Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that...

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Transcript of Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that...

Page 1: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.
Page 2: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Biotechnology that Changes The Future

Page 3: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Overview

CEO Message

History

Performance

Global Network

Products

R&D

Plants

Contact Information

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Medytox Bldg., 626, Teheran-ro, Gangnam-gu, Seoul, Republic of Korea

Page 4: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Medytox is a biopharmaceutical company that changes the future

USD 2.6 million2016

USD 111.9 million 2016

USD 2.2 billion2017. 02

450 employees2016. 12

Capital

Revenue

Market Capital

Headcount

Overview

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Page 5: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Global Biopharmaceutical Company

Pioneer of Biopharmaceutical Industry

Export of botulinum toxin type A and HA filler products to over 60 countries

Development of the next generation biopharmaceutical products

Penetration into advanced markets such as US and EU

The only biopharmaceutical company in the world to have three different types of botulinum toxin products (Neuronox®, INNOTOX®, Coretox®), all developed by in-house R&D

I. First company in Korea and fourth company worldwide to develop a botulinum toxin type A product

II. Development of the world’s first liquid formulation of botulinum toxin type A product with no animal-derived ingredients

III. Development of purified botulinum toxin type A product, which contains only the core active ingredient, and no animal-derived substances

Development of various hyaluronic acid dermal filler

Out-licensing of the new formulation botulinum toxin type A product to Allergan Inc. (Deal size: $362 million)

Disclosure of the entire genome sequence of strain of Clostridium botulinum at Medytox for the first time in botulinum toxin market

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Seoul Medytox Bldg. Medytox Korea Office

Gwanggyo R&D Center

Pangyo R&D Center

Gwangju Branch Office

Daejeon Branch Office

Osong Plant II, Plant III, R&D Center

Daegu Branch OfficeBusan Branch Office

Medybloom China*

MedyCeles*(Thailand)

Medytox US(Maryland)

Medytox Japan (MDT International, Tokyo)

Medytox Taiwan*

Medytox Hong Kong*

* Joint Venture

Establishment2 May 2000

OverseasMedytox US (Maryland) Medytox Japan (MDT International, Tokyo)MedyBloom China*Medytox Taiwan*Medytox Hong Kong*MedyCeles (Thailand)**Joint Venture

DomesticOchang (Headquarter /Plant I) Osong (Plant II, Plant III, R&D Center) Seoul (Medytox Bldg.)Pangyo, Gwanggyo (R&D Center) Medytox Korea (Seoul, Busan, Daegu, Daejeon, Gwangju)

Ochang Headquarter / Plant I

Overview

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Page 6: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Greetings!

Medytox has grown by pushing for innovations and continually challenging ourselves. As the first botulinum toxin developer and the market leader in Korea, we feel a sense of pride and responsibility for this industry, which is why we are leading the efforts to improve the transparency and the competitiveness of the Korean biopharmaceutical businesses by pushing for implementation of more objective and scientific guidelines for industry practice.

Additionally, by maintaining its focus on continual in-house R&D, Medytox has developed three different types of botulinum toxin products, Neuronox®, INNOTOX® and Coretox®, each with its own unique strengths. Along with these products, Medytox has introduced Neuramis®, successfully solidifying a new pipeline of dermal fillers.

President & CEO Hyun ho Jung

In 2016, Medytox exceeded the 100 billion KRW mark in total annual sales for the first time since its founding. Neuronox® has become the No.1 product in its category in both Japan and Thailand, followed by Korea market. Last December, KGMP and product approval (Neuronox® for export) for plant III were obtained, relieving the supply constraint concern.

Neuramis® also has contributed to the rapid growth in sales. Since its launch in 2013, sales of Neuramis® have reached over 4 million in quantity, proving its efficacy and safety, and establishing itself as reputable product in the global market.

Medytox, as a company striving to change the future, has set a new goal of entering the Top 20 list of biopharma companies by 2022. In order to achieve this goal, everyone at Medytox is stepping up their efforts to tackle the advanced markets as well as expand the direct penetration of emerging markets. Additionally, we will continue to increase the R&D investment, develop new businesses, and always seek new acquisition opportunities to create synergy.

Medytox will continue to live up to our reputation as innovators in the biopharma industry, and in all aspects of our business. We are committed to maintaining high standards worthy of global recognition. We sincerely ask for your continuous support, love and encouragement. Thank you.

My name is Jung Hyunho, and I’m the CEO of Medytox. Thanks to your support, Medytox has expanded beyond domestic boundaries and is now one of the premier companies in the global botulinum toxin market. For this, I would like to express my sincere appreciation and gratitude. CEO

Message

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Page 7: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Completed Medytox Plant II(Osong) Construction (cGMP/EU GMP) Selected as the K-Brain Power Company by the Ministry of Trade, Industry and Energy Obtained Marketing Approval from MFDS for Neuramis® Deep Lidocaine

Established Medytox Korea (Subsidiary for local sales) Opened Medytox US Office Obtained Marketing Approval from MFDS (Formerly KFDA) for Neuramis® Deep Signed a License Agreement with Allergan for the New Formulation Botulinum Toxin Products (Currently in Development) Obtained Marketing Approval from MFDS for Neuronox® 150U Obtained Marketing Approval from MFDS for INNOTOX®

Established Joint Ventures, including Medytox Taiwan, MedyBloom China, Medytox Hong Kong Established Medytox Japan(MDT International), a subsidiary in Japan Obtained Marketing Approval from MFDS for Neuramis® Lidocaine Series Obtained Marketing Approval from MFDS for INNOTOX® 50U

Obtained Marketing Approval from MFDS for Coretox® 100U Received $30M Export Tower Award from the Ministry of Trade, Industry and Energy Obtained KGMP Approval for Medytox Plant III(Osong)

Selected as an Advanced Technology Center(ATC) by Ministry of Knowledge Economy Obtained KGMP Approval for HA Dermal Filer facility in Medytox Plant I Received CE marking (Conformité Européenne) for Neuramis® Deep

Selected as ‘Innovative Pharmaceutical Company Accreditation’ by the Ministry of Health & Welfare

Obtained Marketing Approval from KFDA for Neuronox® 50U

Listed on KOSDAQ Obtained Marketing Approval from KFDA for Neuronox® 200U Achieved No.1 Market Share in the Botulinum Toxin Market in Korea

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HistoryHistory

Relocated to Medytox Bldg. (Seoul) Established MedyCeles, a JV in Thailand Completed Medytox R&D Center (Gwanggyo) Construction

History

Obtained KGMP Approval for Medytox Plant I(Ochang)

Medytox Established

Selected as ‘Bio Star Enterprise’ by the Ministry of Knowledge Economy

Opened Medytox Seoul office

Obtained Marketing Approval from KFDA for Neuronox®

Selected as ‘World-class product’ for Neuronox® by the Ministry of Industry and Resources

Established the Microbial Toxin R&D Center at Medytox

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Since botulinum toxin type A Neuronox®(being sold worldwidely under different brand names such as Siax®, Botulift®, Cunox®, Tonytox® and Meditoxin®) was launched in 2006, Medytox has shown a dramatic growth. Since 2009, Medytox has ranked No.1 in its market share in Korea and reached nearly 40% of market share. As additional efficacies are discovered, it is predicted that the market share will increase even further.

The global botulinum toxin market has been on the rise (approximately 13.4% growth per year). It is likely that botulinum toxin market will further expand to therapeutic market as well as medical aesthetics market. Even though Medytox is considered a new player, it has surprised many with a significant market share gain in a short time.

Medytox, as a company striving to change the future, has set goals of achieving 1 billion dollars in sales and entering the Top 20 list of biopharma companies by 2022.

To that end, Medytox is stepping up its efforts to tackle the advanced markets as well as expand the direct penetration of emerging markets. Additionally, we will continue to increase the R&D investment, develop new businesses, and seek new acquisition opportunities to create synergy.

1 Billion dollars turnover in sales in 2022, Ranked 20th in Global Biopharmaceutical Industry

Performance

Medytox is the only biopharmaceutical company in the world to have three different types of botulinum toxin products (Neuronox®, INNOTOX®, Coretox®), all developed by in-house R&D.

