Delving into the Latest Updates on Trastuzumab biosimilar (Anhui Anke) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Recombinant anti-HER2 antibody(Anhui Anke Biotech), 重组人HER2单抗 (安徽安科生物), 安赛汀

Target

HER2

Action

antagonists

Mechanism

HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases

Active Indication

HER2 Positive Breast CancerHER2-positive gastric cancer

Inactive Indication

Germline BRCA-mutated, HER2-negative metastatic breast cancerMetastatic human epidermal growth factor 2 positive carcinoma of breast

Originator Organization

Anhui Anke Biotechnology (Group) Co., Ltd.

Active Organization

Anhui Anke Biotechnology (Group) Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (27 Oct 2023),

HER2 Positive Breast CancerHER2-positive gastric cancer

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 18481

Sequence Code 44772

评价 HuA21 注射液联合曲妥珠单抗联合化疗治疗 HER2 阳性局部晚期/转移性胃癌患者的安全性和耐受性；初步评价 HuA21 注射液联合曲妥珠单抗联合化疗治疗 HER2 阳性局部晚期/转移性胃癌患者的有效性，为Ⅲ期临床试验研究设计和给药剂量方案的确定提供依据

[Translation]

To evaluate the safety and tolerability of HuA21 injection combined with trastuzumab and chemotherapy in the treatment of patients with HER2-positive locally advanced/metastatic gastric cancer; to preliminarily evaluate the effectiveness of HuA21 injection combined with trastuzumab and chemotherapy in the treatment of patients with HER2-positive locally advanced/metastatic gastric cancer, and to provide a basis for the design of Phase III clinical trials and the determination of dosing regimens

Start Date25 Mar 2024

Sponsor / Collaborator

Hefei Hankemaibo Biotechnology Co., Ltd.

CTR20170516

/ CompletedPhase 3

比较HER2单克隆抗体与赫赛汀治疗HER2阳性MBC患者的疗效、安全性及体内代谢体征的多中心、随机、双盲Ⅲ期临床试验

[Translation] A multicenter, randomized, double-blind phase III clinical trial comparing the efficacy, safety, and metabolic signs of HER2 monoclonal antibodies and Herceptin in the treatment of HER2-positive MBC patients

主要目的：比较注射用重组人HER2单克隆抗体与赫赛汀在治疗HER2过度表达转移性乳腺癌患者疗效的类似性。次要目的：比较注射用重组人HER2单克隆抗体与赫赛汀在治疗HER2过度表达转移性乳腺癌患者的安全性及免疫原性。比较注射用重组人HER2单克隆抗体与赫赛汀在HER2过度表达转移性乳腺癌患者体内的代谢特征。

[Translation]

Primary objective: To compare the efficacy of recombinant human HER2 monoclonal antibody for injection and Herceptin in the treatment of patients with HER2-overexpressing metastatic breast cancer. Secondary objective: To compare the safety and immunogenicity of recombinant human HER2 monoclonal antibody for injection and Herceptin in the treatment of patients with HER2-overexpressing metastatic breast cancer. To compare the metabolic characteristics of recombinant human HER2 monoclonal antibody for injection and Herceptin in patients with HER2-overexpressing metastatic breast cancer.

Start Date22 Sep 2017

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

CTR20160642

/ CompletedPhase 1

评价注射用重组人HER2单克隆抗体在中国健康成年志愿者中单次给药的药代动力学比较试验的临床研究

[Translation] A clinical study to evaluate the pharmacokinetic comparison of a single-dose recombinant human HER2 monoclonal antibody for injection in healthy Chinese adult volunteers

通过比较药动学试验，评价单次给药后注射用重组人HER2单克隆抗体与赫赛汀的主要药代动力学参数Cmax、AUC(0- t)等其他药代动力学参数的类似性。

[Translation]

Through comparative pharmacokinetic studies, the similarity of the main pharmacokinetic parameters Cmax, AUC (0-t) and other pharmacokinetic parameters of recombinant human HER2 monoclonal antibody for injection and Herceptin after a single dose was evaluated.

Start Date02 Aug 2016

Sponsor / Collaborator

Anhui Anke Biotechnology (Group) Co., Ltd.

100 Clinical Results associated with Trastuzumab biosimilar (Anhui Anke)

Login to view more data

100 Translational Medicine associated with Trastuzumab biosimilar (Anhui Anke)

Login to view more data

100 Patents (Medical) associated with Trastuzumab biosimilar (Anhui Anke)

Login to view more data

1

Literatures (Medical) associated with Trastuzumab biosimilar (Anhui Anke)

01 Dec 2023·The Breast

Exploring the clinical outcomes and safety profile of inetetamab treatment in metastatic breast cancer patients: A multicenter assessment of a Chinese-origin recombinant Anti-HER2 monoclonal antibody

Article

Author: Cao, Min ; Feng, Ronghua ; Xiao, Huawu ; Ouyang, Quchang ; Hu, Zhe-Yu ; Liu, Binliang ; Li, Jing ; Gao, Jianxiang ; Wu, Tao ; Zeng, Mengsi ; Xie, Ning ; Tian, Can ; Shui, Zhengrong ; Liu, Liping ; Yang, Xiaohong ; Tang, Yu ; Lu, Jun ; Wu, Hui ; Hu, Xuming

BACKGROUNDInetetamab is a novel recombinant humanized anti-HER2 monoclonal antibody. This study aimed to evaluate the efficacy and safety of inetetamab and predictive factors for response in HER2-positive metastatic breast cancer (MBC) patients.METHODSA cohort of HER2-positive MBC patients who received inetetamab-based therapy between June 2020 and August 2021 was evaluated. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR) and disease control rate (DCR). Adverse events (AEs) were graded according to the National Cancer Institute Common Toxicity Criteria.RESULTSA total of 141 patients were included in the final analysis. The median PFS of the entire cohort was 7.1 months. The median number of treatment lines administered was three. The ORR was 36.9 %, and the DCR was 80.9 %. The most frequently employed treatment strategy was inetetamab + chemotherapy (49/141, 34.8 %), followed by inetetamab + HER2-tyrosine kinase inhibitors (HER2-TKIs) + chemotherapy, inetetamab + pertuzumab + chemotherapy, inetetamab + endocrine treatment and inetetamab + HER2-TKIs. Cox multivariate analysis revealed that PFS was associated with liver metastasis (hazard ratio [HR] 2.112, 95 % confidence interval [CI] 1.334-3.343, p = 0.001), previous HER2-TKI treatment (HR 2.019, 95 % CI 1.133-3.597, p = 0.017) and estrogen receptor positivity (HR 0.587, 95 % CI 0.370-0.934, p = 0.024). The toxicity was tolerable, with neutropenia being the most common treatment-related grade 3/4 AE (14.9 %).CONCLUSIONInetetamab demonstrates effectiveness with a manageable safety profile, offering a promising therapeutic option for HER2-positive breast cancer patients who have shown resistance to prior anti-HER2 treatments.

100 Deals associated with Trastuzumab biosimilar (Anhui Anke)

Login to view more data

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	China	Anhui Anke Biotechnology (Group) Co., Ltd.	27 Oct 2023
HER2-positive gastric cancer	China	Anhui Anke Biotechnology (Group) Co., Ltd.	27 Oct 2023

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Germline BRCA-mutated, HER2-negative metastatic breast cancer	Phase 2	China	Anhui Anke Biotechnology (Group) Co., Ltd.	22 Sep 2017
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 2	China	Anhui Anke Biotechnology (Group) Co., Ltd.	22 Sep 2017

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.


No Data

Trastuzumab biosimilar (Anhui Anke)

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation