Delving into the Latest Updates on Pertuzumab biosimilar (Hisun Pharma) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Anti-HER2 monoclonal antibody( Zhejiang Hisun Pharmaceutical), Pertuzumab Biosimilar (Zhejiang Hisun Pharmaceutical Co., Ltd.), 帕妥珠单抗生物类似药（浙江海正药业股份有限公司）

+ [3]

Target

HER2

Action

antagonists

Mechanism

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

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

HER2 Positive Breast Cancer

Inactive Indication-

Originator Organization

Zhejiang Hisun Pharmaceutical Co., Ltd.

Active Organization

Hisun Bio Pharmaceutical Co., Ltd.

Zhejiang Hisun Pharmaceutical Co., Ltd.

Beijing Mabworks Biotech Co., Ltd.

Inactive Organization

BioRay Biopharmaceutical Co., Ltd.

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 18505H

The sequence is quoted from: *****

Sequence Code 18492L

The sequence is quoted from: *****

[Translation] A single-center, randomized, double-blind, parallel-controlled phase I clinical trial to compare the pharmacokinetics and safety of a single intravenous infusion of recombinant anti-human epidermal growth factor receptor humanized monoclonal antibody injection HS627 (two strengths) and PERJETA® in healthy male subjects

主要目的：评价两种规格HS627（210mg/7mL、420mg/14mL）与PERJETA®在健康男性受试者中单次静脉输注的药代动力学相似性。次要目的：评价两种规格HS627与PERJETA®在健康男性受试者中单次静脉输注的药代动力学特征；评价两种规格HS627与PERJETA®在健康男性受试者中单次静脉输注的安全性；评价两种规格HS627与PERJETA®在健康男性受试者中单次静脉输注的免疫原性。

[Translation]

Primary objective: To evaluate the pharmacokinetic similarity of two strengths of HS627 (210 mg/7 mL, 420 mg/14 mL) and PERJETA® in healthy male subjects after a single intravenous infusion. Secondary objectives: To evaluate the pharmacokinetic characteristics of two strengths of HS627 and PERJETA® in healthy male subjects after a single intravenous infusion; To evaluate the safety of two strengths of HS627 and PERJETA® in healthy male subjects after a single intravenous infusion; To evaluate the immunogenicity of two strengths of HS627 and PERJETA® in healthy male subjects after a single intravenous infusion.

Start Date11 Apr 2022

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+2]

NCT05323981

/ CompletedPhase 1

A Single Center, Randomized, Double-blind, Parallel Controlled Phase I Trial Comparing the Pharmacokinetics and Safety of Two Specifications of HS627 Injection, a Recombinant Humanized Anti-Human Epidermal Growth Factor Receptor Monoclonal Antibody Injection, With PERJETA After a Single 420mg Intravenous Dose in Healthy Male Subjects

To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects

Start Date11 Apr 2022

Sponsor / Collaborator

BioRay Biopharmaceutical Co., Ltd.

CTR20202048

/ CompletedPhase 1

健康男性受试者单次静脉输注重组抗人表皮生长因子受体人源化单克隆抗体注射液（HS627）和 PERJETA®的单中心、随机、双盲、平行对照药代动力学和安全性的相似性 I 期临床试验

[Translation] A single-center, randomized, double-blind, parallel-controlled phase I clinical trial to compare the pharmacokinetics and safety of a single intravenous infusion of recombinant anti-human epidermal growth factor receptor humanized monoclonal antibody injection (HS627) and PERJETA® in healthy male subjects

主要目的：评价HS627与PERJETA®在健康男性受试者中单次静脉输注的药代动力学相似性。次要目的：评价HS627与PERJETA®在健康男性受试者中单次静脉输注的药代动力学特征；评价HS627与PERJETA®在健康男性受试者中单次静脉输注的安全性；评价HS627与PERJETA®在健康男性受试者中单次静脉输注的免疫原性。

[Translation]

Primary objective: To evaluate the pharmacokinetic similarity of HS627 and PERJETA® after a single intravenous infusion in healthy male subjects. Secondary objectives: To evaluate the pharmacokinetic characteristics of HS627 and PERJETA® after a single intravenous infusion in healthy male subjects; To evaluate the safety of HS627 and PERJETA® after a single intravenous infusion in healthy male subjects; To evaluate the immunogenicity of HS627 and PERJETA® after a single intravenous infusion in healthy male subjects.

Start Date13 Oct 2020

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with Pertuzumab biosimilar (Hisun Pharma)

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100 Translational Medicine associated with Pertuzumab biosimilar (Hisun Pharma)

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100 Patents (Medical) associated with Pertuzumab biosimilar (Hisun Pharma)

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1

Literatures (Medical) associated with Pertuzumab biosimilar (Hisun Pharma)

01 Sep 1981·Journal of Pharmacy and PharmacologyQ3 · MEDICINE

The neuromuscular and autonomic blocking effects of azasteroids containing choline or acetylcholine fragments

Q3 · MEDICINE

Article

Author: SINGH, H ; HARVEY, A L ; PAUL, D ; MARSHALL, I G ; BHARDWAJ, T R

AbstractNine analogues of the azasteroid muscle relaxant chandonium have been tested for neuromuscular blocking activity, ganglion blocking activity, inhibitory effects on cardiac muscarinic receptors, and for effects on noradrenergic transmission. Experiments were performed in anaesthetized cats and in isolated preparations. The two bisquaternary compounds HS-626 and HS-627, choline and acetylcholine-like analogues of chandonium respectively, were approximately equipotent with chandonium as neuromuscular blocking agents in the cat, but HS-672 possessed slightly more vagal blocking action. No evidence was obtained for ganglion block. The monoquaternary analogues, HS-408 and HS-465 and two 4-aza-androstanes, (HS-522 and HS-523) were more than 100 times less active than the bisquaternary compounds as neuromuscular blocking agents, and produced vagal blockade and ganglion blockade at sub-neuromuscular blocking doses. pA2 determinations in the chick biventer cervicis muscle, the guinea-pig atria and guinea-pig ileum showed that the bisquaternary compounds chandonium, HS-626 and HS-627 were much more potent in blocking cardiac than intestinal muscarinic receptors and that HS-626 possessed the widest margin between concentrations blocking the nicotinic receptors at the neuromuscular junction and the cardiac muscarinic receptors. Evidence for the three bisquaternary compounds blocking neuronal noradrenaline reuptake was obtained only at very high concentrations. HS-626 possessed a slightly more desirable spectrum of activities than chandonium, but the degree of improvement over the parent compound is insufficient to merit extensive clinical testing.

100 Deals associated with Pertuzumab biosimilar (Hisun Pharma)

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External Link

KEGG	Wiki	ATC	Drug Bank
D05446	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	NDA/BLA	China	Hisun Bio Pharmaceutical Co., Ltd.	28 Oct 2024
Breast Cancer	Discovery	China	BioRay Biopharmaceutical Co., Ltd.	30 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2013	Not Applicable	Breast Cancer	-	murine anti-HER2 monoclonal antibodies (10H8)	jgdzadxsmv(ukgkiyjlkf) = titnfzcywg zccfnmalwr (gtkfziqwfw )	-	20 May 2013
				trastuzumab	jgdzadxsmv(ukgkiyjlkf) = ypcdwecakv zccfnmalwr (gtkfziqwfw )

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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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 (Hisun Pharma)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation