北京若生智能科技有限公司
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trastuzumab (HS 022 / HS022 / anruize)

✓ Approved

BioRay Pharmaceutical · ERBB2 · 单克隆抗体

什么是 trastuzumab？

trastuzumab 是一种单克隆抗体，由BioRay Pharmaceutical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HS 022, HS022, anruize
公司BioRay Pharmaceutical
药物类别单克隆抗体, 抗体
分子靶点ERBB2
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, BioRay Pharmaceutical

作用机制

分子靶点

trastuzumab 作用于 1 个分子靶点：

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
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 cancer✓ Approved

相关研究文献

PubMedNature communications2026-10-27

Multiproperty optimization of therapeutic antibodies through sequence editing via large language model and reinforcement learning.

Qiu Minyao M, Wang Zhiwei Z, Liu Xuan X, Wang Hongzhun H et al.

Discovering antibodies with multiple beneficial properties is essential for therapeutic drug development, but experimentally identified antibodies require further optimization. Joint optimization remains challenging because sequence space is vast, annotations are sparse and property tradeoffs are common. Herein, we propose AbOptimizer, a reinforcement learning framework for multiproperty antibody optimization through parallel multisite sequence editing. AbOptimizer identifies promising editing sites and edit actions, including 'reservation', 'substitution' and optional 'insertion' or 'deletion', before recommending mutations from protein language models, while surrogate evaluation and Pareto rewards shape policy training. We evaluate AbOptimizer on three therapeutic antibodies across multiproperty, data-limited and indel-inclusive optimization. In silico, AbOptimizer improves optimized properties and outperforms baseline methods. In vitro, selected variants show affinity-specificity co-optimization for emibetuzumab, improved affinity and specificity with largely maintained thermal stability for siltuximab, and indel-inclusive affinity optimization for trastuzumab. These results validate AbOptimizer as a practical framework for therapeutic antibody optimization.

PMID 42934313
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PubMedCurrent issues in molecular biology2026-10-27

Plant Molecular Farming for Cancer Immunotherapy: Production, Glycoengineering, and Structural Insights into Therapeutic Monoclonal Antibodies.

Tamayo-Ordoñez Maria Concepción MC, García-Castillo María José MJ, Tamayo-Ordoñez Francisco Alberto FA, Suárez-Valencia Víctor de Jesús VJ et al.

Cancer is one of the leading causes of mortality worldwide, creating an urgent need for innovative, scalable, and cost-effective therapeutic strategies. Monoclonal antibodies have transformed modern oncology by enabling highly specific targeting of tumor-associated antigens and immune checkpoint pathways. However, their production in conventional mammalian cell systems remains expensive and requires extensive infrastructure. Plant molecular bioengineering has emerged as a promising alternative platform for the production of recombinant biopharmaceuticals, offering advantages such as rapid scalability, reduced manufacturing costs, biosafety, and flexible expression systems. This review summarizes recent developments in the production of plant-based anticancer biologics, with particular emphasis on therapeutic monoclonal antibodies and immune checkpoint inhibitors. The review includes plant-derived antibodies targeting HER2, PD-1, and PD-L1, which have demonstrated structural integrity, antigen-binding capacity, and biological activity comparable to those of their mammalian-derived counterparts. In this study, we performed a comparative computational structural analysis of trastuzumab and pembrolizumab using experimentally determined antibody structures as references and computationally modeled plant-associated Fc glycoforms, with particular emphasis on Fc N-glycosylation and glycan solvent accessibility. Overall, advances in synthetic biology, precision glycoengineering, and controlled cultivation technologies highlight the potential of plant biofactories as promising platforms for the development of next-generation, affordable, and globally accessible cancer immunotherapies.

PMID 42939566
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PubMedPharmaceutics2026-10-27

Targeting a Moving Threshold: Antigen Density as a Design Constraint for Particulate Drug Delivery in HER2-Low and HER2-Ultralow Breast Cancer-A Narrative Review.

