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Success Story of EstroG-100
Novel Proprietary Standardized Healthcare Ingredient Naturalendo Tech Co., Ltd.
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Company Profile - Facts & Figures
Established in May 24, 2001 Headquartered in Pangyo (10 minutes from Gangnam (Seoul)), Korea Initial Public Offering: Oct 31st, 2013 in KOSDAQ Business Lines: Proprietary Herbal Remedy (EstroG-100) IGF-1 Secretagogue (YGF-251) Hormone Disruptor Inhibitor Immune Enhancer Skin Care Formula, etc. 2014 Sales Revenue: $ 124 mil. in 2014 In-house Manufacturing Facility Fastest growing bio venture & largest biotech in terms of the sales of in-house developed health functional food ingredient in Korea
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Summary of Healthcare Industry & Our Product Line-up
Characteristics of Healthcare Industry Difficult to enter into a market due to long-term investment in R&D and a massive capital investment High value-added industry Service to the Public Health Insensitive to Economy Fluctuation Healthcare Industry Device & Equipment U – Healthcare Pharmaceutical Nutraceutical Cosmeceutical Others Insurance Health Machine Hospital & Clinics Novel Ingredient Our Products hGH Secretagogue EstroG-100 Derma A2 TDDS
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Function of Estrogen Growth and development of uterus and mammary gland Expression of secondary sex characteristics Control of menstrual cycles and supporting pregnancy Bone metabolism and increase of BMD Cardiovascular health and lipid metabolism Anti-dementia, trophic factor for neuron Colon cancer prevention Teeth health Prevention of macular degeneration Fat distribution to subcutaneous fat tissue Collagen production and maintaining human skin
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Menopause Classification
Premature Menopause About 8% Women (US) stop having period before age 40 Same symptoms as Menopause Peri-menopause Average women go through this phase age 45~49 Wildly fluctuating Estrogen Level Menopause Estradiol level<50 pg/mL; FSH>50 mIU/mL; no period for >1 yr* Average age for onset of menopause is 52 in US Symptoms last 2~19 years, many more than 5 years Surgical Menopause After Hysterectomy/Bilateral surgery * Definition: Dr. Joel Harglove, MD, Chairman, Vanderbilt Menopause Center, Nashville, TN
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After Menopause, Women Suffer…
Women spend almost half of their lives in pre-, peri- and post-menopause. Physiological /Psychological Changes During Menopause Hot flashes, Night sweats Vaginal dryness & thinning of vaginal wall Inelastic skin and dry eye, insomnia, nervousness, depression, paresthesia(numbness), vertigo(dizziness), fatigue, rheumatic pain(joint), pounding of heart, headaches Long Term Post-Menopausal Health Risks Cardiovascular Diseases (CVD’s) : 2 times higher risk of CVD’s after menopause Osteoporosis
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EstroG-100
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Executive Summary Solution for Women’s Quality of Life
EstroG-100 is dominating the Korean market by occupying over 90% share of total menopause market, including HRT and herbal remedies. Features Market Status Benefits Patents, Licenses, and approvals 17 registered and pending patents worldwide Health Canada NPN License NDI Notification Accepted by US FDA HFFI by MFDS (Korea FDA) Expected to obtain Novel Food Approval from EU Commission 1Q 2015 Successful sales in Korea, US, Canada and Southeast Asian countries. Ranked No.1 over more than 45 products of HRT & Black cohosh since in Korea Supplying to Korean major companies & its sales hit 340milliion USD in retail price in 2014 Clinically proven efficacy and safety Significant improvement of 10 menopausal symptoms out of 12 in total QOL improvement FBMD significantly improved No side effects compared to other alternatives including HRT, Black Cohosh and Isoflavone.
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R&D & Commercialization of Novel Healthcare Ingredients
Competency Production & Purchasing In-house Manufacturing Site Contract Farming R&D Center Diverse Pipeline & Differentiated R&D Patents Marketing & Sales Differentiated Marketing & Major Company Loyalty R&D & Commercialization of Novel Healthcare Ingredients
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EstroG-100 a. Positioning in the industry
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New History on Healthcare Ingredients
Sales of Major Herbal Medicines (million USD) Stillen: the Korean Blockbuster Herbal Medicine of Dong-A Pharm sold in US$85 mil. Joins: the Korean Major Herbal Medicine of SK Chemical in US$35 mil. (Ministry of Health & Welfare, 2012) Factive: the 1st Korean Drug approved by U.S. FDA sold in US$17 mil in 2011 but decreased to US$9 mil. in 2012 (Asia Economics, 2013) Sales of EstroG-100 in Retail Price (million USD) EstroG-100 has been supplied for Korean majors and its sales hit in Retail Price: USD mil. USD 55 mil. USD 100 mil. USD 270 mil. USD 340 mil.
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Dominance in Korean Menopause Market
Market Share in Korea Menopause Market (W100mn) Began sales from Aug. 2010 Established $340m market 2014 Established $270m market 2013 Established U$100m market Dominating over Other Ingredients 2012 No.1 Ingredient in Korea 2011 * Total sales have been converted to consumer prices since we have been supplying EstroG in the type of ingredient, semi-finished products, finished products, and our own brands. Source : Korea Pharmaceutical Manufacturers Association, Korea Export Association
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Global Estrogen Market Share
Line-up of Major Global Partners Global Sales to Increase Pioneering potential global market Replacing Global Pharma + Supplement Market 2014 Major partners in each country 2013 2012 Global Supplement companies Big Pharma * Global sales of HRT products and Naturalendo’s sales converted to consumer price.
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Penetrating Global Market
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EstroG-100 B. Competitors in the market
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Other Estrogen Alternative - (1) HRT
Women’s Health Initiative Study (WHI) National Institute of Health (NIH) sponsored 8.5-year study with 16,000 subjects to estimate the benefits and risks of HRT The Study was terminated early at 5 years with increased risks of breast cancer (26%), CVD (22%), stroke (41%), coronary heart disease (29%), blood clots (100%), Alzheimer's (100%) US FDA required “Black Box Warning” Prescribed ONLY for <4 weeks JAMA July 2002
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Side effects of hormones reported Low-dose hormones release
Other Estrogen Alternative - (1) HRT Negative Results of WHI’s Clinical Studies on HRT In U.S., HRT prescription significantly dropped since 2002 “Soaring Needs for Safe and Natural Alternative, EstroG-100” JAMA 2004; 291; 1770 Side effects of hormones reported Non-hormones release Low-dose hormones release Ref: GBI Research (2009)
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Other Estrogen Alternative - (2) Pomegranate
Pomegranate, just a fruit “Any estrogen is not included under error range in this prove. In addition, any estrogen is proven not to be detected in 7 different pomegranate fruits. Coumestrol the phytoestrogen is not detected in the supplements either not as known to public to be included in the seeds.” ザクロを使った健康志向食品 - エストロゲンは本当に含まれているの? (Supplement using pomegranate – Estrogen included?) 国民生活センター, [2000年4月6日:公表] ●結果・現状 今回調べた範囲ではエストロゲンは検出限界以下で検出されなかった。また、延べ7個のザクロ果実を調べた結果でもエストロゲンが含有されていることの確認はできなかった。またザクロの種子に含まれていた植物ホルモンのクメステロールも健康志向食品からは検出されなかった。 独立行政法人国民生活センターの概要 (情報公開法第22条に規定する情報の提供) 国民生活の安定及び向上に寄与するため、総合的見地から、 国民生活に関する情報の提供及び調査研究を行うこと。
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Other Estrogen Alternative - (3) Black Cohosh
Vulnerability of Black Cohosh The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) advised that a warning label would be placed on the all black cohosh products due to 21 reported cases of liver problems associated with black cohosh use (MHRA, 2006) 01/15/2007 07/30/2007 At the end of one year, there was no significant difference seen between the number of daily hot flashes and/or night sweats in any of the herbal groups compared to the placebo group, with an average of 0.6 less vasomotor symptoms per day in the herbal groups. There was a significant difference-4.06 fewer symptoms per day-in the hormone therapy group compared to the placebo groups The committee reviewed case reports suggesting a potential link between ingestion of the extracts and liver damage
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Other Estrogen Alternative - (3) Black Cohosh
As of Oct 2012, due to 36 out of 53 case reports related to black cohosh involved liver problem, MHRA has warned manufacturers of black cohosh products that the herbal supplements must contain warnings about potential liver problems (MHRA 2012).
