Osong, a K-Bio mecca, signs a contract to move into Miracell

[Hankyung Health] 2019-05-20 “7 Trillion Won if Global New Drug Launches”… K-Bio Strikes Gold in Osong Escape the Crisis! Bio is Hope(1) K-Bio: Kicking Off the Frontier Osong, North Chungcheong Province, is growing into Korea’s largest bio manufacturing base, seven times the size of Pangyo Techno Valley, Gyeonggi Province. As the biomedical device ecosystem develops, more and more pharmaceutical and biotech companies are establishing bases here. According to the Korea Industrial Complex Corporation (KICOX) on the 19th, Osong Bio Valley’s production, which stood at a mere 700 million won in 2009, surged to 1.55 trillion won last year. Production in the first quarter of this year reached 445.6 billion won, and when including the advanced medical complex, which is not included in the statistics, total production is projected to approach 2 trillion won this year. Employment also increased from 14 to 4,058 over the same period. In just ten years since cosmetics company Piontech opened its first factory in Osong Bio Valley in October 2009, Osong has transformed into Korea’s largest bio cluster. Over 200 pharmaceutical and biotech companies have moved into the area. These include pharmaceutical and biotech companies such as LG Chem, Daewoong Pharmaceutical, and Meta Biomed, as well as government agencies such as the Ministry of Food and Drug Safety and the Korea Centers for Disease Control and Prevention, universities such as Chungbuk National University, and hospitals such as Bestian Hospital. Chong Kun Dang Bio and CJ Healthcare are planning to build factories in Osong. This is to foster the high-value-added biohealth industry as a future growth engine. The economic impact of global new drugs is enormous. Humira, a rheumatology treatment developed by AbbVie in the US, generates annual sales of 22 trillion won, comparable to the size of the entire domestic pharmaceutical industry (20 trillion won). Won Hee-mok, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, stated, “Developing a single drug with annual sales of 7 trillion won creates 40,000 jobs.” Osong, a bio-mecca, has become a hub for K-bio. CJ Healthcare and Chong Kun Dang are building new factories one after another. LG Chem’s new diabetes drug Zemiglo, CJ Healthcare’s 30th domestically developed new drug K-Cab, and Medytox’s Medytoxin, Korea’s top-selling botulinum toxin. These products are all produced at the Osong Bio-Science Complex in North Chungcheong Province and exported globally. Since the first company moved in in 2009, Osong Bio Valley has grown into Korea’s largest bio cluster in just 10 years. Production, exports, and jobs have also increased significantly, leading to its recognition as a beacon of hope for K-bio. While Incheon’s Songdo Bio Valley is growing as a bio-valley led by Celltrion and Samsung BioLogics, centered around biosimilars (generic biopharmaceuticals), Osong is establishing itself as a mecca for public-private bio-manufacturing. The domestic pharmaceutical and bio-industry accounts for only 1.7% of the global market, still remaining a marginal player. However, with the increasing number of products entering the global market, centered around Osong Songdo and other bio-valleys, analysts predict a bright future for the domestic bio-health industry. Pharmaceutical and bio companies expanding their Osong plants According to pharmaceutical and bio industry sources on the 19th, CJ Healthcare has established plans to expand its Osong plant, aiming for production in 2021. CJ Healthcare currently operates a 25,663㎡ plant in Osong. K-Cab, a new drug for treating gastroesophageal reflux disease produced there, has been exported to countries such as China, Vietnam, and Mexico. A company representative stated, “With the expansion, we will be able to create an additional 80 to 100 jobs.” Meditox also previously announced plans to invest 47.6 billion won by August next year to build a new plant in Osong to produce botulinum toxin products. Chong Kun Dang Bio plans to invest 45.7 billion won and open its new plant in December 2021. Smaller biotech companies are also establishing bases in Osong. Emgen Plus Miracell and others signed a contract to move into Osong Bio Valley. Ajinomoto Genexine, a Japanese company operating a domestic subsidiary in Songdo, will open a new office in Osong next month. Yaron Silverberg, Chief Scientific Officer at Ajinomoto Genexine, said, “Opening an office in Osong, a city with a concentration of pharmaceutical and cosmetics companies, will allow us to expand our collaborations.” Many companies operating in Osong are leading global markets. Meta Biomed, which operates a plant in Osong, is the world’s leading manufacturer of dental fillings. Its products account for 20% of the global dental fillings market. The creation of a private bio-ecosystem is also in full swing. The Osong Bioscience Complex project began in 1997. Osong’s transformation began in 2010 with the arrival of national institutions like the Ministry of Food and Drug Safety and the Korea Health Industry Development Institute. The 4.63 million square meter first complex, including the advanced medical complex, has been fully sold out. The 3.29 million square meter second complex, which began sales in 2016, has also been fully sold out, excluding the foreign investment zone. This is a year ahead of the original plan. North Chungcheong Province is currently pursuing the development of a third complex, targeting completion by 2026. The land area alone will reach 8.47 million square meters. Once completed, Osong Bio Valley will expand to 16.39 million square meters, a world-class scale. This scalability is driving the increase in biohealth companies seeking to move to Osong. Access to regulatory agencies like the Ministry of Food and Drug Safety and national research facilities like the National Biobank are also considered advantages. As more companies enter the Osong area, a self-sustaining ecosystem is forming. The Innovative New Drug Salon, previously operating in Daejeon and Pangyo, Gyeonggi Province, began meeting in Osong late last year. Bestian Hospital, which opened a 100-bed clinical trial center there last year, spearheaded the initiative. This private networking group brings together researchers in the biotechnology field. The Cosmetics Research Association, a gathering of cosmetics companies, also held its first meeting in March of this year. Osong-based diagnostic device companies, including Sugentech, plan to

