[Translation] Phase III clinical study comparing the efficacy and safety of HL02/WBP257 and Herceptin combined with docetaxel in the treatment of HER2-positive metastatic breast cancer

主要目的是评价HL02/WBP257和赫赛汀®在HER2阳性转移性乳腺癌患者中的疗效相似性，次要目的是评价HL02/WBP257和赫赛汀®在HER2阳性转移性乳腺癌患者中的安全性、药代动力学特征及免疫原性。

[Translation]

The primary objective is to evaluate the similarity of efficacy between HL02/WBP257 and Herceptin® in patients with HER2-positive metastatic breast cancer. The secondary objective is to evaluate the safety, pharmacokinetic characteristics and immunogenicity of HL02/WBP257 and Herceptin® in patients with HER2-positive metastatic breast cancer.

Start Date10 Sep 2019

Sponsor / Collaborator

Hualan Genetic Engineering Co., Ltd.

CTR20170988 / CompletedPhase 1

比较HL02与赫赛汀在健康男性志愿者中药代动力学和安全性、耐受性和免疫原性的药代动力学比对研究

[Translation] Comparative pharmacokinetic study comparing the pharmacokinetics, safety, tolerability and immunogenicity of HL02 and Herceptin in healthy male volunteers

试验目的是在中国健康男性受试者中评估HL02（注射用重组抗人表皮生长因子受体2）和赫赛汀的药代动力学（PK）参数，进行药代动力学（PK）比对研究；在中国健康男性受试者中比较HL02和赫赛汀的安全性、耐受性和免疫原性。

[Translation]

The purpose of the trial is to evaluate the pharmacokinetic (PK) parameters of HL02 (recombinant anti-human epidermal growth factor receptor 2 for injection) and Herceptin in healthy Chinese male subjects and conduct a pharmacokinetic (PK) comparison study; to compare the safety, tolerability and immunogenicity of HL02 and Herceptin in healthy Chinese male subjects.

Start Date21 Sep 2017

Sponsor / Collaborator

Hualan Genetic Engineering Co., Ltd.

100 Clinical Results associated with Trastuzumab biosimilar(Hualan Genetic Engineering)

100 Translational Medicine associated with Trastuzumab biosimilar(Hualan Genetic Engineering)

100 Patents (Medical) associated with Trastuzumab biosimilar(Hualan Genetic Engineering)

Literatures (Medical) associated with Trastuzumab biosimilar(Hualan Genetic Engineering)

01 Feb 2022·Expert Opinion on Biological TherapyQ3 · MEDICINE

Safety and pharmacokinetics of a new biosimilar trastuzumab (HL02): a Phase I bioequivalence study in healthy Chinese men

Q3 · MEDICINE

Article

Author: Wei, Haijing ; Ding, Yanhua ; Zhang, Hong ; Li, Xiaojiao ; Li, Cuiyun ; Liu, Li ; Chen, Hong ; Liu, Ting ; Wu, Min ; Liu, jingrui

OBJECTIVESThe study aimed to explore the bioequivalence of a proposed biosimilar HL02 vs. its reference products (US-trastuzumab) among healthy Chinese men.METHODSIn this study, nine healthy male subjects received single ascending doses of trastuzumab biosimilar (HL02, 2-8 mg/kg), and then a randomized, double-blind, two-arm, parallel study was conducted to investigate the PK similarity of HL02 (6 mg/kg) with that of US-trastuzumab as a reference drug.RESULTSPK properties exhibited by HL02 (N = 55) were similar to those of US-trastuzumab (N = 52). The comparison of biosimilarity with US-trastuzumab showed that the 90% confidence intervals (CIs) of the ratios for C_max, AUC_0-t, and AUC_0-∞ were within 80-125%. Nineteen subjects were positive for ADA and negative for NAb in both HL02 and US-trastuzumab groups. In total, 81.67% of subjects in HL02 and 78.95% in US-trastuzumab groups showed treatment-related mild or moderate adverse events, mild elevation of transaminase level being the most common adverse events (AE) recorded.CONCLUSIONSThe PK characteristics and immunogenicity exhibited by HL02 were similar to that of the reference product, US-trastuzumab. The safety profiles were similar in both the treatment groups with mild-moderate adverse effects.

100 Deals associated with Trastuzumab biosimilar(Hualan Genetic Engineering)

External Link

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	Phase 3	CN	Hualan Genetic Engineering Co., Ltd.	10 Sep 2019
Metastatic breast cancer	Phase 3	CN	Hualan Genetic Engineering Co., Ltd.	21 Sep 2017
Metastatic Gastric Carcinoma	Phase 3	CN	Hualan Genetic Engineering Co., Ltd.	21 Sep 2017

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