clinical trial

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Transcript clinical trial

Professional Company for
Pregnant Women, Babies and Children
C.A PHARM
Address : #205.2FI.,Daeryung Techno Tower 6-cha,493-6
Gasan-dong, Geumcheon-gu, Seoul 153-774 Korea
Website : http://www.capharm.co.kr Tel : 82-2-532-3478
1. Products Introduction
1) ATOPLAGENTRA
- ATOPY (p. 1-1)
- The sales point of product (p. 1-2)
- An example of clinical trials (p. 1-5)
2) PLAGENTRA
- Stretch-mark (p. 1-9)
- The sales point of product (p. 1-10)
- An example of clinical trials (p. 1-12)
3) Main ingredient (p. 1-14)
1)ATOPLAGENTRA
 ATOPY ?
-Atopic dermatitis(AD) is a pruritic disease of
unknown origin
-There has been a noticeable 30% increase in the
incidence of atopic dermatitis
Genetic factors
Environmental factors
-There are 3 major steps of atopic dermatitis
(Infant>Puberty>Adulthood)
-The 1st principles are Cleansing and moisturizing
Internal factors
Damage
of
-Resilience of skin barrier is crucial
skin barrier
Antihistamines
Steroid
Antibiotic
Pruritus
Dry skin
Infection/Eczema
Sensitive skin
Humectant
1-1
1) ATOPLAGENTRA-Patented creative material for atopic skin care
 Launching date
Jan 1. 2006
 Effectiveness of areas
Atopic, Dryness, Itching, Sensitive Skin
 Overalls Products
Soap
90g
Cleansing/Moisturizing
[Non medical products]
Wash
310ml / 200ml
For cleansing & washing
100ml
Cream
Lotion
50ml
For concentrated moisturizing
30g
For pharmacy
150ml
For moisturizing
& relieving dermatitis
100ml
Suncity Cream
70g
Protecting skin from UV ray
& pollution
Baby tissue
70pieces
Cleansing & moisturizing skin
 Sales points
약국용
 A new concept of double skin barrier function, the first in Korea – Ceramide, EGF, FGF Application of
high Moisturizing Ingredient of PGA (PolyGlutamic Acid)
 Only one medical soap, a ‘ATOPLAGENTRA’ approved by Korea Food & Drug Administration
- Simultaneous caring of atopic, dry skin, itching with cleansing and moisturizing effects
 Geneva/SIIF(Seoul International Invention Fair) : Awarded as golden and special prize from the 36th
GIIE (Geneva International Invention Exposition), the WIPO (the World Intellectual Property Organization)
grand prize from SIIF – Patented creative material of atopic skin care products.
 Selected as ‘2009 VIP(Very Important Product) ASIA’
 6 subjects of recognition / The Ministry of Health and Welfare in Japan.
1-2
1) ATOPLAGENTRA-Patented creative material for atopic skin care
• Main effectiveness
Non medical
products
* Arachis oilGetting permission from KFDA, For remedy assistance moisturizing of atopic skin
* 2 in 1 system product for simultaneous caring of cleansing and moisturizing
Double skin barrier
* The Primary function of skin barrier – Protective film of Ceramide (Existing Products)
* The Secondary function of skin barrier - To strengthen a secondary function of double barrier
by making a new cells and promoting a growth of keratin cells by the action of EGF and FGF
High moisturizing
Antioxidant
* High Moisturizing Ingredient of Polyglutamic Acid (PGA) is applied to atopic skin care
domestically for the first time.
- It is extracted from Bacillus natto of soybean
(Mucilagenous of Cheonggukjang - a fermented soybean paste used in Korean cuisine )
- It is contained about 5,000 molecules of water for each 1 PGA molecule
- It is more have moisturization 50 times than hyaluronicacid,
100 times than collagen
* Co enzymeQ10 - It can help slow the skin’s aging by suppress the propagation of
active oxygen
1-3
1) ATOPLAGENTRA
 ATOPLAGENTRA Soap (Non-medicine products)
1. The main ingredient, Arachis oil(non medicine products) is permitted ingredient to use atopic skin
from KFDA
- Psoriasis skin(Atopic skin dermatitis for Infant and adult, psoriasis , ichthyosis , senile pruritus )
Remedy assistance for moisturizing  Getting permission from the Korean authorities
- Proven ingredients officially from the world’s most famous pharmacopoeia and official documentation
 U.S, UK, European pharmacopoeia and Merk Index etc.
2. 2 in 1 system product for simultaneous caring of cleansing and moisturizing
- The existing moisturizer have been only applied for general dry skin but in case of ATOPLAGENTRA can apply for
both atopic skin and general dry skin in virtue of soap type(non medicine product) and simultaneous caring of
cleansing and moisturizing
3. A sales point
- Using ‘Long chain fatty acid’ enable to minimize skin irritation
- It enable keeping a light film of oil on the skin to prevent the loss of the water from the skin
- There is rarely no dryness of skin after use these products by keeping moisture and fraction from the skin
– Emolient effect
- People of every generation who suffer from skin disease such as atopic dermatitis, dryness, itchness can more
safely use it
1-4
1) ATOPLAGENTRA - Clinical trials
Improving
effectiveness
Improving
effectiven of
dry skin
Over 75%
Improving effectiveness of
itchiness
Over 50%
Extending duration of
보습력의 지속시간
moisturization
 Clinical trials on patients : An atopic dermatitis 60 patients
(Men 35/ Women 25)
 The period of Clinical trials : From Jun 1st to 31st Jul 2006
 CLINICAL TRIAL – Seoul Allergy Clinic (Korea)
For 2-6hour 90%
Comparing with
the existing moisturizer
Over 90% of
effectiveness
Comprehensive estimation
Over 70% of customer
satisfaction
1. Most of Subjects who have been suffering from atopic dermatitis
for a long time. But the result was recognized to be of superior
quality if they only use our ATOPLAGENTRA products
1) When you look at those main check list and comprehensive estimation,
it will show you that we can guarantee excellent quality than
our competitors and the obvious products that contain major ingredients
EGF, FGF for clinical trials.
2) Considering their atopic dermatitis was very severe on their skin of
the body, It will be more effective a person who have any atopic
dermatitis is less severe or mild
 The age range - Over the age of 15 : 47%,
Over the age of 5 : 43%, Under the age of 5 : 10%
 Symptoms of Clinical trials on patients : A patient suffering from
severe atopic dermatitis for years or a few decades
 A main ingredients of Product : EGF, FGF, PGA, Co enzymeQ10,
Ceramide etc.
2. According to those reports on the results of clinical trials,
it can be summarized in two sales points of ATOPLAGENTRA products
1) Those cell growth facts such as EGF, FGF are basically made to
help skin recover its original skin condition 'the function of double
skin barrier' without recourse to the existing ceramide of single skin barrier
2) A best & new moisturizing ingredient, Polyglutamic acid is far superior to
the existing moisturizing ingredient, hyaluronic acid about high moisturizing
effect and lasting hour
1-5
1) ATOPLAGENTRA - An example of Clinical trials
Atopy
Eczema
Psoriasis
1-6
1) ATOPLAGENTRA - An example of Clinical trials
1-7
1) ATOPLAGENTRA - An example of Clinical trials
1-8
2) PLAGENTRA
 Definition of Stretch-mark
In medical terminology, Stretch-marks are known as `striae distensae`. the skin becomes wrinkled and cracked as a
result of destroying the collagen fibers of the corium or losing elastine fibers caused by physiological or physical facts
 Cause of Stretch-mark
1. Physiological facts (Internal) : Increasing adrenocortical hormone of the body
2. Physical facts (External) : Sudden weight gain or loss, Strength in adulthood etc
 Type of Stretch-mark
1. Stretch-mark of pregnant women
2. Stretch-mark of growing adolescents
3. Stretch-mark due to a diet or a drastic weight change of heavy exercise
4. Endocrinology diseases, Chronic wasting disease, Taking steroids for a long
5. Heavy exercise to strengthen the muscles or Stretching etc.
 Mainly occur Stretch-marks on the area of skin
1. Pregnant women :
Belly > Breast > Thigh > Waist > Hip
2. Teenager : Calf > Thigh > Hip
* The annual number of pregnant women : About more than 400,000 in Korea, 16 million in China, 25 million in Other Asia countries
1-9
2) PLAGENTRA
 Launching date
Aug. 2001
 Effectiveness of areas
Anti Stretch-mark for pregnant women, growing adolescents, a diet
or a drastic weight change due to heavy exercise, etc.
 Overalls Products
Soap
Cream
80g
Natural Soap – Deep cleansing
50g
For dry & sensitive skin
(extensive management)
130g
30g
Lotion
150ml
Oil
110ml
For pharmacy
For all skin type
- general purpose, prevention
For dry skin & massage
Hands clean gel
70ml
99% sterilization & moisturizing effect
약국용
 Sales points
 No.1 Brand in Korea for stretch marks
- The cumulative sales volume has exceeded 2 million, Occupying a market share of 40% in Korea
 Not only can certainly help prevents stretch marks, but improves stretch marks have been created as well
 The first in Korea, prescribed EGF & FGF and contained CoQ10 for stretch marks product
 Awarded the grand prize ‘Premium Brand 2009’
 Awarded the golden and WIPO prize from the SIIF(Seoul International Invention Fair)
1-10
2) PLAGENTRA
 Main sales points
1. PLAGENTRA : The professional skin care products vary in depending on your skin type
- PLAGENTRA Cream (Blue)
: For dry & sensitive skin / Intensive care
- Bio PLAGENTRA Cream (Green)
: For oily & normal skin / Intensive care
- PLAGENTRA Lotion
: For all skin type/general purpose, prevention
- PLAGENTRA Oil
: Especially dry skin (Autumn/Winter), For belly massage of pregnancy women
2. Not only can certainly help prevents stretch marks, but improves stretch marks have been created as well
- EGF(epidermal growth factor) and FGF(Fibroblast Growth Factor) – Skin regeneration / Promoting healthy collagen
- CoenzymeQ10 – Antioxidant, Preventing aging skin
3. PLAGENTRA : It grows more effective the more you use like those Cream, Lotion and Oil also we can continue to use
- There is nothing else for Stretch-mark Product only except PLAGENTRA : If you use it only lightly moisten and apply it
like ointment
- In case of intensive care, you’d better use and apply ‘Cream’ more effectively, but in case of wide skin area and
less intensive care, you’d better use and apply ‘Lotion’ and ‘Oil’
1-11
2) PLAGENTRA - An example of Clinical trials
Belly
Hips
Calf
1-12
2) PLAGENTRA - An example of Clinical trials
1-13
3) Main ingredient - EGF&FGF
EGF & FGF - Cell growth factor
 EGF (Epidermal Growth Factor) & FGF (Fibroblast Growth Factor)
 It is growth factor is very significant new substance of genetic engineering for the cracked skin, whitening, and atopy which
acts as core functioning to maintain beautiful, live and bouncing skin by facilitation of Skin Regeneration, and Collagen and
Elastin generation.
 It is extracted by mass production of culturing bacteria E.coli or Yeast
The epithelial cell – growth effect, It shows
the effect which is excellent promotes the growth
of 50% degree by the EGF 100pg/ml(0.1ppm)
The fiber cell- growth effect, It shows the effect
which is excellent promotes the growth of 50%
degree by the FGF 50pg/ml (0.05ppm)
1-14
3) Main ingredient
Hydrolyzed Soy Protein – Vegetable amino acid
 Soybean’s placenta extracts: It means ‘Phyto placenta’ or ‘Vegetable placenta’
- It is the Hydrolyzed Soy Protein, and contained abundant natural amino acid
 Cell-growth, cellular renewal accelerator, increased synthesis of protein, especially quantity
have Alanine, Proline
 Increased collagen, elastin regenerateness.
 Increased cell turn-over 26%
1-15
3) Main ingredient
Glabridine – second-generation
Whitening ingredient
 A utility glycyrrhizin
 Anti-melanin effects/Anti-oxidation effects/ antibiosis effects
 Inhibitive action of melanin coloring matter’s creation
- It is powerful Tyrosinase enzyme of obstruction action
- twice more than Albutine, the quantity more than Ascorbic
acid about 642
 There is no skin stimulus, chemical stabilization
CoenzymeQ10 – anti-oxidant agent
Other names are Ubidecarenone or Ubiquinone.
 Vitalization of skin cell – Most strong anti-oxidant element.
 Delay the skin aging by suppressing active oxygen.
 Help the anti-oxidation function of vitamin E
1-16
3) Main ingredient
PGA (Polyglutamic acid) - Moisturizing component
 The first in Korea, application of atopy skin care and high-moisture component
 It is extracted from echo bio germs of soybean sticky material of fermented soybean (chung gook jang)
 PGA in 1 element is contained 5000 hydrone ( Hyaluronic acid’s 50 times, Collagen’s 100 times )
Change of Water content in the corneal layer
Change of Transdermal water content loss
1-17
2. Company Introduction
1)
2)
3)
4)
5)
6)
7)
8)
9)
Management Philosophy (p. 2-1)
Company History (p. 2-2)
Business goals and plan for future (p. 2-3)
Status of Intellectual Property (p. 2-4)
Actual results of winning prizes (p. 2-6)
Exhibition Materials (p. 2-8)
Clinical trials data (p. 2-12)
The press release (p. 2-14)
Broadcasting data (p. 2-15)
1) Management Philosophy
 We will realize to provide safe and effective products which are verified clinically
and scientifically.
 We will concentrate to develop nature friendly products based on natural ingredients.
 We will enhance the client’s value to return our company’s profits to society based on
reliability of our customer.
Respect
for life
Naturalism
Return to
social
benefit
2-1
2) Company History
2009 Dec VIP ASIA AWARDS 2009’ the Best Product ‘s top 100 of the Year [ATOPLAGENTRA]
– AVING Global News Network (AVING)
6 subjects of recognition / the Ministry of Health and Welfare in Japan.
Nov The 5th Korean Best Manager of the Year [Eco administration]
– The Korean Academic Association of Business Administration/ The Asia Economy Daily
Oct Premium Brand Award chosen by Women Customer [PLAGENTRA] – The life of a housewife / The Daily sports
Sep Korea’s new growth engines of excellence company [Global Health care] - The moneytoday
Jun Entered into the agreement of ‘Industry-University Cooperation’ with Kyung-Pook University
Apr Chosen as ‘KOTRA Seal of Excellence’ brand
Feb Certified the approval of GH (good health) mark – KHIDI
Jan USA FDA / EU / Vietnam registration Accredited as a ‘INNO-BIZ Company’
2008 Apr Awarded as golden and special from the 36th Geneva International Invention Exposition
Jun Completed China hygiene authorization of 5 products and Conclusion of a contract to export (China)
Jul Certified Skin Science Laboratory – KOITA [Korea Industrial Technology Association]
Sep Accredited as a Venture Company
Dec Awarded the golden and WIPO prize from the ‘Seoul International Invention Fair’
2007 Dec Participated Korea Invention and patent competition [ bronze award ]
Sep Selected as Korea Quality Innovation Company in Han-Kyung
2006 Jan Selected as 2006 Women satisfaction superiority products by ca Newspaper
2005 Dec Selected CA Pharm as “2005 Top brand award for customer satisfaction” by Sports Seoul
Jul
Changed to C.A Pharm Corporation
2004 Apr Awarded as excellence company in quality management / CEO from Vision Korea Project
2003 Dec Awarded as golden brand award from Korea Service Management Promotion Association
Mar Selected as “prospection company and brand of 2003” by Sports Seoul
Initiated clinical trial with Kyung-Hee Medical Center/Donga Medical Center
2002 Jun Introduced Placentra PLACENTRA soap
2001 Aug Established C.A Pharm (18 Aug) / Introduced PLACENTRA cream
2-2
3) Business goals and plan for future
 2010 : Baby Diaper Rash Cream
 2011 : Launching BT Products
(Academic-industrial collaboration - Gyung-Pook University)
 2012 : Pushing ahead with plan to construct factory
Listing on KOSDAQ
Setting a $8.3 million export target for 2012
 2013 : Setting a year’s sales goal at KR(\)40 billion [US$3.3 million]
 2014 : Pushing ahead with plan to construct laboratory
Listing on the stock market
 2016 : Setting a year’s sales goal at KR(\)100 billion [US$83 million]
(Registering a Hidden Champion Company)
2-3
4) Subjects of recognition
- The Domestic recognition
 INNOBIZ Company / Venture Company / Establishing an adjunct laboratory
 Applying for 6 patents/ Registering 10 Trade marks/ 5 clinical trials data/ 2 ISO Certifications
INONO-BIZ (Jan 2009)
Certificate of Venture
Company (Sep 2008)
Establishing an adjust
laboratory(Jul 2008)
Registering Trade marks
(C.A Pharm, PLAGENTRA, ATOPLAGENTRA, PLADERM, SUNCITY etc.)
Clinical trials
(Seoul allergic Clinic)
Applying for patents
(Stretch-mark. ATOPY, Internet exhibition etc.)
Safety test
(Chung-buk University)
ISO
2-4
4) Status of Intellectual Property
- Overseas
 Certificate of Hygiene for 5 Products in China / Vietnam / 6 subjects of recognition(Japan)
FDA / EU Products Registration / 2 Clinical trials data
6 subjects of recognition / the Ministry of
Health and Welfare in Japan. (Dec 2009)
Registration of products in Vietnam
(Apr 2009)
Certificate of Hygiene for 5 Products in China
(Jun 2009)
U.S FDA Registration (Feb 2009)
EU Product Registration
(Apr 2009)
Registering Trade mark in China (Jun 2008)
2-5
5) Actual Results of winning prizes
 Awarded the golden and special prize
from the ‘2008 Geneva International
Invention Exposition’ – Apr 2008
 Awarded the golden, special and WIPO prize from the
SIFF(Seoul International Invention Fair) – Dec 2008
WIPO Prize
WIPO Medal
Gold Prize
- Overseas
Gold Prize
Golden Prize
Special Prize
Special Prize
2-6
5) Actual Results of winning prizes
VIP ASIA 2009’
the Best Product of the Year
[ATOPLAGENTRA] – Dec 2009
The 5th Korean Best Manager
of the Year [Eco administration]
– Nov 2009
Korea’s new growth engines of excellence company
[Global Health care] – Sep 2009
- The Domestic recognition
Premium Brand Award chosen by
Women Customer
[PLAGENTRA] – Oct 2009
‘KOTRA Seal of Excellence’ brand – Apr 2009
History of the award from 2003 to 2007
2-7
6) Exhibition Materials - Overseas
2009
Cosmoprof Asia 2009 in Hongkong
(11~13 Nov)
The 106th China Import and Export
Fair[Canton Fair] (15~19 Oct)
The 9th International Baby and Children
Products EXPO 2009 in Shanghai ,china
(29~31 Jul)
The 1st China(Chongqing) Beauty Industry
Expo In Chongqing, China(4~8 Nov)
Thailand Baby Mum Best buy 2009
(27~30 Aug)
Cosmoprof North America
in Las vegas, US (12~21 Jul)
Korean Products Show 2009,
Chengdu (16~19 Oct)
The 5th Parenthood Expo 2009 (21~23 Aug)
Baby & kids World 2009
in Tokyo, Japan (8~10 Jul)
2-8
6) Exhibition Materials - Overseas
2009
Shenyang Oea department fair
(7~11 May)
Cosmoprof bologna 2009 in Italy
(2~6 Apr)
2008
Guangzhou International Fair
for Mother & Baby (14~18 Oct)
2008 Geneva International Invention
Exposition (2~6 Apr)
Cosmoprof Asia 2008 in Hongkong
(11~15 Nov)
India Beauty Expo 2008 (13~7 Oct)
Consultation of Export to China
in Beijing, China (3~5 Apr)
2-9
6) Exhibition Materials - Overseas
2007
“World best Korean Products Show 2007” in Singapore
- Official visiting of ex-president Roh, mu-hyun. (19~21 Nov)
7th International Baby and Children Products
EXPO 2007 in Shanghai ,china (23~25 Jul)
2-10
6) Exhibition Materials - Domestic (Korea)
The 16th Seoul International Fair
for Mom & Baby (Coex,)
Busan Baby & Kids Fair 2009
Mom & Baby Expo Spring 2009 (KINTEX,)
Daegu Baby & Kids Fair 2009
Gwangju Baby & Kids Fair 2009
Daejeon Baby & Kids Fair 2009
2-11
7) Clinical trials data - Domestic(Korea)
 CLINICAL TRIAL –
Seoul Allergy Clinic (Korea)
 Clinical trials on patients : An atopic dermatitis 60 patients
(Men 35/ Women 25)
 The period of Clinical trials : From Jun 1st to 31st Jul 2006
 Clinical trials laboratory : Seoul Allergic Clinic
 The age range - Over the age of 15 : 47%,
Over the age of 5 : 43%, Under the age of 5 : 10%
 Symptoms of Clinical trials on patients : A patient suffering from
severe atopic dermatitis for years or a few decades
 A main ingredients of Product : EGF, FGF, PGA, Co enzymeQ10,
Ceramide etc.
 SAFETY TEST–
Chungbuk National University (Korea)
Liver
Kidney
Heart
Brain
2-12
7) Clinical trials data - Overseas
 Summary of test result report –
YanBian University(China)
2-13
8) The press release
2-14
9) Broadcasting data
On KBS 1TV – Dec 26, 2009
On Life and Health TV
On ArirangTV are broadcasted in 118contries
worldwide
On Kyeongin Broadcasting TV
On Trade association TV
2-15
Thank you!
Where you can find
C·A PHARM Products