bio-pharmaceutical company with expertise of regenerative … · 2020. 11. 30. ·...

Copyright ⓒ 2020 BR PHARM CO., Ltd. all rights reserved.

Bio-pharmaceutical company with expertise of regenerative medicine

BR PHARM is bio-pharmaceutical company

specialized studying and developing APIs, medicine,

medical devices and also cosmeceuticals.

Business Scop

Medicine Medical Device Cosmeceuticals Food

PDRN API

PDRN Inj.

PDRN/PN Healer

PN Intra-articular Inj.

HA Dermal Filler

Lipolysis Inj.

PDRN Cosmetics

Anti-pigment

Anti-trouble

<Research and development in

Progress>

Location

Research Institute

Marketing&Sales

Head office & Factory

API production facility

Seoul

Won-Ju

Go-Heung

Overview

History

Obtained KGMP for pharmaceutical injection

Listed PDRN raw material medicine on DMF(Drug Master File) & bGMP

Obtained China FDA total 31 kind of products (since 2017.03)

Started contruction of API production facility in Goheung-gun

Obtained CE for cross-linked hayluronic acid filler

Obtained Cosmetic GMP, ISO22716

Signed a MOU with Jollanam-do Goheung-gun

Completed construction of 1st factory in Wonju

Signed a MOU with Jollanam-do Oceans Fisheries Science Institute

Obtained GMP certification from MFDS

Obtained ISO13485(No. 820083) for HA and PDRN

Obtained license of pharmaceutical manufacturing

Changed company name to BR Pharm Co., Ltd.

Obtained license of medical device manufacturing

Established BR Beautiful Revolution Co., Ltd.

• 2020.03

• 2019.01

• 2018.04

• 2017.11

• 2017.11

• 2017.09

• 2016.12

• 2016.10

• 2016.07

• 2016.02

• 2015.12

• 2015.07

• 2015.06

• 2014.08

• 2005.07

PDRN

Identity

PDRN(PolyDeoxyRiboNucleotide)is DNA derived from a controlled purification

and sterilization process of the sperm of Oncorhynchus mykiss (Salmon Trout).

PDRN is a well-known stimulator of cell growth that that accelerates cell

proliferation and can help with the regeneration of skin and tissue. Due to

95% similarity between human DNA and PDRN,

It is proven to be safe and effective

95% identical

BR PHARM’s PDRN

Raw material (sea trout) seawater culture,

No-antibiotic, Eco-friendly Growth Environment

Self-developed high purity PDRN purification

technology(Patent pending)

Active Pharmaceutical Ingredients(API)

approved by KFDA(MFDS)

Raw materials with proven safety (Trout / salmon)

Raw materials grown in a safe environment from chemicals and harmful substances

PDRNPurification Technology

PDRN molecule size control technology according to the application

High Purity PDRN extraction technology(Remove unnecessary protein)

Certified production facility

Systematic quality control and safety test process

Manufacture production at certified production facilities

Safe raw materials

BR PHARM’s PDRN is..

BR PHARM’s PDRN

01 02 03Eco-Friendly Trout Farming

Trout Growth MeasurementDisease screening

PDRN PurificationQuality Test 04

Produce PDRN raw materials and finished products in GMP area

Thorough quality control and traceability from raw material state, and produce PDRN pharmaceutical ingredients with proprietay PDRN separation and purification technonology in bGMP certified facility

Sea trout farming

(History Tracking, ISO9001&HACCP

Certified )

BR PHARM's original

PDRN separation

extraction technology

and safety test

KFDA Certified PDRN

GMP certified production facility

BR PHARM’s PDRN

Study of PDRN’s wound healing effect

Annals of Dermatology Vol. 31, No. 4, 2019

Polydeoxyribonucleotide (PDRN) stimulates wound healing at diabetic mouse model.Digital camera images (D3200; Nikon, Tokyo, Japan). It was confirmed that the area of the wounds was reduced visuallywith time after skin damage. PBS: phosphate-buffered saline

Effects of polydeoxyribonucleotide (on cytotoxicity and proliferation in human dermal fibroblast neonatal (HDF-n) cells. (A) The cytotoxicity of PDRN was measured using CCK-8 reaction solution in on HDF-n cells. The percentage of viable cells was expressed as a proportion of control cell viability, which was set to 100%. (B) The cell proliferation of HDF-n cells at 48 and 72 hours. The number of HDF-n cells treated with PDRN.

SCIE (Science Citation Index Expanded)

BR PHARM’s PDRN

(2) Assessment of a PDRN injection in healing wounds (Chung-Ang Univ., Korea, 2014.09)

•

(1) Research about wound healing at State University of North Carolina. PDRN Research Paper

published on International Academic Journal leveled at SCI (2016.07)

( North Carolina A&T State University,

Effects of polydeoxyribonucleotide s (PDRN) on wound healing: Electric cell substrate impedance sensing (ECIS) )

(PDRN의 상처 치유 효과)

Study

Certification

Certifications

✓ Drug Master File for PDRN API ✓ KGMP (PDRN Injection)✓ bGMP for PDRN API

Certifications

✓ ISO 13485 ✓ GMP

Certificate of Free Sales

✓ CFS (issued by MFDS, Korea FDA)

Certifications

CE2292 (Medical Device Directive 93/42/EEC)Cross-linked Hyaluronic acid filler(Class III)

CE2265, Medical Device Class III, No. 2020-MDD/QS-068 PN Intra-artcular injection

Patent

• 2019.12 Manufacturing method of high purity DNA fragments mixtures (10-2053221)

• 2019.08 Manufacturing method of high purity DNA fragments mixtures (10-2019-0065676)

• 2014.10 A cosmetic composition having an anti-inflammatory and skin regenerative effect (10-1452313)

• 2013.10 Seborrheic alopecia agent and kit for photodynamic therapy comprising the tryptophan containing

(10-1318659)

• 2013.09 Acne and sebum secretion inhibitor, and the kit for photodynamic therapy comprising the tryptophan containing

(10-1308507)

Patents about skin regeration and skin trouble care

Global Network

Global Network

Shanghai Branch Office

동남아시아

Russia,

Ukraine,

Azerbaijan,

Georgia

Southeast Asia

(Singapore, Malaysia, Indonesia, Vietnam, Thailand)

Middle East

(Iraq, Iran, UAE, Kuwait)

Head Office & Factory

(Korea)

Participating Overseas exhibition

• Europe

▪ AMWC Monaco

▪ IMCAS World Congress

• SouthEast Asia

▪ Cosmobeaute Indonesia

▪ Cosmobeaute Malaysia

▪ Vietbeauty

• Middle Ease

▪ Arab Health (UAE)

▪ Dubai Derma (UAE)

• Russia

▪ InterCharm Moscow

• China

▪ CIBE(China International Beauty Expo) (Guangzhou)

▪ CBE(China Beauty Expo) (Shanghai)

▪ CMEF(China Medical Equipment Fair)

▪ Hong Kong Cosmoprof Asia

• Korea

▪ KIMES

Thank you