Company profile for BrightGene Bio-Medical Technology Co.,Ltd

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About

BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FDFs with primary strategic focus on the regulated market. We have an exciting and very promising innovative pipeline including immuno-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug co...
BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FDFs with primary strategic focus on the regulated market. We have an exciting and very promising innovative pipeline including immuno-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug conjugates for solid tumor, novel non-antibody dependent tumor targeting conjugates for brain cancer and solid tumor brain-metastasis.

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CONTACT DETAILS

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Country
Country
China
Address
Address
Suzhou Industrial Park, Jiangsu Province
Telephone
Telephone
youtube
YouTube
Twitter
Twitter

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NEWS #PharmaBuzz

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https://www.fiercebiotech.com/biotech/brightgenes-oral-dual-agonist-sees-8-weight-loss-8-weeks-slice-early-data

FIERCE BIOTECH
25 Mar 2026

https://www.prnewswire.com/news-releases/brightgene-presents-positive-phase-2-data-for-dual-glp-1rgipr-agonist-for-weight-management-and-type-2-diabetes-and-preclinical-data-for-novel-amylin-analog-at-american-diabetes-associations-85th-scientific-sessions-302488874.html

PR NEWSWIRE
23 Jun 2025

https://endpts.com/a-chinese-company-is-already-mass-producing-gileads-experimental-coronavirus-drug/

Jason Mast ENDPTS
13 Feb 2020

http://www.pmlive.com/pharma_news/chinas_brightgene_successfully_copies_gileads_coronavirus_hopeful_remdesivir_1325639

Lucy Parsons PMLIVE
13 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212126

FDA
25 Sep 2019

USDMF

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CEP/COS

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JDMF

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Argatroban

JDMF

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 302MF10033

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2020-03-02

Latest Date of Registration : 2021-08-20

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Argatroban

JDMF

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 230MF10028

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2018-02-15

Latest Date of Registration : 2021-03-05

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Argatroban

JDMF

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 305MF10140

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2023-12-22

Latest Date of Registration : 2023-12-22

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 304MF10018

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2022-01-26

Latest Date of Registration : 2022-01-26

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 228MF10118

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2016-06-24

Latest Date of Registration : 2016-06-24

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 304MF10030

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2022-02-10

Latest Date of Registration : 2022-02-10

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 230MF10169

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2018-12-19

Latest Date of Registration : 2021-11-17

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 303MF10069

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2021-04-19

Latest Date of Registration : 2021-04-19

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BrightGene Bio-Medical Technology Co.,Ltd

Registration Number : 305MF10018

Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...

Initial Date of Registration : 2023-02-02

Latest Date of Registration : 2023-02-02

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FDF Dossiers

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Brand Name : ENTECAVIR

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Brand Name : ENTECAVIR

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BrightGene Bio-Medical Technology Co.,Ltd

Dosage Form : TABLET;ORAL

Brand Name : ENTECAVIR

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2019-09-25

Application Number : 212126

Regulatory Info : RX

Registration Country : USA

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Brand Name : ENTECAVIR

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Brand Name : ENTECAVIR

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BrightGene Bio-Medical Technology Co.,Ltd

Dosage Form : TABLET;ORAL

Brand Name : ENTECAVIR

Dosage Strength : 1MG

Packaging :

Approval Date : 2019-09-25

Application Number : 212126

Regulatory Info : RX

Registration Country : USA

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Brand Name : FONDAPARINUX SODIUM

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Brand Name : FONDAPARINUX SODIUM

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BrightGene Bio-Medical Technology Co.,Ltd

Dosage Form : SOLUTION;SUBCUTANEOUS

Brand Name : FONDAPARINUX SODIUM

Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5...

Packaging :

Approval Date : 2024-12-18

Application Number : 218312

Regulatory Info : DISCN

Registration Country : USA

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FDA Orange Book

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Brand Name : ENTECAVIR

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Brand Name : ENTECAVIR

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BrightGene Bio-Medical Technology Co.,Ltd

Dosage Form : TABLET; ORAL

Proprietary Name : ENTECAVIR

Dosage Strength : 0.5MG

Approval Date : 2019-09-25

Application Number : 212126

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Brand Name : ENTECAVIR

AMWC Asia-TDAC
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Brand Name : ENTECAVIR

AMWC Asia-TDAC
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BrightGene Bio-Medical Technology Co.,Ltd

Dosage Form : TABLET; ORAL

Proprietary Name : ENTECAVIR

Dosage Strength : 1MG

Approval Date : 2019-09-25

Application Number : 212126

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

Brand Name : FONDAPARINUX SODIUM

AMWC Asia-TDAC
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Brand Name : FONDAPARINUX SODIUM

AMWC Asia-TDAC
Not Confirmed
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BrightGene Bio-Medical Technology Co.,Ltd

Dosage Form : SOLUTION; SUBCUTANEOUS

Proprietary Name : FONDAPARINUX SODIUM

Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML...

Approval Date : 2024-12-18

Application Number : 218312

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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ABOUT THIS PAGE

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BrightGene Bio-Medical Technology Co.,Ltd is a supplier offers 73 products (APIs, Excipients or Intermediates).

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