Performance

Recent 5 Years Result SalesOperating Income

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(Unit: 100million KRW)20132012 2014 2015 2016 Year

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Operating Income Ratio

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Since the successful development of the fourth botulinum toxin type A product in the world, Medytox has continued moving forward by establishing a presence in medical aesthetics as well as therapeutic indications, associated with movement disorder and it continues to innovate.

Medytox was able to launch a HA Filler Neuramis® Series, which could generate synergy with botulinum toxin products, and also launched the world’s first liquid formulation botulinum toxin type A product INNOTOX® in Korea and Japan. Medytox also has obtained Coretox® marketing approval in 2016, which is the 3rd botulinum toxin type A product for the company.

Medytox has raised the bar for the Korean biopharma industry by signing a $362million out-license contract with Allergan, maker of Botox, in September of 2013.

Medytox exports its products to over 60 countries including Japan, Brazil, Thailand and Iran. Moreover, Medytox is making efforts to penetrate the US and European market in the near future. Ultimately, Medytox is working ceaselessly with the goal of becoming a leading global biopharma ceutical company.

Recently, Medytox has started shifting its gear, from indirect penetration through local agent basis export to direct market penetration for overseas expansion, and has set up several joint ventures, including Medytox Taiwan, Medybloom China, Medytox Hong Kong, and MedyCeles in Thailand respectively, as well as a subsidiary, ‘MDT International’, in Japan. The new penetration strategy is expected to bring more growth and profitability in the global market.

Global Network

Medytox, an R&D based global biopharmaceutical company, engages in the development, manufacturing, marketing and sales of botulinum toxin and hyaluronic acid dermal filler products as its main business.

Global N

etwork

Registration Status of Neuronox® and Neuramis® (2017. 03)

Asia America Europe

AerbaijanGeorgiaHong KongIndiaIranKazakhstanKoreaKyrgyzstanMyanmarMongoliaLebanonPhilippinesSyriaThailandUzbekistanVietnam

BoliviaBrazilChileColombiaCosta RicaDominica RepEquadorEl SalvadorGuatemalaMexicoNicaraguaPanamaParaguayPeru

UkraineEstoniaSpainBelarus

Neuronox® and Neuramis®

Neuronox®

Neuramis®

Registered Countries 1514

Page 10: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

INNOTOX® is the world’s first liquid formulation of botulinum toxin type A product, developed and launched in 2014.

INNOTOX® is an innovative product which has been developed by totally excluding animal-derived ingredients and human serum albumin in order to enhance product safety. At the same time, it is easy to prepare since no dilution is necessary for administration.

Currently INNOTOX® is being sold in Korea and Japan and it is emerging as the product to show our distinguished R&D capabilities.

The Innovation of Botulinum Toxin Type A

Products

Products

Ref 1. H Kang et al. Plast Reconstr Surg. 135:732-741. 2015

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1 The World's First Liquid Formulation of Botulinum Toxin Type A

The world’s first liquid formulation of botulinum toxin type A product with no animal-derived ingredients.

User Friendly

Enhanced user convenience without dilution process, which minimizes potential hygiene problems.

Proven Efficacy & Safety

Efficacy and safety proven in clinical study. Ref1

Accurate Dose

Exact dose for injection.(INNOTOX® 0.1mL = 4unit)

Rx Only

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Neuronox® is Korea’s first and the fourth botulinum toxin type A product in the world, launched in 2006.

Neuronox® is a representative botulinum toxin type A product of Medytox that is being exported to over 60 countries. Neuronox® ranks No.1 in market share in Korea and has gained significant market share in many other countries. (Being sold worldwide under different brand names including Siax®, Botulift®, Cunox®, Tonytox® and Meditoxin®)

Neuronox® offers choices by providing a range of product units including 50, 100, 150 and 200.

Backed up by efficacy and safety proven through clinical trials, Neuronox® has recently reached the sales of over 5 million vials*, and the sales is still steadily growing.

