Aurobindo Pharma Limited · ERBB2 · Monoclonal Antibodies
trastuzumab is a monoclonal antibodies developed by Aurobindo Pharma Limited. It is approved for therapeutic indications via injectable (others) or intravenous (iv).
| Brand Names | BP 02, BP02 |
| Company | Aurobindo Pharma Limited |
| Drug Class | Monoclonal Antibodies, Antibody |
| Molecular Target | ERBB2, LRP1 |
| Route | Injectable (Others), Intravenous (IV) |
| Status | Approved |
trastuzumab acts on 2 molecular targets:
| ERBB2 | erb-b2 receptor tyrosine kinase 2 (NEU, CD340) |
| LRP1 | LDL receptor related protein 1 (LRP1A, A2MR) |
trastuzumab is developed for 2 unique indications across 1 therapeutic area.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Breast cancer | ✓ Approved |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Gastric cancer | BLA/NDA |
Bai Jia Qi Adam JQA, Wen Sherilyn S, Chen Shuang S, Xu Yihang Y et al.
Wang Yuan Y, Jin Lei L, Huan Xiao X, Chen Ran R et al.
Myasthenic crisis (MC) represents a life-threatening condition in patients with myasthenia gravis (MG). Despite a substantial reduction in in-hospital mortality for MC, full restoration of muscle strength and quality of life usually requires months or years. It remains unknown whether the sequential use of targeted biologics improves clinical outcomes in patients post-MC compared with the standard of care (SOC). We prospectively followed patients from MC through 6 months post-discharge between November 2018 and November 2025. We then stratified patients into subgroups according to the use of either biologics-based therapy (C5 inhibitors, FcRn antagonists, or rituximab) (BIO) or SOC. The primary endpoint was the Myasthenia Gravis Foundation of America-quantitative MG (MGFA-QMG) score at 6 months after discharge. Secondary outcomes included Myasthenia Gravis Activities of Daily Living (MG-ADL), steroid dose, immunosuppressant (IS) use, cumulative steroid exposure, minimal symptom expression (MSE), and residual symptom burden. At 6 months after discharge, the BIO group (n = 56) had a lower MGFA-QMG score than the SOC group (n = 56) (4.51 ± 4.03 vs 6.28 ± 4.72; P = 0.038). Meanwhile, the BIO group required a lower dose of oral corticosteroid (14.74 ± 10.24 vs 21.96 ± 12.87 mg/day; P = 0.004), lower cumulative steroid burden (158.13 ± 64.71 vs 209.24 ± 96.81 mg/day·month; P = 0.001), and had a lower proportion of IS use (47.3% vs 67.9%; P = 0.028). MSE was achieved in 56.86% in the BIO and 60.38% in the SOC group, respectively. Targeted biologics were associated with better objective muscle strength and reduced corticosteroid and IS use after MC, although no significant between-group difference was observed in MG-ADL. A substantial proportion of patients in both groups continued to have residual symptoms at 6 months.
Wu Guangyao G, Qin Xiaoxue X, Fathi Fatemeh F, Chen Xuhong X et al.
Bioanalytical platforms, such as biosensors and biochips, are widely used for detecting biomolecules including antibodies. Determining the conformation and orientation of antibodies captured by surface-immobilized recognition elements is essential for designing biosensors and biochips with improved performance. However, obtaining such structural information remains challenging because antibodies are located at buried solid/liquid interfaces that are difficult to characterize. Here, we investigated the binding interaction between Herceptin (trastuzumab), a therapeutic monoclonal antibody, and CH19, a HER2 mimotope peptide immobilized at a buried solid/liquid interface. Sum frequency generation (SFG) vibrational spectroscopy revealed specific binding of Herceptin to the surface-immobilized CH19 peptide, whereas no detectable interaction was observed for the non-target antibodies Cetuximab and Rituximab. By integrating SFG measurements with molecular dynamics (MD) simulations and one-exciton Hamiltonian spectral calculations, we determined the interfacial molecular structure of Herceptin and found that the antibody adopts a lying-down orientation on the CH19-functionalized surface. These combined experimental and computational results demonstrate that CH19-Herceptin recognition at the interface differs fundamentally from the corresponding interaction in solution, highlighting the unique influence of interfacial environment on antibody-antigen recognition. Our results support a surface-enabled multivalent binding model, in which multiple immobilized CH19 peptides interact with broader regions of Herceptin and generate a contact pattern distinct from that in solution. These results demonstrate that the combined SFG, MD, and spectral-calculation approach can determine the molecular structure of a full-length antibody at a buried interface, offering valuable insights for the rational design of biosensors, biochips, and other surface-based biorecognition analytical technologies.
