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trastuzumab (BP 02 / BP02)

✓ Approved

Aurobindo Pharma Limited · ERBB2 · 单克隆抗体

什么是 trastuzumab？

trastuzumab 是一种单克隆抗体，由Aurobindo Pharma Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名BP 02, BP02
公司Aurobindo Pharma Limited
药物类别单克隆抗体, 抗体
分子靶点ERBB2, LRP1
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Aurobindo Pharma Limited

作用机制

分子靶点

trastuzumab 作用于 2 个分子靶点：

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
LRP1LDL receptor related protein 1 (LRP1A, A2MR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

trastuzumab 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancerBLA/NDA

相关研究文献

PubMedJACC. CardioOncology2026-09-10

Real-World Cardiotoxicity of Biosimilar versus Reference Trastuzumab in Early HER2-Positive Breast Cancer.

Jackson Inimfon I, Zhang Ning N, Sullivan Marija M, Zhao Hui H et al.

Trastuzumab has greatly improved outcomes in patients with human epidermal growth factor receptor 2-positive breast cancer. To reduce costs and increase access, biosimilar products were approved after trials demonstrated short-term safety similar to that of reference trastuzumab. However, real-world data on cardiac safety are limited. We evaluated the adoption of biosimilar trastuzumab and compared heart failure (HF) risk between users of reference and biosimilar trastuzumab. Patients aged ≥18 years with breast cancer who received trastuzumab from 2018 to 2024 were identified in the IQVIA PharMetrics Plus Closed Health Plan Claims database. Patients who underwent surgery within the first year after cancer diagnosis were selected as a proxy for early-stage disease. Healthcare Common Procedure Coding System Level II codes were used to identify reference and biosimilar trastuzumab use, and International Classification of Diseases codes were used to identify HF diagnoses. Patients with an HF diagnosis before breast cancer surgery were excluded. Multivariable cause-specific Cox proportional hazards regression was used to examine the association of reference vs biosimilar trastuzumab use with HF risk. Among 5,135 patients identified, 43.9% received reference trastuzumab. Use of biosimilar trastuzumab increased from 0% in 2018 to 71.3% in 2024 (P < 0.001). The overall rate of HF was 5.9% (5.5% among reference trastuzumab users vs 6.3% among biosimilar trastuzumab users; P = 0.26). In multivariable analysis, there was no statistically significant difference in HF risk between patients treated with biosimilar trastuzumab and those treated with reference trastuzumab (adjusted HR [aHR]: 1.16; 95% CI: 0.92-1.46). Patients with a Charlson Comorbidity Index score ≥2 had a higher risk of HF than those with a score of 0 (aHR: 1.52; 95% CI: 1.11-2.08). Compared with patients aged 18 to 54 years, those aged 65 to 74 years (aHR: 1.61; 95% CI: 1.19-2.19) and ≥75 years (aHR: 1.95; 95% CI: 1.29-2.96) had a higher risk of HF. As biosimilar trastuzumab use continues to increase, our findings provide reassurance regarding its cardiac safety in the management of early-stage human epidermal growth factor receptor 2 breast cancer. Additional studies with longer follow-up are needed to confirm these findings and evaluate long-term cardiac outcomes.

PMID 42720642
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PubMedFrontiers in pharmacology2026-09-10

Trastuzumab-TKI combination in HER2-Positive tumors: a FAERS-Based safety profile and multimodal analysis of Tanespimycin's role in enhancing targeting of the HSP90AA1-PI3K-Akt-mTOR axis.

Chen Xiao X, Han Xiao X, Zhang Yuanyuan Y, Cao Junming J et al.

This study addresses the safety profiles and molecular mechanisms of trastuzumab monotherapy and its combination with lapatinib, neratinib, and tucatinib for treating HER2-positive tumors. The research integrates a multi-platform approach, including data from the US Food and Drug Administration Adverse Event Reporting System (FAERS), network pharmacology, molecular docking, molecular dynamics simulations, and in vitro experiments. Specifically, 38,300 FAERS reports were screened, alongside a series of in silico modeling and laboratory assays to systematically evaluate drug safety and therapeutic mechanisms. Pharmacovigilance analysis revealed that trastuzumab monotherapy was associated with an elevated incidence of cardiac and tumor progression-related adverse events (AEs). Combination therapies showed longer adverse event latency periods. Network pharmacology identified HSP90AA1 as a pivotal therapeutic target, while molecular docking and 100-ns molecular dynamics simulations confirmed the stable binding of each drug to HSP90AA1. In vitro assays demonstrated that HSP90AA1 is significantly overexpressed in breast cancer, driving cell proliferation and invasion, and correlates with a poor prognosis. Furthermore, the triple regimen of trastuzumab, lapatinib, and tanespimycin significantly inhibited the PI3K/Akt/mTOR signaling pathway. This study establishes a novel framework for drug safety evaluation and provides a theoretical rationale for optimizing therapeutic strategies in HER2-positive tumors. These findings highlight the potential advantages of combination therapies regarding AE latency and elucidate the critical role of HSP90AA1.

PMID 42719185
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PubMedStem cells international2026-09-10

Mechanisms of Mesenchymal Stem Cell-Derived Exosomes in Dry Eye Disease: From Inflammation Pathways to Therapeutic Prospects.

Yi Jiahuan J, Lu Fangfang F, Tian Yale Y, Wang Yu Y et al.