* Figures from Medytox (2016. 04)

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Proven Efficacy & Safety

Efficacy and safety proven in clinical studies, with results published in distinguished academic journal such as Dermatologic Surgery.

Global Product

Neuronox® has been sold in over 60 countries, since its first launch in 2006. Neuronox® is being sold worldwide under different brand names, such as Siax®, Botulift®, Cunox®, Tonytox® and Meditoxin®.(Registered in 30 countries, Registration in progress in 30 additional countries)

Various choices

Neuronox® line consists of 50, 100, 150 and 200 units, offering various choices according to the application. Physicians find it easier to use and the patients, more economical.

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The First Choice of Botulinum Toxin Type ARx Only

Products

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The New of Botulinum Toxin Type A

Medytox has obtained Coretox® marketing approval in 2016, which was developed as the 3rd botulinum toxin type A product for the company.

Coretox® is an advanced new botulinum toxin type A product that excludes animal derivatives, HSA and non-toxin proteins from its ingredients. It prevents the immune system from developing antibodies that would eventually wear down the effects of botulinum toxin type A.

Products

Rx Only

Products

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Page 13: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Neuramis® is the hyaluronic acid dermal filler product developed and launched in 2011.

The Neuramis® series Neuramis® Meso(Export Only), Neuramis® Light Lidocaine, Neuramis® Lidocaine, Neuramis® Deep, Neuramis® Deep Lidocaine, Neuramis® Volume Lidocaine which can be used to add volume and fullness to the skin to correct moderate to severe nasolabial folds, the lines from your nose to the corners of your mouth.

Neuramis® Deep attained CE mark in 2011 and other series are in the process as well.

Products

Medical Device

The Smart Choice of Hyaluronic Acid Dermal Filler

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1 Enhanced Safety

Using high quality hyaluronic acid registered in FDA and EDQM raw materialsEnhanced safety through enhanced purification process and final sterilization process.

Long lasting Effect

Enhanced durability of effect by performing double crosslinking

High Satisfaction

High customer satisfaction with its ability to maintain a natural look after injection

Easy to use

Ideal properties developed scientifically, giving rise to even extrusion forceSmooth and even flow to minimize pain and enhance convenience of injection

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Page 14: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

R&D

Botulinum toxin, one of the neurotoxins produced by Clostridium botulinum, is known as the most toxic substance in nature. It is widely used not only in the medical aesthetics field, including facial wrinkle reduction, but also in the therapeutic field for patients with blepharospasm, strabismus, cerebral palsy, etc.

In 2000, a group of Korean botulinum toxin experts with world-class expertise joined together to start a business with the common vision of localizing botulinum toxin production. This was the beginning of Medytox.

The Microbial Toxin R&D Center at Medytox, which was established in 2001, specializes in various areas of biotech R&D, including the development of botulinum toxin products. It is now leading the Korean biotech industry by fostering expert researchers and developing advanced technologies.

Based on its advanced technology, Medytox has successfully commercialized botulinum toxin type A formulation, the fourth in the world. Medytox has continually invested in R&D, built advanced biopharmaceuticals-related GMP facilities, and recruited highly talented personnel with experience in clinical trials and international sales.

Medytox strongly believes that these continued efforts and passion to develop biotechnology will help to create more advanced, healthier, and happier lives for everyone.

Who knows botulinum toxin better than Medytox?

R&D

1 World-class R&D capacity and infrastructure for microbial toxin biopharmaceutical products

2 Participation in various government-led R&D projects on botulinum toxin biopharmaceutical products

3 World-class botulinum toxin R&D team

4 Expansion of R&D to cover the development of various medical aesthetics products, including the development of a hyaluronic acid dermal filler

5 Continuous R&D investments for the development of new biopharmaceutical products

Medytox’s biotechnology competitiveness

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Medytox R&D Center

To achieve this, Medytox has made a large-scale investment to establish a R&D center for the development of high quality biopharmaceuticals. Simultaneously, Medytox has recruited top talents in the biopharmaceutical sector to strengthen our foundation, along with the growth numbers.

Through its new R&D center, which is scheduled for completion this year, Medytox hopes to provide innovative and life-changing biopharmaceutical products for consumers everywhere

Moving beyond Korea, Medytox aims to be the No.1 biopharmaceutical company globally.

R&D Center

Biotechnology that changes the future

R&D Center

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Page 16: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Medytox Plant I (Ochang)

Medytox Plant I (Ochang), a botulinum toxin and HA filler manufacturing facility, obtained GMP approval for biologics and injectable from MFDS (Formerly KFDA) in 2004.

This plant was designed as a dedicated facility for manufacture of the botulinum toxin, as well as the final product. HA Filler production facility received ISO13485 (medical device) approval in 2010 and CE mark in 2011.

Medytox Plant I is deeply committed to the manufacturing of highest quality products for consumers everywhere.

Plants

78, Gangni 1-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea

Plants

Plant I Ochang

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Medytox Plant II (Osong)

Plants

Medytox, with global expansion in mind, established the Medytox Plant II (Osong), which is dedicated to toxin production for the pene-tration of the U.S. and the European markets.

Medytox Plant II will play a leading role in producing and supplying  innovative botulinum toxin products intended for the global market.

Currently, the validation to meet cGMP / EU GMP certification requirement has been completed. With the manufacturing capacity at Medytox Plant II, we expect tremendous growth in production and sales.

71, Osongsaengmyeong 6-ro, Mansu-ri, Osong-eup, Heu ngdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea

Plant II Osong

Plants

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Medytox Plant III (Osong)

Plants

Medytox plant III at Osong obtained KGMP approval for toxin facility last December.

Medytox Plant III is a cGMP/ EU GMP compliant facility for production of both botulinum toxin product and HA filler. It will supplement the production quantity to meet the increasing market demand and provide additional capacity to allow for the entry into developed markets such as the US and the EU.

102, Osongsaengmyeong 4-ro, Yeonje-ri, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea

Plant III Osong

Plants

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Page 19: Biotechnology that Changes The Future - Medytox · Medytox is a biopharmaceutical company that changes the future USD 2.6 million 2016 USD 111.9 million 2016 USD 2.2 billion 2017.

Medytox Plant I (Ochang)

78, Gangni 1-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of KoreaT 043 217 1555 F 043 217 1557

Medytox Plant II (Osong)

71, Osongsaengmyeong 6-ro, Mansu-ri, Osong-eup, Heu ngdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea T 043 217 1555 F 043 217 1557

Medytox Plant III (Osong)

102, Osongsaengmyeong 4-ro, Yeonje-ri, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea T 043 217 1555 F 043 217 1557

Medytox Bldg.

Medytox Bldg., 626, Teheran-ro, Gangnam-gu, Seoul, Republic of KoreaT 02 3471 8319 F 02 3476 8372

Medytox Korea Seoul Office

F8, 626, Teheran-ro, Gangnam-gu, Seoul, Republic of KoreaT 080 850 2006 F 02 535 8334

Medytox US Office

20271, Goldenrod Lane, suite 2080/2082, Germantown, MD, 20876 T +1 301 972 0810 F +1 301 972 0682

MDT International (Japan)

6F, HamamatsuchoWest BLDG, 2-10-4, Shibakoen, Minato-ku, Tokyo, Japan T +81 3 6452 9606 F +81 3 6452 9608

Medytox R&D Center (Osong)

71, Osongsaengmyeong 6-ro, Mansu-ri, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of KoreaT 043 217 1555 F 043 217 1557

Medytox R&D Center (Gwanggyo)

1322-8, Iui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea T 070 8666 7796 F 043 217 1557

Contact Information

Global Business [email protected]

Licensing In/Out [email protected]

R&D [email protected]

IR [email protected] / [email protected]

Media Inquiries [email protected]

Human Resource [email protected]

Medytox Korea [email protected]

Medytox US [email protected]

MDT International (Japan) [email protected]

Medybloom China [email protected]

Medytox Taiwan [email protected]

Medytox Hong Kong [email protected]

MedyCeles (Thailand) [email protected]

Contact Information

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