Delving into the Latest Updates on Palifermin biosimilar(Chengdu Zhitian Biological Engineering Co Ltd) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Growth factors

Synonyms

Palifermin Biosimilar (Chengdu Zhitian Bioengineering Co., Ltd.), 帕利夫明生物类似药（Chengdu Zhitian Bioengineering Co., Ltd.）

Target

FGFR2

Mechanism

FGFR2 stimulants(Fibroblast growth factor receptor 2 stimulants)

Therapeutic Areas

Digestive System DisordersMouth and Tooth DiseasesNeoplasms+ [1]

Active Indication

MucositisHematologic Neoplasms

Inactive Indication

Stomatitis

Originator Organization

Chengdu Zhitian Bioengineering Co., Ltd.

Active Organization

Chengdu Zhitian Bioengineering Co., Ltd.Chengdu Bofa Biotechnology Co Ltd

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 31652

The sequence is quoted from: *****

The main purpose is to investigate the tolerance of lyophilized recombinant human keratinocyte growth factor and explore the maximum tolerated dose in patients with blood malignancies who are receiving autologous hematopoietic stem cell transplantation, followed by preliminary exploration of efficacy and evaluation of pharmacokinetic characteristics.

Start Date26 May 2015

Sponsor / Collaborator

Chengdu Bofa Biotechnology Co Ltd

[+1]

CTR20132639 / CompletedPhase 1

冻干重组人角质细胞生长因子在健康受试者I期临床耐受性、药代动力学及初步药效学试验

[Translation] Phase I clinical tolerability, pharmacokinetics and preliminary pharmacodynamics study of lyophilized recombinant human keratinocyte growth factor in healthy subjects

考察健康受试者接受单次和多次注射不同剂量冻干重组人角质细胞生长因子的耐受性、药代动力学及初步药效学。

[Translation]

To investigate the tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple injections of different doses of freeze-dried recombinant human keratinocyte growth factor in healthy subjects.

Start Date08 Jan 2013

Sponsor / Collaborator

Chengdu Bofa Biotechnology Co Ltd

[+1]

100 Clinical Results associated with Palifermin biosimilar(Chengdu Zhitian Biological Engineering Co Ltd)

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100 Translational Medicine associated with Palifermin biosimilar(Chengdu Zhitian Biological Engineering Co Ltd)

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100 Patents (Medical) associated with Palifermin biosimilar(Chengdu Zhitian Biological Engineering Co Ltd)

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100 Deals associated with Palifermin biosimilar(Chengdu Zhitian Biological Engineering Co Ltd)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V03AF08	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 2	CN	Chengdu Bofa Biotechnology Co Ltd	26 May 2015
Hematologic Neoplasms	Phase 2	CN	Chengdu Zhitian Bioengineering Co., Ltd.	26 May 2015
Mucositis	Phase 2	CN	Chengdu Zhitian Bioengineering Co., Ltd.	-
Stomatitis	Phase 1	CN	Chengdu Bofa Biotechnology Co Ltd	08 Jan 2013
Stomatitis	Discovery	CN	Chengdu Zhitian Bioengineering Co., Ltd.	08 Jan 2013