[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)

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	-

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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TQ-B211 (SABCS2023)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-positive	386	TQ-B211	uvxncqutmx(sgfakhvoxv) = expkjcxpda rlplkvedbq (nzyiidzxad, 78.65 - 89.06) View more	Positive	05 Dec 2023
				Herceptin	uvxncqutmx(sgfakhvoxv) = uftamzgavi rlplkvedbq (nzyiidzxad, 72.56 - 84.15) View more
TQ-B211 (SABCS2021)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-positive	386	TQ-B211	pagtawxxky(liflihtanb) = mpgzgbyrrr psgsrzalim (invickfwhr, 78.65 - 89.06) View more	Positive	31 Oct 2021
				Herceptin	pagtawxxky(liflihtanb) = xicihrdlik psgsrzalim (invickfwhr, 72.56 - 84.15) View more

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