Abudayah Alaa A AA
Mucin, a highly glycosylated macromolecular component of mucus, has traditionally been regarded as a biological barrier that restricts drug transport across mucosal surfaces. Growing evidence, however, has repositioned mucin as a functional and engineerable biomaterial with distinctive potential for advanced drug delivery. This review examines the evolution of mucin-based delivery systems from native mucin and bulk matrices to engineered hydrogels, hybrid materials, micro- and nanoparticles, and intrinsically glycosylated nanocarriers such as mucosomes. Particular emphasis is placed on the relationship between mucin molecular architecture and pharmaceutical functionality and on the engineering strategies used to control its material properties, including chemical modification, crosslinking, polymer hybridization, nanoscale assembly, and molecular programming. These approaches have progressively transformed mucin-based systems from passive drug reservoirs into environmentally responsive and increasingly programmable platforms capable of controlled release, molecular recognition, and on-demand therapeutic responses. Emerging applications in mucosal and ocular delivery, antimicrobial and biofilm therapy, biologics, and nucleic acid therapeutics further demonstrate the expanding pharmaceutical potential of mucin. Nevertheless, clinical translation remains constrained by source-dependent heterogeneity, variability in glycosylation and purification, batch-to-batch reproducibility, stability, sterilization, scalable manufacturing, and limited in vivo validation. Future progress will require better-defined mucin materials, standardized characterization and manufacturing, rigorous safety and efficacy assessment, and demonstration of clear therapeutic advantages over established delivery systems. Collectively, advances in mucin engineering, glycoengineering, nanotechnology, and molecular programming may enable the transition of mucin from a biological barrier component to a responsive, programmable, and clinically relevant platform for smart drug delivery.
Gu He H, Li Chunyan C, Liang Jie J, Tian Feng F et al.
The growing prevalence of mild-to-moderate ulcerative colitis (UC) among elderly individuals ( ≥60 years) poses unique clinical challenges due to age-related vulnerabilities, while real-world evidence on outpatient management and age-based differences remains limited. This multicenter cross-sectional study recruited 429 patients with mild-to-moderate UC from 47 inflammatory bowel disease centers. A Delphi-developed questionnaire was applied to assess clinical profiles and medication adherence. All statistical analyses were performed using R 4.5.0, with P-value < 0.05 set as the significance level. Older patients had a longer median disease duration (6.0 years vs. 4.0 years; P= 0.001) and a higher proportion with moderate disease activity (60.4% vs. 51.8%; P= 0.029) compared with non-older patients. Diagnostic efficiency, disease extent, and extraintestinal manifestations did not differ between groups. Use of 5-aminosalicylic acid (5-ASA) remained the first-line therapy in both groups, with lower corticosteroid use among older patients (8.8% vs. 16.2%; P= 0.035). Older patients reported higher satisfaction with 5-ASA across several care domains (P= 0.019). Medication adherence was similar across age groups, and adherence analysis identified switching to biologics (odds ratio [OR], 0.31; P= 0.001), 3-4 physician visits for diagnosis (OR, 0.60; P= 0.048), and greater long-term efficacy satisfaction (OR, 0.64; P= 0.049) were associated with better adherence. Older adults with mild-to-moderate UC demonstrate distinct clinical phenotypes and divergent treatment priorities. Timely therapeutic escalation, the diagnostic process, and perceived treatment effectiveness are closely associated with medication adherence. These findings highlight the need for age-adapted management strategies in elderly UC patients.
Thakur Purnima P, Gupta Manish M, Kant Lalit C LC, Mehta Priya P et al.
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is associated with a high incidence of brain metastases (BMs), particularly among young and heavily pretreated patients, with intracranial disease remaining a major determinant of survival and quality of life (QoL). Tucatinib, a HER2-selective tyrosine kinase inhibitor (TKI), combined with trastuzumab and capecitabine, has demonstrated significant progression-free survival (PFS) and overall survival (OS) benefit, including in patients with active BMs. We present the case reports of two patients, both younger than 50 years, with HER2-positive metastatic breast cancer and biologically aggressive disease who progressed on prior anti-HER2 therapy (trastuzumab, lapatinib, and ado-trastuzumab emtansine (Ujvira™) in Case 1 and trastuzumab in Case 2) with worsening central nervous system involvement. Both were subsequently treated with tucatinib-based combination therapy (Tukavo™) later in the treatment sequence, once it became available and affordable, and showed clinical and radiological improvement. Case 1 had improvement in right-sided limb weakness and speech with no further seizures and remained clinically stable for seven months, and Case 2 had complete resolution of headache and vomiting, with Eastern Cooperative Oncology Group (ECOG) performance status improving from 2 to 1. QoL was assessed clinically from symptoms and performance status rather than with a validated instrument. This real-world experience illustrates the potential benefit of tucatinib-based regimens in young patients with aggressive HER2-positive breast cancer and BMs, even when used later in the treatment sequence. These findings are consistent with pivotal trial data in a resource-limited, real-world setting.
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