Sescu Vasile Adrian VA, Filipescu Alexandru A, Solomon Condriuc Iustina Petra IP, Burac Mihaela M et al.

Trastuzumab deruxtecan has made breast tumours with minimal HER2 expression therapeutically actionable, and the descriptors HER2-low and HER2-ultralow now carry regulatory weight. Both were defined by immunohistochemical convention and trial eligibility rather than by calibrated measurement. For a receptor-directed particulate carrier the operative question is not whether HER2 is detectable, but whether enough surface-accessible receptor is present, and suitably distributed, to sustain multivalent attachment, clustering, internalisation and payload transfer. This narrative review asks whether principles established in HER2-overexpressing models, in non-HER2 receptor systems and on synthetic interfaces can defensibly be extrapolated to the HER2-low setting, keeping those evidence classes distinct. Antigen density acts at several stages of the delivery cascade rather than at binding alone, jointly with carrier design and tumour transport. An analytical constraint compounds this: fixed-tissue methods report tissue HER2 abundance but do not selectively quantify the accessible receptor pool a carrier can engage. Within the literature identified, no engagement threshold generalisable across platforms was found; the single measured value belongs to one liposomal system studied in vitro. Lesion-level carrier deposition varied widely in both human imaging datasets identified, which illustrate transport heterogeneity but are not comparable. Targetability is platform-specific, and should be measured rather than inferred from categorical HER2 status. No validated model links receptor abundance, ligand density, avidity and internalisation to biological response, so the framework offered is operational.

PMID 42942750
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PubMedJournal of clinical medicine2026-10-27

Pretreatment Body Composition Parameters and HALP Score in Relation to Pathological Complete Response in HER2-Positive Breast Cancer Receiving Neoadjuvant Systemic Therapy.

Alyıldız Neşe N, Taşcı Filiz F, Beykoz Çetin Eda E, Aydın Esra E et al.

Background/Objectives: Pathological complete response (pCR) is an important early endpoint in HER2-positive breast cancer treated with neoadjuvant therapy. Although tumor biology is a major determinant of response, the potential contribution of host-related factors such as body composition and systemic inflammatory-nutritional status remains uncertain. This study evaluated the associations of pretreatment skeletal muscle index (SMI), myosteatosis, an imaging-defined low-SMI obesity phenotype, and hemoglobin-albumin-lymphocyte-platelet (HALP) score with pCR. Methods: This retrospective single-center study included 114 patients with HER2-positive disease documented on pretreatment biopsy who received neoadjuvant systemic therapy followed by definitive surgery. CT-based body-composition measurements at the L3 level were available in 88 patients. SMI, skeletal muscle radiodensity, myosteatosis, an imaging-defined low-SMI obesity phenotype, and pretreatment HALP score were assessed. Factors associated with pCR were evaluated using Firth penalized logistic regression. Two multivariable models incorporated body-composition variables, HALP, hormone receptor status, simplified clinical T and N categories, HER2-treatment group, age, and Ki-67. Final multivariable analyses included 80 complete cases. Results: pCR was achieved in 59 of 114 patients (51.8%). Hormone receptor-negative tumors had a higher pCR rate than hormone receptor-positive tumors (74.4% vs. 40.0%; p < 0.001). Pretreatment SMI, myosteatosis, the imaging-defined low-SMI obesity phenotype, and HALP were not significantly associated with pCR in univariable analyses. In multivariable analyses, SMI and myosteatosis were not independently associated with pCR, whereas hormone receptor positivity remained associated with lower pCR odds. The treatment-group coefficient indicated lower adjusted pCR odds with trastuzumab alone than with dual HER2 blockade; however, this estimate was based on sparse complete-case subgroup data and should not be interpreted as a comparative treatment-effect estimate. Muscle attenuation and myosteatosis classification differed significantly by CT acquisition type, whereas SMI did not. Conclusions: Pretreatment SMI, myosteatosis, the imaging-defined low-SMI obesity phenotype, and HALP were not significantly associated with pCR in this cohort. Hormone receptor status remained strongly associated with response. Treatment-related estimates and attenuation-based body-composition measures should be interpreted cautiously because of sparse subgroup data, treatment-era confounding, and imaging heterogeneity. Larger prospective studies with standardized imaging are warranted.

