matters for inquiry

Patent Application: 10-2013-0163415Invention title: Functional composition for prevention and alleviation of female vaginitis

matters for inquiry

Division director JOHN LEE

E-mail - [email protected]

Jung’s Laboratory of Immunology Co., Ltd. is devoted to developing lactic acid bacteria application core materials and products. The basic technology has been developed in order to combine the core materials with all products. Due to the impossibility of approaching all enterprises, partial products are mass-produced directly and circulated directly on the market. Ⅰ. Company introduction

and history

1. Company overview

3

Company Name Jung’s Laboratory of Immunology CEO Kim Sungok

Founded Date May 16, 2011Number of regular employ

ees10

Company Registration Number

110111-4602424Business Registration Num

ber119-86-42195

Head Office Location

599, Gwanak-ro, Sillim-dong, Gwanak-gu, Seoul504-323, College of Natural Sciences of Seoul National Univ.

TEL. 070-7423-2928

Business Food R&D, production of microbial preparations, writing, trade, consultation of technology, wholesale and retail, etc.

Major contents of research

Lactic acid bacteria fermented GABA, functional lactic acid bacteria powder, lactic acid bacteria salt, lactic acid bacteria cup tofu, lactic acid bacteria Starter kimchi, female vagina cleanser, child growth product, HAT(Detox) product, anti-obesity diet food, bittern-free tofu made with lactic acid bacteria culture solution, lactic acid bacteria beverage, bean milk yogurt, lactic acid bacteria kimchi sausage, tofu residue cookie, functional cosmetics using lactic acid bacteria, immunopotentiators, antifungal immunomodulator, microbial environment preparation, etc.

Related institutions and compa

nies

NOVAREX Co., Ltd., NUTRI BIOTECH Co., Ltd., JINMI Co., Ltd., KBS HUTOS, DOYEOMWON Co., Ltd., JEWON INTERNATIONAL Co., Ltd., TRICOM Co., Ltd., JK FOOD Co., Ltd., KNP Cosmetic Co., Ltd., TAEKYUNG FOOD Co., Ltd., ENSKIN, VIXXOL Co., Ltd., SANMALL Co., Ltd., YEUDANG Co., Ltd., TOBICO Co., Ltd., SMARTLAB Co., Ltd., MEDIOGEN Co., Ltd., FHONET Co., Ltd., GOOD SEED Co., Ltd., HK COMMUNICATION Co., Ltd., Han Hong Ui life health, Dr. Han Hong Ui kimchii, Kim Jeong Moon Aloe Co., Ltd., LG Electronics Co., Ltd., SAEAM FOODMENT Co., Ltd.

2. Research representative

4

1972 ~ 1976 Department of Microbiology, College of Liberal Arts and Sciences / College of Natural Sciences, Seoul National Univ. (Bachelor of Science)

1976 ~ 1978 Graduate School for Microbiology, Seoul National Univ. (Master of Science)

1978 ~ 1980 Graduate School for Microbiology, Seoul National Univ. (Doctor course completion)

1980 ~ 1985 Graduate School for Medical Science, Cornell University Medical College (Ph.D. in Immunology)

Education

1980 ~ 1985 Sloan-Kettering Institute for Cancer Research

1984 ~ 1985 Cetus Corporation (Ad hoc Consultant)

1986 ~ 2000 Department of Microbiology, College of Natural Sciences, Seoul National Univ. (assistant professor/ associate professor/ professor)

2000 ~ Present Immunology Lab, Biological Sciences, College of Natural Sciences, Seoul National Univ. (professor)

2011~ Founded Jung’s Laboratory of Immunology Co., Ltd.

Experience

1997 Korea BRM Conference Academic Award

From 1995, successive service as general affairs manager/academic chairman/auditor, present director in the Microbiological Society of Korea, service as operation committee member, etc., in several conferences like the Microbiological Society of Korea

2000 Venture company Microbia technology president (approved by personnel committee of Seoul National Univ.)

2010 Publishing “tracing novel flu secrete” (Academic information center Journal)

Activities

Ⅰ. Company introductionand history

1. Explanation of product

2. Characteristics of product

3. Development purpose

4. Patent application technology

5. Product overview

Product introduction of PANTOC

2

5

Always moist in vagina causing easy propagation of bacteriaWeak acid environment in vagina

Breaking of the balance in vagina causing vaginitis, smell, itching, etc.

PANTOC

Necessary lactic acid bacteria produc

t for keeping the vagina inside envir

onment

Optimal lactic acid bacteria activity p

roduct living in the vagina

Leucorrhea

Secretion

Smell

Eczema

Itching

Vaginitis

Solving the trouble with Secret Toctoc

2. Characteristics of product

2. Product introduction of PANTOC

6

Improvement of female vagina environment of 1~100 years old

2. Characteristics of product - continued

Easy to carryCoating on panties, diaper

Forinfant

Forladies

Common usefor bothmen andwomen

Easy to carryCoating on panties, panty liner

Foradult


7

Through the period of puberty, growth of lactic acid bacteria in vagina is activated owing to the influence of female hormone estrogen, and consequently pH in vagina keeps at 4.5~5.5 to suppress

the growth of microbes capable of hindering the cleanliness in vagina. When the external factors including overcleaning, etc., are applied to the vagina inside environment, the microbial colony growing in vagina may collapse unconsciously. In this case, it is impossible to increase the pH in

vagina or eliminate all the lactic acid bacteria living ordinarily. Moreover, through the menopause, lactic acid fermentation stops and the vagina inside environment becomes dry to show various

menopause symptoms. Mostly, hormone method is used for treatment, but the method has side effects.

In order to recover the vagina inside environment of women in menacme and postmenopausal women like the environment of the period of puberty, normal pH is kept to suppress growth of

unnecessary microbes and to gain the advantages of normally living lactic acid bacteria.

Candida albicans inducing candidiasis is the microbe (fungus）even detected on the normal person having no symptom. When the body of person becomes weak due to diseases like the flu, etc., or

the person takes antibiotics for the reason of prescription, it propagates suddenly in vagina to show the abnormal symptoms.

Mostly, candidiasis needs prescription separately.

Consequently, abnormal microbial colony in vagina is managed such that the acidity in vagina can be kept normally to recover the normal colony in vaginal quickly and to prevent various diseases.

3. Development purpose


8

4. Patent application technology

Screening of lactic acid bacteria andCharacteristics of lactic acid fermentation

Finally screened good bacteria from primarily screened lactic acid bacteria screened from patients based on the data including:-various standard fitness property including final acidity, etc.-survival rate in Staphylococcus mixed culture-survival rate in E. coli mixed culture

Three kinds of lactic acid bacteria were identified in the laboratory of Han Hong Ui professor, InhaUnivHanersity and the institute for genomic research, Seoul National University.

Good Bacteria 1

Good Bacteria 3

Good Bacteria 4

Good Bacteria 5

Good Bacteria 2


9

10

4. Patent application technology-continued

Change of viable count in single culture of lactic acid bacteria Change of acidity and viable count in GPY and

GGPY medium of good bacteria 5

Good Bacteria 1Good Bacteria 2Good Bacteria 3


10



In mixed culture of lactic acid bacteria

Change of viable count in mixed culture of lactic acid bacteria and S. aureus

Time-dependent change of pH and acidity in mixed culture of E.coli and lactic acid bacteria



In mixed culture of lactic acid bacteria

E. coli+lactic acid bacteria, pH

E. coli+lactic acid bacteria, acidity

Change of viable count in mixed culture of lactic acid bacteria

Change of viable count in mixed culture of E.coli and lactic acid bacteria


11

Good Bacteria

1


In the mixed culture of two kinds of bacteria capable of inducing the bacterial vaginosis and the screened three kinds of lactic acid bacteria, it was confirmed that the pathogenic microbes

(having high probability of infection) were eliminated completely within 24 hours. MB01 was the lactic acid bacteria having strongest viability among the screened lactic acid bacteria. In the

mixed culture, pH increased by 0.45 - 0.49% with 24 hours, and pH dropped to 3.75-3.77. As a result, it was confirmed that the bacteria inducing the bacterial vaginosis can be suppressed

completely within 24 hours by the mixed culture of the three kinds of lactic acid bacteria in GPY broth.