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Other Estrogen Alternative - (4) Isoflavone
Genistein (a major isoflavone aglycone) may cause Cancers (NIH & FDA – National Toxicology Program, Genistein Final , Jan, 2008) Exposure to Genistein for 2 years caused mammary gland /pituitary gland adenoma in female rats. Exposure to Genistein for shorter duration following birth was also possibly associated with increased rates of pituitary gland and mammary gland tumors. Cancer Causing Risks Isoflavone Could be Toxic because its high level of hormone-like action. It could be Hormone Dependent Cancer Causing Material due to its high binding affinity to Estrogen Receptor α, and β Relative Binding Affinity α β Estradiol 100 Coumestrol1) 94 185 Genistein2) 4 87 1) Kuiper et al, Vol 139, No. 3, Endo ) Vol 138, No. 10, Endo 1998,
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EstroG-100’s Superiority over Others
Pomegranate Soy Isoflavone Black Cohosh HRT Improved Symptoms 10 1 (Hot Flush) X Partially Some Improved Improvement of vaginal dryness O Bone metabolism index Bone density O (FBMD) O (Spine) Triglycerides Side Effects Cancer Related (limitation on dosage) Liver Damage Fatal Side Effects Increase of Body Weight & BMI - E2, FSH Changes Development In the 2000s In 1998 In the 1990s In the 1940s Related Patents 17 registered and pending patents
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Estrog C. Science of Estrog-100
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EstroG-100 (1) Science of New Herbal Ingredient Proven Safety
About 400 years of documented use in Korea as folk medicine Registered as safe food ingredient in Korea Food Code Cynanchum wilfordii & Phlomis umbrosa are reported to be liver-protective plants to WHO No increase of uterus weight in ovariectomized rat tests Inhibition of proliferation of human breast cancer cell (MCF-7) No binding Affinity to both Estrogen Receptor α and β, Safe: Acute & Multi-dose toxicity tests , Genetic toxicity tests Proven Efficacy in vitro, in vivo, and in 3 human group (Asian and non-Asian) clinical studies Herbal extracts screened out of 71 herbal extracts via non-reproductive tract target tissue response (E-screen test) 3 herbal extracts were chosen: Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas nakai
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Improve Menopausal Symptoms
EstroG-100 (2) Clinically proven efficacy : 62% significant improvement of QOL 10 out of 12 climacteric symptoms significantly improved compared to Placebo Improve Menopausal Symptoms Hot flash/ Night Sweats Paresthesia Insomnia Nervousness Melancholia Vertigo Fatigue Rheumatic pain Formication Vaginal Dryness 62% Improvement of symptoms
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Clinical Study I Protocol Efficacy Clinical Study I
Test Method Randomized Double-blind Placebo-controlled study Study Location School of Medicine, Sungkyunkwan Univ. Samsung Cheil Hospital Dosing period 12 months (May 2003-April 2004) Evaluation Style Long Term Safety Evaluation Patients (n=47) 23 subjects in placebo group & 24 active group Inclusion Criteria Age of 46 ~ 66 & Diagnosis of menopausal syndromes (average age=54) Efficacy Climacteric Symptoms 5 times better improvement than placebo with significance Climacteric Symptoms 5 times better improvement than placebo with significance After 3 months OR=5.04 (95% C.I.= ) Fisher’s Exact Test Femoral Bone Mineral Density 0.746±0.10 → 0.763±0.13 (P<0.05) Serum hGH Level 0.25±0.21 → 0.92±0.97 (ng/mL) (P<0.05) Serum Osteocalcin Level 6.02±2.74 → 5.66±3.01 (ng/mL) (P<0.05) Serum Triglyceride Level 119.1±54.72 → 92.16±49.94 (mg/dL) (P=0.066) Serum Alkaline Phosphatase Level 73.35±21.02 → 60.42±14.87 (IU/L) (P=0.08)
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Clinical Study II - Protocol(Non-Asian)
Randomized, Double-blind, Placebo-controlled Study (CA, USA) Dosing period 3 months Patients (n=61) 32 subjects in placebo group & 29 active group Inclusion Criteria Age of 42 ~ 70, Diagnosis of menopausal syndromes(average age = 53) Ad for Volunteers for US Clinical Study
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Clinical Study II – Result (1)
Efficacy of EstroG-100 Kupperman Menopause Index and Vaginal Dryness (Difficulties in Sexual Intercourse) Improved Significantly Somatic / Physical: Hot flush/ Night sweat Paresthesia (numbness on hands/foot) Vertigo (dizziness) Fatigue Muscular skeletal pain Physiological / Psychological: Nervousness Insomnia Depression Formication Vaginal Dryness (Difficulties in Sexual Intercourse) EstroG-100 was confirmed to improve both somatic and physiological symptoms with statistic significance.
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Clinical Study II – Result (2)
Vaginal Dryness Vaginal Dryness Improved Unlike Black cohosh and Isoflavone EstroG-100 Mean±SE Placebo Week0 (Baseline) 1.45±1.02 1.75±1.11 Week6 Change from baseline 0.72±0.88 -0.72±0.84**††## 1.50±1.11 -0.25±0.57# Week12 0.59±0.87 -0.86±0.88*## 1.28±1.02 -0.47±0.72## P=0.0536 Vaginal dryness scores Fig. 1. Changes of vaginal dryness and reduced libido during 12 weeks administration of EstroG-100 and placebo. SE: Standard Error *: Statistically significant compared between groups; p<0.05 by t–test(ITT) **: Statistically significant compared between groups; p<0.01 by t–test(ITT) ††; p<0.01 compared between groups by Wilcoxon rank sum test #; p-<0.05 compared to baseline, ##; p<0.01 compared to baseline by paired t-test
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Clinical Study II – Result (3)
KMI Kupperman Index for Moderate or Severe Menopausal Symptoms Improved EstroG-100 Mean±SE Placebo Week0 (Baseline) 29.45±7.39 29.16±6.55 Week6 Change from baseline 13.62±7.61 -15.83±9.10**††## 23.31±8.96 -5.84±6.15## Week12 11.31±5.78 -18.14±8.46**††## 23.66±7.68 -5.50±5.34## Kupperman index scores Time (weeks) Fig. 2. Changes of Kupperman Menopause Index(Mean±SE) during 12 weeks administration of EstroG-100 and placebo. SE: Standard Error **: Statistically significant compared between groups; p<0.01 by t–test(ITT) ††; p<0.01 compared between groups by Wilcoxon rank sum test ##; p<0.01 compared to baseline by paired t-test
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Clinical Study II – Result (4)
Individual Menopausal Symptoms EstroG-100 (n=29) Placebo (n=32) Week 0 Week 6 Week 12 Vasomotor 2.24±0.69 1.03±0.82**††## 0.79±0.73**††## 2.22±0.66 1.78±0.75## 2.06±0.76 Paresthesia 1.31±0.85 0.59±0.78*†## 0.55±0.74*†## 1.41±0.91 1.13±0.94# 1.09±0.96## Insomnia 2.28±0.84 1.28±0.96**†## 0.97±0.82**††## 2.03±0.86 1.63±1.01# 1.63±0.87# Nervousness 1.72±0.88 0.76±0.69**††## 0.66±0.67**††## 1.56±0.84 1.22±0.83 1.34±0.75 Melancholia 1.93±0.88 1.03±0.68**††## 0.83±0.71**††## 1.59±0.95 1.31±0.93 1.31±0.74 Dizziness 0.97±0.82 0.21±0.49**††## 0.21±0.41**††## 0.75±0.72 0.72±0.77 0.59±0.80 Fatigue 2.21±0.77 0.90±0.77**††## 0.72±0.70**††## 2.00±0.88 1.69±0.90# 1.59±0.80# Arthritic Pain 1.59±1.02 0.79±0.94**†## 0.55±0.78*†## 1.84±0.95 1.63±0.83 1.47±0.88 Headache 1.34±1.04 0.69±0.76## 0.66±0.77## 1.53±0.95 1.13±0.91# 0.84±0.72## Palpitation (heart poundering) 1.00±0.96 0.48±0.69# 0.55±0.63# 0.91±0.82## 0.75±0.84## Formication 0.83±0.85 0.14±0.44* ## 0.28±0.45## 1.25±1.05 0.88±1.01## 0.72±0.96## *; p-<0.05 compared between groups, **; p<0.01 compared between groups by t –test †; p-<0.05 compared between groups, ††; p<0.01 compared between groups by Wilcoxon rank sum test, #; p-<0.05 compared to baseline, ##; p<0.01 compared to baseline by paired t-test
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Clinical Study III - Protocol
Test Method Multi Center, Randomized double-blind placebo-controlled study Study Location Aju University Medical Center Anam Hospital of Korea University Severance Hospital of Yonsei University Test period 12 weeks Dosage 638 mg tablet orally twice a day Study Participants 96 female participants of age of 40~70 with menopausal symptoms Inclusion Criteria Age of 40 ~ 70 with menopausal symptoms
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Clinical Study III - Result
Significantly Improved! Hot flash Paresthesia Nervousness Melancholia Vertigo Fatigue Formication Rheumatic pain Vaginal Dryness The result almost duplicate the 2nd Clinical Study (Non-Asian) by improving as many as 10 different symptoms. No significant differences or changes observed when measured endometrial thickness. No change in weight, BMI, and the level of estrogen and FSH without any adverse event reported during the study. The endometrial thickness was measured to be observed not to change in addition.
