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A sustainable innovative company Sep.2016
Introduction
Core competence
Pipeline
1
3
2
BrighGene Bio-Medical Group
Introduction-Overview
 Business Total solution provider
APIs and Intermediates manufacturer
(US, EU and CFDA GMP certified)
 Specialties Innovative drugs
Niche specialty generics with high technical barrier
 Mission Serve for global customers with unique products and
solutions
Introduction-Overview
Introduction-Milestone
 2001 BrightGene Bio-Medical founded by Dr.Yuan
 2006 BrightGene developed a non-infringing process of Entecavir
 2010 BrightGene Pharmaceuticals founded---Suzhou
 2011 BrightGene fine chemicals founded---Taixing
 2012 BrightGene Fermentation R&D founded---Chongqing
First DMF filed
 2013 US FDA EIR report received
 2015 EU GMP approved
CFDA GMP approved
 2016 US FDA EIR report received
Introduction-Investment
Introduction-Overview
Suzhou
Taixing
Chongqing
Location
3 sites in China
Introduction-Organization Structure
BrightGene
Bio-Medical
BrightGene R&D
Institute
Suzhou
Innovative drug
Niche generic
Chongqing
Fermentation
BrightGene
Fine Chemical
Taixing
Intermediate
BrightGene
Pharmaceutical
Suzhou
API & FDP
R&D
Production
Introduction-BrightGene R&D Institute
Advanced
facility
Integrated
Platform
 10000+m2 lab area
 280+ scientists
 120+ HPLC
 400M NMR
 LC-MS
 Hot-Melt Extrusion
 Multi-chiral center
 Semi-synthesis
 Nano injection
 Innovative drugs
Introduction-BrightGene R&D Institute
Introduction-BrightGene R&D Institute
Overview-BrightGene Fine Chemical
US and EU GMP approved
 20m3 fermentation tank
 5m3 fermentation tank
 Nano filtrate membrane 50m2
 8m3 extraction tank
 3m3 concentration tank
 200L Crystallization tank
 2m3 & 3m3 reactor
Overview-BrightGene Fine Chemical
Overview-BrightGene Fine Chemical
Overview-BrightGene Pharmaceutical
10000+m2 Mfg. area
6 API workshops
100L & 300L reactors
3 formulation workshops
Lyophilization
Prefilled injection
Oral solid dosage
US, EU and CFDA GMP approved
Overview-BrightGene Pharmaceutical
Core competence
R&D Driving
Manufacturing
Capability
Regulatory
Ability
Core competence---R&D Driving
Difficult to synthesis, semi-synthetic APIs and
intermediates
Non-infringing process development and
optimization
Non-infringing polymorph screening
New formulations and 505B2 candidates
Core competence---Manufacturing Capability
FDP
API
Intermediates
Vertical Integration
Core competence---Regulatory Ability
IP
• 136 patent,
31 authorized
• 6 PCT,
2 authorized
RA
• 7 DMF filed in
US
• 1 ASMF filed in
EU
• 19 APIs filed in
CFDA
QS
• CFDA GMP
• US FDA
approved
• EU GMP
Core competence
R&D
Driving
Manufacturing
Capability
Regulatory
Ability
Total Solution to global customer
Stable Commercial
Supply
Pipeline-DMF
DMF filed DMF to be filed
1 Fondaparinux sodium Ready
2 Posaconazole form III Ready
3 Micafungin Ready
4 Anidulafungin Ready
5
Posaconazole
intermediate A
Ready
6
Posaconazole
intermediate B
Ready
7 Posaconazole form I Ready
8
Pemetrexed
intermediate
Ready
9 Everolimus Ready
1 Entecavir intermediate 026257
2 Posaconazole 028314
3
Fondaparinux sodium
intermediate
028552
4
Fidaxomicin
(Crystalline)
028803
5 Ascomycin 029433
6 Caspofungin Acetate ASMF
7
Micafungin
intermediate
030028
8 Pimecrolimus 030090
Pipeline-Category
Animal Healthcare
1 Doramectin
2 Selamectin
3 Milbemycin
4 Pirlimycin
5 Moxidectin
Others
1 Fondaparinux Sodium
2 Entecavir
3 Posaconazole
4 Edoxaban
Anti-Infection
1 Caspofungin
2 Micafungin
3 Anidulafungin
4 Fidaxomicin
5 Dalbavancin
6 Oritavancin
Iron Products
1 Ferric Carboxymaltose
2 Ferumoxytol
3 Ferric citrate hydrate
4 Triferic
Immunology
1 Pimecrolimus
2 Everolimus
3 Temsirolimus
ADC Toxin
1 Ansamitocin P-3
2 Maytansinol
3 DM-1
4 DM-4
5 MMAE
6 MMAF
BrightGene Bio-Medical Group
Sales Department | Abby Wu
abby.wu@bright-gene.com Sep. 2016

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Introduction of BrightGene-Abby