Time-dependent change of pH and acidity in mixed culture of S. aureus and lactic acid bacteria

Good Bacteria

2

Good Bacteria

3

S. aureus+lactic acid bacteria, pH

S. aureus+lactic acid bacteria, acidity


12

Above information based on the clinical data from long-term clinical trials

[ Products Feature ]

Vaginitis alleviation effect Addition technology developed with patent lactic acid bacteria

1

Antibacterial and deodorization effects up to 99.9% withthe patent lactic acid bacteria

(Korea Environment Merchandise Testing Institute)Having effects on antibacterial and deodorization, leucorrhea

Various clinical trials Various effects were confirmed through the clinical trials performed in national

and international prominent universities and famous experiment institutions(Daejeong ● ●obstetrics and gynecology, Incheon ● ● ● obstetrics and gynecology)

Recovering healthy vagina inside environment

2

3

4

5. Product overview


13

Result

1. General interest in women’s hygiene and usage behavior

2. Purchase intention of lactic acid bacteria powder product

and usability evaluation

3. Considerations when buying lactic acid bacteria powder

product

4. Overall insight into lactic acid bacteria powder product

14

1. General interest in women’s hygiene and usage behavior: usually used sanitary pad

Primary reasons to choose certain type of pads are many: feel, aroma, deodorization, and quick absorption. Use frequency of sanitary pad appears high before and after period. In other words, sanitary pad products must be helpful to relieve sensitized women’s sentiment during period.

Explain

Response

20s’Group

30s’Group

40s’ Group

Usually used sanitary pad(Reason to use)

• GoodFeel –Soft touch feeling and good for

outdoor activities

• Yejimiin Oriental Herb – Good for deodorization

• White –Natural fit when wearing skinny jean

• Body fit – Good absorption and softest touch

among others

• GoodFeel Oriental Herb – Best for deodorization

• White – Good for deodorization with all different

sizes

• Yuhan-Kimberly overnight - Thickest among

others

• Whisper –Good absorption

• Whisper – Rash developed when using other

products

• Yejimiin Oriental Herb – Good touch and aroma

• White –Rejection developed when using other

products

• Prerequisite condition for sanitary pad : No odor

Use frequency of usually used sanitary pad

• Panty liner used everyday

• Used for as long as 5 days before and after

period.

• Used before/after period

• Not using every day

• For daughters, pad used after period only for

short and remove

15

1. General interest in women’s hygiene and usage behavior: understanding of hygienic stress level and demands on sanitary goods

Response

20s’Group

30s’Group

40s’Group

Hygienic stress level

• Have serious dysmenorrhea

and stronger odor during

winter season

• Not under heavy stress

usually

• Were told odor becomes

stronger after taking shower

• Have stronger odor as paying

less attention to hygiene

after marriage

Most women are sensitive to hygiene and body odor during period Only simple cleansing products (soap or general cleanser) are used to keep good hygienic condition Women cannot use appropriate hygienic products despite of high level of related stress as no properly functioning

products are available

Explain

Special product used for hygiene

• Use cleanser when taking

shower or if necessary

• Use vagina cleanser

everyday to eradicate

bacteria

• Use soap instead, but prefer

to washing out with water

• Vagina cleanser

• Vagina cleanser (stick type)

“Wish to have” hygienic product

• Do not use any vagina

cleanser as it is said no

benefit come. Wish to have

a better product

• Wish to have a dry and soft

feeling product as both panty

liner and pad become sweaty

when walking

• Wish to add deodorization

function to panty liner.

• Foam-type cleanser

• Spray type powder cleanser

• Pumping type plastic cleanser

16

2. Purchase intention of lactic acid bacteria powder product

All age groups are positive to lactic acid bacteria powder product. In particular, females in their 40s are most interestedin the product as they are sensitive to odor

As vagina cleanser kills good bacteria as well, women show positive response to spraying-type of lactic acid bacteriapowder

Lactic acid bacteria powder product is expected to remove moisture and odor coming from pad

Explain

Purchase intention oflactic acid bacteria powder product

• Willing to use as it is new and non existent before

• Interested in the product as foods with lactic acid are known good for health

• Willing to use as it provides soft feeling and good aroma while removing dampness

• Worrying that powder would not be well absorbed as powder tends to smudge on skin

• Interested in the product as it is good for deodorization and health.

• Believing that it would be helpful to keep hygiene as it can substitute for vagina cleanser when going out for long

• Would buy the product after seeing the market response as the effect is not proven yet.

20s’

30s’

VOC summary

• Expecting the product would be helpful to lower the health related anxiety during period and it is good for health and easy to carry.

• Expecting that anti-bacterial and prevention functions while using wet tissue for cleanness

• Irritating to spray powder again when changing pads

40s’

(Unit: 1-9 scale)

20s’ 30s’ 40s’ Average

17

3. Considerations when buying lactic acid bacteria powder product:additional improvement of lactic acid bacteria powder product

Most favored flavor for lactic acid bacteria powder is herb as it can go well with cosmetics scent or body odor. Most answered type of lactic acid bacteria powder is spray type (easy to apply). Customers also wish to have spray

improved to avoid smudging or leaking Some answer it would be good if it comes in as elegant package as cosmetic products

Explain

Flavor favored to add tolactic acid bacteria powder product

Additional effect or product type to add tolactic acid bacteria powder product

• Spray type : compressed vacuum spray type

• Other type : Roll-type liquid, melting type like dry ice, scattering type like pepper bottle to prevent secondary infection, and brush-shaped stick

• Color: Mild and transparent color such as pastel tone, peach, or mint

• As luxurious package as cosmetics: Easy grab

• Enhanced durability : Not to be broken

• Particles of lactic acid bacteria powder are smeared out to surface of pad or liner: Skin adherence is doubtful

• Better feeling: Not only good quality lactic acid bacteria but also dry and soft touch required. To avoid rash

• Lactic acid bacteria tissue would come in to supplement the powder product

• Finer powder and less dispersing

• Puff (sponge) of powder and portable type must be washable and quick to dry

(unit: frequency)

Herb

Fruit

Powdery

Others

No flavor

18

4. Overall insight into lactic acid bacteria powder product by age group

20s’Group

40s’Group

30s’Group

• Prefer portable type over powder compact type for better portability and usability

• Prefer mild or no flavor

• Price sensitive

• Willing to pay higher prices, become positive towards lactic acid bacteria powder product as using more

often

• Less stressed regarding hygiene compared to 20s and 40s


• Prefer flavored product. Not prefer no-flavored one .

• Intended to pay higher prices than 20s and 40s (20,000 -30,000 won range)


• Conservative to flavor of product: susceptible how its aroma would turn after it mixes with body odor or

other cosmetics

• Price sensitive and conservative. Prefer to see a doctor. Consider cheap products as unreliable

• Put same importance on both appearance and usability

In general, portable type is preferred over powder type, flavor depends on individual but natural herb is most favored.

Awareness on the effect of lactic acid bacteria is low so that promotion is highly important. Word-of-Mouth marketing seems necessary

with users’ review.

Reasonable and competitive price would range between 10,000 – 20,000 won.

It is required to improve the package design. The package must contain the powder tight and it must do not look like a hygienic product

but like cosmetic goods.

Active promotion on the effect of lactic acid bacteria seems requirement by setting up POP, promotional phrases, and event shelf by

supermarket, pharmacy, and CVS. By doing so, it would enhance the awareness of lactic acid product, leading to purchase.

Marketability would be good enough if awareness on the effect of lactic acid bacteria is raised in the market where healthy hygienic

product for female is short.

Overall Insight

19

Consumer Clinical Test Results Report

Survey overview

1. Survey Background

1) Verification of efficacy of non-oral h genitalia vaginal lactobacillus through genitalia contact

2. Goals

1) Improvement of vaginal health index after consumer test for 4weeks

2) Confirming the marketability of the product, including how to use the product, capacity and price

3. Survey method HUT(home usage test)

1) Check health status before using product, then check improvement level in weekly basis for 4weeks

2) Survey was committed without alternative product for comparison.