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Efficacy of EstroG-100 (1) Estrogenicity
In e-screen test, the estrogen-specific alkaline phosphatase has significantly increased and synergetic effects of EstroG-100 has been confirmed E-screen test: Screen herbal extracts for Estrogenicity Synergetic Effects of 3 Constituent herbal extracts confirmed Lee at al., Lab. Anim. Res. 24(2): (2008) Uterus weight Serum osteocalcin FBMD Significantly improved in serum osteocalcin and FBMD in OVX rat No change in weight, liver, kidney, and uterus weight in OVX rat Kim at al., Kor. J Food Sci. Technol. 40(3): (2008)
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Efficacy of EstroG-100 (2) 75% higher satisfaction rate compared to the existing Isoflavone product 69% picked “Better Efficacy” for the top reason for the higher satisfaction * One month Open Label Clinical Study by HiLiving, the No.1 MLM firm among local capital MLM companies in Korea with 119 participants
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Efficacy of EstroG-100 (3) 86% decrease in menopausal symptoms compared to 39% of the Isoflavone product Sales volume increased 2.5 times, satisfaction/repurchasing/ recommendation rate soared * One Month Open Label Clinical Study by Pulmuone Health Care with 31 participants
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Efficacy of EstroG-100 (4) Wrinkles, Hot Flashes, and Moisture Significantly Improved * One month Open Label Clinical Study by LG Household & Health Care for 6 weeks with 30 participants
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Restarting menstruation
Efficacy of EstroG-100 (5) Symptoms Cases % Hot flush 11 20% Paresthesia 4 7% Insomnia 3 6% Nervousness Melancholia Vertigo Fatigue 5 9% Rheumatic pain Formication 2 4% Headache Palpitation Vaginal dryness 7 13% PMS Menstrual pain Restarting menstruation 1 2% Total 54 100% Hot flush and vaginal dryness, 33 % of total improved cases. Out of 20 participants, 10 participants showed the improvement of menopausal symptoms within 7 days after taking EstroG-100. The main improvement symptoms were hot flush and vaginal dryness, 33 % of total improved cases. * Open Label Clinical Study by Kim Jung Moon Aloe for 4 weeks with 20 participants
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Safety of EstroG-100 (1) Safety in 3 human clinical studies
No serious adverse effects – not even a single case of vaginal bleeding / spotting No change in uterus weight, body weight and BMI (while bone mineral density increase) None of serious side effects reported in 3 clinical studies without E2, FSH level change No change in blood pressure, blood sugar, cholesterol, LDL/HDL No change in endometrial thickness Other Proven features All three herbs have been documented for use as herbal remedy for +400 years in Korea All three herbs are registered in Korea Food Standard Codex as main food material Cynanchum wilfordii and Phlomis umbrosa are reported to be liver protective herbs by WHO
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EnBio Estrogen Receptor / Coactivator, Ligand Assay System
Safety of EstroG-100 (2) MCF-7 proliferation inhibition Inhibitory effect of proliferation of human breast cancer cell line (MCF-7) Estrogen receptor binding affinity test No binding affinity to both ERα & ERβ in estrogen receptor binding affinity study EnBio Estrogen Receptor / Coactivator, Ligand Assay System
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Safety of EstroG-100 (3) Toxicology Single oral toxicity study
No specific toxic symptoms in relation to test substance were observed Minimal lethal dose (MLD) > 4,000 mg/kg (HED = 648.6mg/kg) Thirteen-week repeated (91 day) oral dose toxicity study of in Sprague-Dawley rats No observed adverse effect level (NOAEL): upward 1,000 mg/kg in the male and female group Genetic Toxicity Study – proven non-toxicity Ames (Bacterial Reverse Mutation), Micronucleus, Chromosome Aberration
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Mechanism of Action (1) EstroG-100:
