[Translation] A randomized, double-blind, single-dose, parallel-designed pharmacokinetic and safety study of trastuzumab for injection (150 mg) in healthy male subjects

主要目的：评价正大天晴药业集团南京顺欣制药有限公司新旧工艺生产的注射用曲妥珠单抗在健康男性受试者单次静脉给药的药代动力学（PK）相似性。次要目的：评价正大天晴药业集团南京顺欣制药有限公司新旧工艺生产的曲注射用曲妥珠单抗在健康男性受试者单次静脉给药的安全性、耐受性和免疫原性。

[Translation]

Primary objective: To evaluate the pharmacokinetic (PK) similarity of trastuzumab for injection produced by the new and old processes of Nanjing Shunxin Pharmaceutical Co., Ltd. of Chia Tai Tianqing Pharmaceutical Group in healthy male subjects after a single intravenous administration. Secondary objective: To evaluate the safety, tolerability and immunogenicity of trastuzumab for injection produced by the new and old processes of Nanjing Shunxin Pharmaceutical Co., Ltd. of Chia Tai Tianqing Pharmaceutical Group in healthy male subjects after a single intravenous administration.

Start Date08 Oct 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20201685 / Active, not recruitingPhase 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]

CTR20181909 / CompletedPhase 3

比较TQ-B211联合多西他赛与赫赛汀联合多西他赛治疗乳腺癌患者的III期临床研究

[Translation] Phase III clinical study comparing TQ-B211 combined with docetaxel and Herceptin combined with docetaxel in the treatment of breast cancer patients

主要目的：比较 TQ-B211 与赫赛汀联合多西他赛一线治疗HER2阳性转移性乳腺癌患者的有效性。次要目的：比较 TQ-B211 与赫赛汀联合多西他赛一线治疗HER2阳性转移性乳腺癌患者的安全性、免疫原性。

[Translation]

Primary objective: To compare the efficacy of TQ-B211 and Herceptin combined with docetaxel as first-line treatment for patients with HER2-positive metastatic breast cancer. Secondary objective: To compare the safety and immunogenicity of TQ-B211 and Herceptin combined with docetaxel as first-line treatment for patients with HER2-positive metastatic breast cancer.

Start Date26 Nov 2018

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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

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

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

External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	CN	Nanjing Shunxin Pharmaceutical Co., Ltd.	25 Jul 2023
HER2-positive gastric cancer	CN	Nanjing Shunxin Pharmaceutical Co., Ltd.	25 Jul 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Early Stage Breast Carcinoma	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Oct 2023
Metastatic breast cancer	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Oct 2023
Metastatic Gastric Carcinoma	Phase 1	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Oct 2023

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