20

4. Survey target

5. Survey schedule

May 3, 2016 - May 31, 2016 (+1 week) A total of 4 weeks

subject of recruitment subject of recruitment object of investigation

age Average 35 years old

Employees of Medipost who recently (within a week) suffering with

symptoms of vaginitis (secretion / itching / odor), but hasn’t got any

medical treatment Number of participants

3 out of 38 gave up during the survey

Excluding 4 cases of mild vaginitis patents 5 patients

among 35 patientsN=31

Actual data analysis

21

Product overview

1. Product Type: Cosmetics2. Main ingredients and content of product3. How to use: once a day, after shower, before bedtime,

Spray 2-3 times on underwear where touch female genitalia. 4. esearch and Development Institute5. Expiry date: 2years from date of manufacture

human body cleaning product in particular pudenda

Basic Cosmetics Products in particular Powder (EX. Baby Powder)

Anti-body odor products in particular Other

Ingredients

(lactobacillus plantarum MB01, lactobacillus acidophilus), ※ lactobacillus plantarum MB01Two kinds of lactobacillus (lactobacillus plantarum MB01, lactobacillus acidophilus), rice starch ※ lactobacillus plantarum MB01: patented lactobacillus originated by Kimch

Number of injected bacteria 30 billion CFU / bottle (7 g) 100 million CFU / injection

Assured number of bacteria 1 billion CFU / bottle (7 g)

test results10.5 billion CFU / bottle (7 g), production on October 7, 2015, inspection in June 2016

Packing capacityPacking capacity 7g (300 times spraying, Lasting100 days if used3 times a day)

22

http://endic.naver.com/enkrIdiom.nhn?idiomId=413788e48829458491d5a1c433ff27e4&query=%EC%97%AC%EC%84%B1%EC%9D%98+%EC%83%9D%EC%8B%9D%EA%B8%B0

none

Slight

with symptoms but do not feel much

about it.

normal

Start feeling uncomfortable due

to symptoms

severe

Feeling uncomfortable and

hard to keep up with daily life due to

symptoms

Very severe

Category 0 1 2 3 4

Amount of secretion

Secretion odor

Secretion color

Secretion form

stimulation on pudenda

pain on pudenda

Other symptoms

SCORE assessment

1.score measurement form on vaginitis

23

2. Improvement results after use of PANTOC based on vaginitis symptom

As it is tested by patients who do not receive hospital treatment, they scoredmild vaginitis symptoms (average 1 point).

Vaginitis symptoms (Score)

(N=31) Control group

division Before use 1 week 2 week 3 week 4 week

Amount of secretion

1.87±0.67a 1.55±0.85ab 1.29±0.82bc 1.03±0.75cd 0.91±0.87d

Secretion odor 1.65±0.75a 0.19±0.87b 0.84±0.78cd 0.74±0.86d 0.55±0.81d

Secretion color 1.50±0.73a 1.26±0.82ab 0.90±0.75bc 0.81±0.75cd 0.48±0.77d

Secretion form 1.10±0.94a 0.65±0.75ab 0.57±0.68ab 0.26±0.58b 0.32±0.54b

stimulation on pudenda

1.45±0.77a 0.90±0.94b 0.94±1.00b 0.68±0.83bc 0.35±0.61c

pain on pudenda 0.37±0.61a 0.39±0.62a 0.16±0.45a 0.16±0.45a 0.16±0.37a

Other symptoms 0.50±0.68a 0.23±0.50a 0.29±0.53a 0.10±0.40a 0.13±0.43a

24

division

Mean score (0 ~ 28) of Cognitive Symptom change rate 기간별 증상 인지 변화율

사용 전After use (mean ± standard deviation) After use (%) After use (%)

1주 2주 3주 4주 1주 2주 3주 4주

Experimental group

8.35 ±2.24a*

6.16 ±2.93b

4.97 ±3.09bc

3.77 ±2.94cd

2.81 ±3.12d

-26.23 -40.48 -54.84-66.35

F-value(p-value)

17.404(0.00)

•Value in a row with different (a-d) differ significantly (p<0.05) by ANOVA with Duncan correction

3. Changes in Cognitive Score of vaginitis symptoms after 4 weeks* Value in a row with different (a-d) differ significantly (p<0.05)by ANOVA with Duncan correction

25

Product under development

26

1. Lactic acid bacteria powder for women

2. Sanitary pad

3. Panty liner

4. Vagina cleanser

5. Sanitary tissue

6. Sanitary underwear

7. Cosmetics for vagina

8. Sexual function products

9. Cleanser for sexual function product

10. Vagina cleansing wash

11. Diaper for girls

12. Diaper for female patients

matters for inquiry

Documents

Transcript of matters for inquiry