There are 4 different traditional methods of screening candidate plants for estrogenecity. E-screen assay to see non-reproductive tract target tissue response for a certain plant extract to induce alkaline phosphotase or ALP √ confirmed Reproductive tract response for a certain plant extract to change uterus weight of ovariectomized rats (now, just for safety) √ confirmed Receptor binding affinity test (now, just for safety) √ confirmed Gene reporter vector assay (now, just for safety) EstroG-100: In a non-reproductive tract target tissue response for e-screen assay, all of the 3 constituent herbal extracts of EstroG-100 found to promote estrogen-specific ALP activity to show estrogenic action while EstroG-100 promoted more than any of the individual herbal extract (Lee et al. Anti-menopausal effect of the newly-developed phytoestrogen, FGF271 (=EstroG-100), in vitro and in vivo. Lab. Anim. Res. 24(2): (2008).) In the earlier study that has not been published, the 3 constituent herbal extracts of EstroG-100 were selected out of 71 different herbal extracts by this e-screen assay.
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Mechanism of Action (2) Even though the exact mechanism has not been clarified, the following available evidences suggest that some phytochemicals in EstroG-100 act as estrogen agonists and/or antagonists without influencing the levels of estradiol (E2) and follicle stimulating hormone or FSH: In two researches for the reproductive tract target tissue response, EstroG-100 did not increase the uterus weight of ovariectomized rats while it increased femoral bone mineral density. (Kim et al. Korean J. Food Sci. Technol., 2008 and Lee et al. Lab. Anim. Res. 2008) EstroG-100 did not show any affinity to both estrogen receptor alpha and beta in the receptor binding affinity test reported by Chungbuk National Univ. of South Korea Each herbal extract of EstroG-100 showed inhibitory effect of the proliferation of human breast cancer (MCF-7) cells In three randomized double-blind placebo controlled clinical study, EstroG-100 improved menopausal symptoms without any serious side effects with no increase of body weight and BMI and without influencing level of E2 and FSH (Lee et al. Evaluation of effectiveness and safety of natural plants extract (Estromon(=EstroG200)) on perimenopausal women for 1 year. J of Korean Society of Menopause. 11(1): (2005) In other clinical study performed in U.S. that was finished on Feb. 2010, EstroG-100 significantly improved menopausal symptoms of non-Asian American women without any side effect (Chang et al. The Effect of Herbal Extract (EstroG-100®) on Pre-, Peri-, and Post-Menopausal Women: A Randomized Double-Blind Placebo-Controlled Study. Phytother. Res. 26: (2012)).
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EstroG-100 D. Approvals & Licenses
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Approvals & Licenses (NDI)
NDI Notification Accepted by US FDA (2010) EstroG-100 is listed as New Dietary Ingredient ※ The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” which has not been distributed in USA market before 1994, notify the Food and Drug Administration about these ingredients. Generally, the notification must include information that is the basis on which manufacturers/ distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. The NDI notification process is complex. NDI notifications are most often rejected due to insufficient evidence for safety, the absence of required elements, as well as lack of knowledge and experience for such notifications.
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Approvals & Licenses (NPN)
NHPD Product License, Health Canada (2011) According to Health Claim, 10 Symptoms Improved! Approved Claims with No Side Effects According to Health Claim, 10 Symptoms Improved! Date of License: July 5, 2011 Natural Product Number(NPN): Helps to relieve the symptoms associated with menopause such as hot flashes, night sweats, paresthesia(numbness on hands/foot), insomnia, nervousness, melancholia(depression), vertigo(dizziness) , fatigue, rheumatic pain and vaginal dryness. Risk Information: None.