PMID 42941441
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PubMedAntibodies (Basel, Switzerland)2026-10-26

Complement in HER2-Positive Breast Cancer: A Conditionally Protective Mechanism Under Attack.

Petkova Dobromira D, Kuleva Ivaila I, Stoyanova Zhasmin Z, Ilcheva Boryana B et al.

The therapeutic efficacy of anti-HER2 monoclonal antibodies in breast cancer has traditionally been attributed to direct inhibition of signaling and antibody-dependent cellular cytotoxicity (ADCC). Recent evidence, however, has established complement activation through the classical pathway as a possible adjunct mechanism underlying the synergistic activity of the trastuzumab and pertuzumab combination. This synergy is mediated by complement-dependent cytotoxicity (CDC) and complement-dependent cellular phagocytosis (CDCP), and is lost upon C1q deletion in preclinical models. Tumor cells evade complement-mediated killing through overexpression of membrane-bound complement regulatory proteins (mCRPs), particularly CD55 and CD59, which correlate with shorter disease-free survival in patients treated with trastuzumab. C1q itself plays a dual, context-dependent role: it acts as a complement-independent tumor suppressor in HER2-positive breast cancer while promoting tumor progression in most other malignancies. Emerging therapeutic strategies, including biparatopic antibodies such as zanidatamab, complement-redirecting immunoconjugates, and mCRP-targeting approaches, aim to overcome complement resistance and enhance antitumor immunity. On this basis, we propose that HER2-positive breast cancer represents a conditionally complement-protective tumor, in which the balance between antibody-directed complement activation and mCRP-mediated evasion determines treatment outcome. This review evaluates the current evidence linking complement to anti-HER2 therapy and highlights future directions for successful treatment.

PMID 42930033
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PubMedJournal of bioscience and bioengineering2026-10-26

Infusion-based solutions contribute to the stability of recombinant antibody and virus: Insights for formulation development.

Okita Yamato Y, Osawa Kentaro K, Shimbara Koki K, Onitsuka Masayoshi M

Protein-based biologics exhibit protein aggregation and loss of efficacy due to physical stress during manufacture, storage, and administration. Therefore, controlling the stresses applied in these processes is critical for maintaining product quality and therapeutic efficacy. Infusion solutions are an alternative source of nutrition for patients who are unable to receive adequate enteral nutrition. They contain excipients that help protect the protein structure. We hypothesized that infusion solutions could be used to maintain the quality and therapeutic efficacy of biologics formulations or as prototype systems for formulation optimization. In this study, we evaluated the effects of infusion-based solutions on recombinant trastuzumab and herpes simplex virus type 1 (HSV-1), two cancer therapy biologics. Among the tested solutions, a parenteral nutrition-based solution exhibited the strongest protective effects on the recombinant trastuzumab under stirring, indicated by enhanced protein solubility and fewer aggregated particles compared with those in the control (Dulbecco's phosphate-buffered saline, D-PBS). For antibodies in the parenteral nutrition-based solution, hydrophobic surface patch areas were smaller, whereas zeta potentials, indicating molecular repulsion, were more positive than those in D-PBS. Therefore, antibody hydrophobic interactions decreased and colloidal stability increased in the nutrition-based solution. Similarly, under combined agitation and freeze-thaw stress, and long-term refrigerated storage, the solution maintained high HSV-1 infectivity. Collectively, our findings demonstrated that infusion-based solutions can effectively stabilize a recombinant antibody and virus under clinically relevant stresses. This approach provides a strategy for improving the robustness of biologics formulations.

PMID 42934055
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