Dry eye disease (DED) is a chronic ocular surface disorder triggered by tear film imbalance, in which inflammatory disruption of immune homeostasis constitutes the core pathological mechanism. Mesenchymal stem cell-derived exosomes (MSC-Exos) offer promising anti-inflammatory therapeutic potential through immune modulation, tissue repair, and their inherently low immunogenicity. This review elucidates MSC-Exos' molecular regulation of DED inflammation, demonstrating their suppression of the TLR4/NF-κB signaling axis, the IRAK1/TRAF6/NF-κB cascade reaction, the STAT3 transcriptional regulatory network, and the NLRP3 inflammasome activation pathway, while revealing a synergistic mechanism through which MSC-Exos ameliorate the ocular surface inflammatory microenvironment by modulating the Th17/Treg immune balance via the gut-eye axis and facilitating FBXW7-mediated ubiquitination degradation pathways. Despite this therapeutic potential, clinical translation is hampered by exosomal heterogeneity, difficulties in standardization, and suboptimal delivery efficiency and long-term efficacy. Future progress will require the integration of nanotechnology and gene editing to enhance therapeutic functionality, ultimately positioning MSC-Exos as precision biologics for DED.

PMID 42719581
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PubMedAAPS PharmSciTech2026-09-10

From Liquid to Gel: Multifunctional Stimuli-responsive Polymers for Targeted Oral Drug Delivery.

Mishra Manoj Kumar MK, Shukla Divaker D, Sharma Shalini S, Sharma Jyoti Nanda JN et al.

Oral drug delivery is the delivery method of choice, as it is non-invasive and patients will comply with the delivery method, but many contemporary therapeutics, such as poorly soluble, permeable, and unstable drugs, fail because of rapid gastrointestinal absorption, enzyme degradation, and non-targetability. The in-situ gelling systems are now considered paradigms that no longer exist as liquids; instead, they form a depot in the gastrointestinal tract and transform into a gel in response to physiological signals such as pH, ions, or enzymes. This review will discuss how these so-called smart polymers have developed over the years, starting as simple gel-forming systems and evolving into the multifunctional platforms that are also designed to have a pointed and sustained action. Next generation in situ gels combine bioadhesion, permeation enhancement, and active targeting ligands to overcome sequential barriers to delivery transit, permeability, stability, and cellular uptake. We critically assess the chemistry, mechanisms, formulation strategies, and therapeutic use of these systems, including gastro-retention and localized therapy, as well as oral delivery of biologics. Despite encouraging preclinical results, we touch on translational issues of scalability, manufacturing, and regulatory pathways. Multifunctional stimuli-responsive polymers, which actively traverse the gastrointestinal environment, are the future of oral drug delivery because they provide precision, bioavailability, and improved patient outcomes.

PMID 42717126
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PubMedAnnals of translational medicine2026-09-10

Individualized pharmacotherapy: background and development.

Jørgensen Jan Trøst JT, Westergaard Niels N

Most drug prescriptions are still based on empiricism and not on solid biological data, which often results in considerable patient variability and, sometimes, low patient benefits. Although variability in patient response to pharmacotherapy has long been recognized, only in recent decades have new molecule analytical methods provided insight into some of the causes, which are often related to somatic or germline genetic variations. Based on this insight, different predictive biomarker tests have been developed to optimize and individualize pharmacotherapy. These biomarker tests are classified as companion diagnostic (CDx) or pharmacogenetic (PGx) tests. In both the United States and Europe, CDx and PGx information is part of the regulatory drug labeling and is included in the Prescribing Information for the individual drugs and biologics. In the United States, this type of information is found in the labeling of more than 400 regulatory-approved drugs and biological products. Despite these measures and the documented clinical utility of CDx and PGx testing, clinical implementation is lagging, especially with regard to PGx. There are various reasons for the lack of testing, such as insufficient education and awareness among healthcare professionals, inadequate access to biomarker testing, regulatory hurdles, and insufficient reimbursements. Although progress has been made in recent years, further efforts are needed to fully realize the potential of individualized pharmacotherapy by integrating the use of predictive biomarkers into routine clinical practice.

PMID 42718847
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PubMedCrohn's & colitis 3602026-09-10

Colombian registry of inflammatory bowel disease in pediatrics.

Sarmiento Quintero Fernando F, Castañeda Figueroa Ana María AM, Mora Quintero Diana Victoria DV, Sánchez Franco Claudia Patricia CP et al.

Inflammatory bowel disease (IBD) has significantly increased over the past two decades. However, registries in Latin America remain scarce, prompting the creation of the Colombian pediatric IBD registry for patients under 18 years of age, designed as a continuous and periodically assessed database. A descriptive, longitudinal, ambispective, and multicenter observational study was conducted in children aged 0-18 years between January 1999 and December 2021. The analysis was performed based on the age of onset (Paris classification), with subdivisions for very early onset and phenotypes using the Pediatric IBD-classes algorithm. Data were collected in REDCap and analyzed with STATA 15.1. A total of 209 patients were included, 54.5% male. The median age at diagnosis was 12.3 years (IQR 8.5-14.6). Phenotype distribution included: 104 (53.06%) typical ulcerative colitis (TUC), 52 (26.53%) Crohn's disease (CD), 18 (9.18%) unclassifiable IBD (U-IBD), 11 (5.61%) colonic Crohn's disease (CCD), and 11 (5.61%) atypical ulcerative colitis (AUC). The median time to diagnosis was 6.6 months, and treatment began after a median of 11.2 days. Coffee-cultivation zone 39%. Extraintestinal manifestations were reported in 43.9% of cases. Initial treatments included mesalamine ± steroids (35.86%), immunomodulators ± steroids (32%), exclusive/partial enteral nutrition (11.41%), and biologics ± immunomodulators (20.65%), which increased to 57.7% during follow-up. Relapse occurred in 53.26% of patients, while 35.32% achieved remission. This registry highlights the increasing incidence of pediatric IBD in Latin America, providing valuable insights into clinical presentations, diagnostic delays, treatment strategies, and outcomes, while revealing regional and global disparities.

PMID 42719817
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