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Approvals & Licenses (HFFI)
Health Functional Food Ingredient (HFFI) Approval by MFDS (Korea FDA) (2010) Approval No: Claim: Help with climacteric women’s health EstroG-100 is the first approved ingredient in Korea as Health Functional Food Ingredient by KFDA for alleviating menopausal symptoms such as hot flashes, night sweats, paresthesia(numbness on hand/foot), insomnia, nervousness, melancholia(depression), vertigo(dizziness), fatigue, rheumatic pain and vaginal dryness and formication
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EU Approval Status N O W Received Positive Assessment by Irish Authority ~ EU Member States reviewed the Irish Authority’s opinion Final comments submitted to EU Member States for assessment on novel food approval for EstroG-100 Expecting to obtain Novel Food Approval
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China Approval Status N O W Initiated branch establishment 2013.09
Established branch in China Partner with Registration Agency Delivered Samples for Examination Applied for trademark for EstroG Requested to examine product to authorized health food inspection institution Technical Review by CFDA ~ ~ Administrative Review by CFDA Decision Delivery by Administrative Service Center ~2016 N O W
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Estrog-100 e. Products & Partners
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Major Products & Partners
Supplying Ingredients for Global Clients in S. Korea, U.S., Canada, Singapore, Malaysia, Thailand Major Products Major Partners (Domestic) EstroG Finished Goods EstroG ODM BAEKSUO GOONG (GS Home Shopping, Home & Shopping,,, Hyundai Home Shopping) BAEKSUO QUEEN (Lotte & CJ Home Shopping) Donga BAEKSUO (Donga Pharm) EstroG Ingredients Major Partners (Overseas) NU SKIN (ESTERA Ⅱ) HERBALIFE (Healthy Woman EstroG) KGC (Hwaaelak Queen) Walgreens (Menopause Relief) CVS (Menopause Relief) DR’S BEST (Best EstroG-100) NOWFOODS (Herbal Pause)
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Products (US) Multi Symptom Menopause Relief (Walgreens)
8 Symptom Advanced (CVS Pharmacy) Herbal Pause (NOW Foods) Best EstroG-100 (Doctor's Best) Advanced Natural Sex for Women 50+ (Life Extension) Ultra EstroG-100 (Swanson) Profemin (TheraBotanics LLC) Intimate Comfort (Healthy Directions ) Zestrogen (Purity Products) Advanced 8-Symptom Menopause Relief (Meijer) Venus and Mars (Dr. John Gray, Inc.) EstroPrime Plus (Allergy Research Group) Flashes No More (Nutricology) n-fuzed Estro-Fem (Harmonic Innerprizes Inc) HerbaEst Balance (New Spirit Naturals)
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Estrog-100 F. In-house Manufacturing Facility
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In-house Manufacturing Facility
Securing supply of raw ingredients for GMP level manufacturing through contract farming Contract Farming for EstroG Raw Material Completed Construction of GMP Facility (September 2014) Expected effect from in-house production Strict control over quality Profit increase by reducing production cost Secure sustainable supply of ingredient through increase in Capacity Stable supply of ingredients through contract farming Capacity Secure raw material supply through contract farming (Ton) 300 300 Easy to grow & harvested annually in autumn. In-house CAPA Total High resistance to decay 160 120 In-house low temperature warehouse to ensure the best quality of raw materials * In-house Production Capa of 10 ton/month
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Estrog-100 G. MEDIA Coverage
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Media Coverage (1) EstroG-100® was mentioned on national Canada TV show, Steven and Chris on January 22nd, 2015.
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Media Coverage (2) SBS Special : Rediscovery of Korean Herb (Mar. 3rd , 2013) The most popular privately owned TV channel, SBS Special Documentary featured EstroG-100 for 1 hour: its history, science & technology, testimonials from MDs and end users, and other distinctive aspects. “Traditional Korean herb extracts pulling Global attention and being exported to the World. KBS Science Café – Science of Hormone (April 9th, 2012) The largest and state-run Korea Broadcasting System or KBS reported on hormone in their program called Science Café. It dealt the science of hormone and introduced EstroG-100 as a safe new product for menopause.
