Delving into the Latest Updates on Pertuzumab biosimilar (Chia-tai Tianqing) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Pertuzumab Biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.), 帕妥珠单抗生物类似药（正大天晴药业集团股份有限公司）

Target

HER2

Action

antagonists

Mechanism

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

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

HER2 Positive Breast CancerLocally advanced breast cancer

Inactive Indication

Metastatic breast cancer

Originator Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Nanjing Shunxin Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (17 Dec 2024),

HER2 Positive Breast Cancer

Regulation-

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Structure/Sequence

Sequence Code 18505H

The sequence is quoted from: *****

Sequence Code 18492L

The sequence is quoted from: *****

This is a multicenter, randomized, double-blind, parallel-controlled Phase III study to evaluate the efficacy and safety of TQB2440 injection/Perjeta® combined with trastuzumab and docetaxel in patients with early or locally advanced ER/ PR-negative HER2-positive breast cancer. The trial is scheduled to enroll 412 participants. The sample size was estimated based on 20 treatment cycles and 6 recurrence visits.

Start Date20 Oct 2020

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20201685

/ CompletedPhase 3

评价TQB2440注射液/帕捷特联合曲妥珠单抗加多西他赛治疗早期或局部晚期ER/PR阴性的HER2阳性乳腺癌患者的有效性和安全性的多中心、随机双盲、平行对照III期临床研究

[Translation] A multicenter, randomized, double-blind, parallel-controlled phase III clinical study to evaluate the efficacy and safety of TQB2440 injection/Perjeta combined with trastuzumab plus docetaxel in the treatment of early or locally advanced ER/PR-negative HER2-positive breast cancer patients

主要目的：比较TQB2440注射液/帕捷特联合曲妥珠单抗加多西他赛在早期或局部晚期ER/PR阴性的HER2阳性乳腺癌受试者的有效性。次要目的：比较TQB2440注射液/帕捷特联合曲妥珠单抗加多西他赛在早期或局部晚期ER/PR阴性的HER2阳性乳腺癌受试者的安全性和免疫性。

[Translation]

Primary objective: To compare the efficacy of TQB2440 injection/Perjeta combined with trastuzumab plus docetaxel in subjects with early or locally advanced ER/PR-negative HER2-positive breast cancer. Secondary objective: To compare the safety and immunogenicity of TQB2440 injection/Perjeta combined with trastuzumab plus docetaxel in subjects with early or locally advanced ER/PR-negative HER2-positive breast cancer.

Start Date14 Oct 2020

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

CTR20190593

/ CompletedPhase 1

单中心、随机、双盲、单剂量、平行比较帕妥珠单抗注射液与Perjeta在健康男性志愿者中PK和安全性相似性的I期临床研究

[Translation] A single-center, randomized, double-blind, single-dose, parallel phase I clinical study comparing the PK and safety similarities of Pertuzumab Injection and Perjeta in healthy male volunteers

评价帕妥珠单抗注射液与Perjeta在健康男性志愿者单次皮下注射给药的药代动力学（PK）相似性、安全性、耐受性和免疫原性。

[Translation]

To evaluate the pharmacokinetic (PK) similarity, safety, tolerability and immunogenicity of pertuzumab injection and Perjeta after a single subcutaneous injection in healthy male volunteers.

Start Date27 Feb 2019

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

100 Clinical Results associated with Pertuzumab biosimilar (Chia-tai Tianqing)

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100 Translational Medicine associated with Pertuzumab biosimilar (Chia-tai Tianqing)

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100 Patents (Medical) associated with Pertuzumab biosimilar (Chia-tai Tianqing)

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1

Literatures (Medical) associated with Pertuzumab biosimilar (Chia-tai Tianqing)

Frontiers in Oncology

A historical controlled study of domestic trastuzumab and pertuzumab in combination with docetaxel for the neoadjuvant treatment of early HER2-positive breast cancer

Article

Author: Wang, Lei ; Yang, Jixin ; Li, Nanlin ; Xu, Xiaolong ; Li, Yike ; Yang, Liu ; Wen, Xinxin ; Wang, Yijia ; Wu, Jiang ; Ma, Wen ; Yu, Jing ; Xu, Dongdong ; Wei, Hongliang ; Yang, Yuqing

BackgroundHER2-positive molecular breast cancer subtypes are characterized by high aggressiveness and malignancy, and their metastasis and mortality rates are among the highest of all types of breast cancer. The use of anti-HER2-targeted agents in neoadjuvant therapy has significantly improved the prognosis of patients with HER2-positive breast cancer. In this study, we investigated the efficacy and safety of a neoadjuvant Chinese THP regimen (docetaxel, trastuzumab biosimilar TQB211 plus the pertuzumab biosimilar TQB2440 or pertuzumab) for ER/PR-negative and HER2-positive breast cancer in China.MethodAll enrolled patients received the THP regimen (T: docetaxel 75 mg/m2 per cycle; H: trastuzumab biosimilar TQB211 8 mg/kg in the first cycle and 6 mg/kg maintenance dose in cycles 2 to 4; P: pertuzumab biosimilar TQB2440 or pertuzumab 840 mg in the first cycle, maintenance dose 420 mg in cycles 2 to 4) every 3 weeks for 4 cycles. The biosimilar TQB2440 pertuzumab and pertuzumab were randomly assigned to patients. Docetaxel, TQB211, and TQB2440 were all developed by Chiatai Tianqing. The primary endpoint was the complete pathological response (pCR) in the breast, and the secondary endpoint was cardiac safety. ResultsOf the 28 eligible patients, 19 (67.9%) achieved tpCR. The tpCR rate was higher than in the NeoSphere trial (pCR63.2%) and the PEONY study (tpCR52.5%). The adverse events that occurred most frequently were leukopenia and neutropenia, with incidence rates of 82.1% and 75.0%, respectively. Of these, grade 3 leukopenia and neutropenia occupied 46.4% and 35.7%. Other grade 3 or higher adverse events were bone marrow suppression (7.1%), lymphopenia (3.6%), and anemia (3.6%). There were no events of heart failure in patients and no patient died during the neoadjuvant phase. ConclusionDomestic dual-target HP has a more satisfactory efficacy and safety in the neoadjuvant phase of treatment.Clinical trial registrationhttps://clinicaltrials.gov/study/NCT05985187, NCT05985187.

100 Deals associated with Pertuzumab biosimilar (Chia-tai Tianqing)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC13	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	17 Dec 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally advanced breast cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	20 Oct 2020
Metastatic breast cancer	Preclinical	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	27 Feb 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05985187 (SABCS2023) Manual	Phase 3	HER2 Positive Breast Cancer	412	TQB2440	(sptqojvzfj) = xobmkzozsy yvvjfdzdaj (bxbkjijqsw ) View more	Similar	05 Dec 2023
				Perjeta	(sptqojvzfj) = qefjfyuqgy yvvjfdzdaj (bxbkjijqsw ) View more

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Approval

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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.

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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

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Pertuzumab biosimilar (Chia-tai Tianqing)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation