analytical techniques, we demonstrated that L-Met at concentrations exceeding 20 mM surpasses conventional antioxidants in mitigating oxidation and aggregation. Synergy with 200 mM trehalose further enhanced stability by reducing oxidative degradation and inhibiting protein aggregation. Comprehensive biophysical analyses confirmed no adverse effects, with some aspects showing improved outcomes in structural integrity, colloidal stability, and thermal behavior. The optimized formulation (25 mM L-Met +200 mM trehalose) also exhibited robust protection against light-induced degradation and broad applicability across therapeutic antibodies. This work pioneers a high-concentration antioxidant strategy, addressing a critical gap in mAb formulation science and offering a translatable solution for stabilizing next-generation high-concentration biologics.
2025-10-01JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY
Feasibility of Rapid Regulatory Differentiation of TNF Receptor 2-Fc Fusion Protein Products from Various Manufacturers in the Chinese Market Using a Novel Mass Spectrometry-Based Multi-attribute Method (MAM)
Article
作者: Guo, Yajun ; Fang, Xinxin ; Zhuang, Huangzhen ; Zheng, Chunguang ; Ji, Lusha ; Yu, Wei ; Li, Jun ; Chen, Xi ; Shao, Hong ; Wang, Fugui ; Nie, Aiying ; Qian, Weizhu ; Zhang, Dapeng ; Guo, Huaizu ; Song, Lankun ; Hou, Sheng ; Mao, Dan ; Gao, Tianyu ; Xu, Jin ; Pan, Zhiyuan ; Ren, Yule ; Dong, Shanshan ; Li, Zhixin ; Zhu, Weifan ; Guo, Qingcheng ; Liu, Tao ; Xu, Mengjiao ; Xu, Mingming
Ensuring the quality of pharmaceutical products, particularly for complex recombinant protein drugs such as TNF receptor 2-Fc fusion proteins (TNFR2-Fc, Etanercept), poses significant public health challenges. These products, including biosimilars and follow-on versions, exhibit intricate glycosylation patterns and heterogeneous post-translational modifications, complicating their analytical assessment. The Chinese market, hosting four different TNFR2-Fc products, presents a unique regulatory challenge for rapid differentiation and quality control. This study developed a novel mass spectrometry-based multiattribute method (MAM) to address this challenge, enabling simultaneous monitoring of multiple quality attributes and effective differentiation among products from various manufacturers. Conventional techniques initially indicated high purity across all products, but these methods provided limited capabilities for differentiation. The improved MAM approach, involving desialylation, partial deglycosylation, and digestion steps, minimizes heterogeneity and simplifies analysis. This method successfully indicates differences in primary amino acid sequences and specific quality attributes, allowing for a clear differentiation among manufacturers. Notably, products from manufacturers A and B, as well as C and D, despite their high similarity, could be differentiated by their O-glycan profiles. Further activity evaluations revealed that the products from manufacturers C and D exhibited lower binding and biological activity, potentially due to differences in primary amino acid sequences or disulfide bond mismatches. Additionally, all products demonstrated similar Fc-effector functions. In conclusion, this study underscores the variability among TNFR2-Fc products in the Chinese market and the necessity for robust regulatory oversight. The MAM method developed herein serves as a rapid, accurate, and technologically advanced platform for quality control with significant implications for regulatory authorities, healthcare providers, and patients in ensuring access to safe and effective TNFR2-Fc products.
100 项与 迈博药业有限公司 相关的药物交易
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管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
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