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TV Commercial featuring on TV Commercial featuring on
Media Coverage (3) TV Commercials & Others TV Commercial featuring on KBS and MBC SBS News Health Report(July, 2012) TV Commercial featuring on KBS and MBC MBC Power Magazine(Oct., 2012)
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Press Coverage (1) Life Extension Magazine, May 2012
“EstroG-100™, this multi-compound extract supports balanced estrogenic activity, which in turn inhibits the many symptoms of menopause including female sexual dysfunction”
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Press Coverage (2) 세계 각국 우량 협력업체
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Home Shopping & Infomercial
Launched through 5 Major Home Shopping Channels in Korea Launched through infomercial in US in June 2014
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Estrog-100 H. Awards
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Awards (1) 2014 Bronze Tower Industrial Order (Presidential Award),
Korea Creative Economy Expo Awarded Presidential Bronze Tower Industrial Order Service Merit, in recognition of contribution to the development of industry and the national economy.
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Awards (2) Best Botanical Award at Natural Products Expo West in US (2014)
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Awards (3) Korea’s Top 10 Most Innovative Technologies (2013)
Korean World-class Product Award (2011) EstroG-100 was awarded for “Korea’s top 10 innovative technologies” in This award is given only for the product that is the most promising and potential of the year in all industry. World-class Product Award is honorable recognition given to top-tier Korean companies including Samsung, Hyundai, and LG. For ‘EstroG-100’ by Ministry of Trade, Industry and Energy For ‘EstroG-100’ by Ministry of Knowledge & Economy
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Awards (4) Presidential Citation (2011)
In recognition of the company’s integrated contribution to the growth of the industry through edge-state technology development in agro-fishery food sector.
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Awards (5) IR52 Chang Young-Sil Award(2009)
This Award is normally and in most cases for conglomerates such as Samsung, Hyundai, LG, and for the suppliers for the big companies from Ministry of Education, Science and Technology (2009).
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Korea Health Industry Award by KFDA 2009 Health Technology Award 2008
Awards (6) Korea Health Industry Award by KFDA 2009 Health Technology Award 2008
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Awards (7) Product Merit Award-NBJ (2006)
Awarded to the Promising Brand-new Functional Food of the Year
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Awards (8) Gold Medal Prize in the Exhibition of Inventions of Geneva (2008) The International Exhibition of Inventions of Geneva is one of the three largest invention expo in the world.
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Estrog-100 I. Miscellaneous
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Product type-Examples (1)
Baeksuo Gung Baeksuo Secret Outer Packing 1 paper box Inner 4 inner boxes 2 inner bottles Contents 6 soft gels/Blister 5PTPs/inner box Total 500mg x 120 capsules (1 month) 56 tablets/bottle Total 500mg x 112 tablets (2 months) Dosage 4 capsules per day 2 tablets per day Formulation Types Soft gels Coated tablet MOQ
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Product type-Examples (2)
8 Symptom Advanced Menopause Relief (CVS) Multi Symptom Menopause Relief (Walgreens) Hwang Hoo Baeksuo Outer Packing 1 paper box Inner - 2 inner boxes Contents 20 capsules/box Total 514mg x 28 capsules (1 month) 30 spout pack bags/inner box Total 80g x 60 packs Dosage 1 capsule per day 2 packs per day Formulation Types Hard capsule Beverage MOQ
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Product type-Examples (3)
Baeksuo Hyoso Baeksuo Queen Outer Packing 1 paper box Inner 2 paper boxes Contents 30 packs/box Total 3g x 60packs (1 month) 14 packs/box Total 22g x 28packs Dosage 2 packs per day 1 pack per day Formulation Types Sachet powder Jelly type MOQ
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Product type-Examples (4)
EstroG-100 Outer Packing 1 bottle Inner - Contents 615mg x 60 capsules (1 month) 700mg x 60 tablets Dosage 2 capsules per day 2 tablets per day Formulation Types Hard capsule Tablet MOQ
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www.naturalendo.com Naturalendo Tech Co., Ltd.
3rd Floor, Bldg A. C’s Tower, 58, 255 St., Pankyo-ro Bundang-gu, Seongnam-shi, Gyeonggi-do, Korea
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