Miracell Appoints Dr. Lee Shin-jae, MD, as Research Director

[Daily Medi] 2019-06-04 Miracell Hires Dr. Lee Shin-jae, MD, as Research Director [Daily Medi Reporter Park Dae-jin] Stem cell specialist Miracell (CEO Shin Hyun-soon) recently appointed Dr. Lee Shin-jae, MD, a preventive medicine specialist, as the director of its Stem Cell Research Institute. Dr. Lee, a graduate of Seoul National University College of Medicine, has experience performing stem cell treatments at Cellpia, a stem cell specialty clinic, and is expected to revitalize Miracell’s research and development efforts. Miracell CEO Shin Hyun-soon stated, “With the appointment of Dr. Lee Shin-jae as director, we plan to further accelerate stem cell treatment and research, which are currently attracting attention in various clinical fields.” Director Lee graduated from Seoul National University College of Medicine, completed a residency in preventive medicine, and earned a master’s degree from Seoul National University Graduate School of Public Health. He has served in various roles, including as a member of the Medical Information Committee of the Korean Medical Association, as the director of the Chuncheon Mental Health Center at the Seoul National University Graduate School of Public Health, as an epidemiologist for the Ministry of Health and Welfare, and as an evaluation committee member for the Regional Health and Medical Plan. djpark@dailymedi.com

Miracell, an autologous bone marrow stem cell treatment for cartilage defects, is gaining attention.

Hyalopaste… Aids bone marrow stem cell treatment for cartilage tissue regeneration and prevents bone marrow loss. Invossa injection, previously used to treat knee osteoarthritis, was suspended from sales and manufacturing by the Ministry of Food and Drug Safety on March 31, 2019, sending shockwaves through the industry. This suspension stemmed from safety concerns stemming from differences between the cells submitted by Kolon Bioengineering at the time of approval and the cells actually used in the treatment. Amidst this situation, Miracell, the only company to have achieved a new medical technology using autologous bone marrow stem cell therapy for patients with cartilage defects, has been attracting attention for being the first in Korea to obtain import approval for its bone scaffold, a biomaterial graft used in conjunction with bone marrow stem cells, and for its safest treatment approach. Miracell’s “HYALOFAST” has been approved by the Ministry of Food and Drug Safety (Approval No. 12-1205) pursuant to Article 15 of the Medical Devices Act and Article 18, Paragraph 3 of the Enforcement Decree of the same Act. It is an absorbable support material that aids in the establishment of bone marrow stem cells and prevents bone marrow loss during bone marrow stem cell treatment for cartilage tissue regeneration. Unlike conventional film-based scaffolds, Hyalofast utilizes a 3D porous fibrous tissue. Bone marrow stem cells nestle in the interstitial spaces between the fibers, interacting with mesenchymal stem cells without the need for additional fixation. This promotes adhesion and viability, and enables cell differentiation to regenerate osteochondral defects. The surgery involves making a minimal incision in the patient’s knee, identifying the cartilage defect, and inserting the stem cell therapy. Compared to artificial joint surgery, the surgery takes less time and regenerates the patient’s own cartilage, reducing the risk of side effects. Recovery is also rapid, with patients able to return to the hospital after 3-5 days of postoperative rehabilitation. After discharge, patients undergo rest and rehabilitation for three months, with normal activities resumed after six months. Almost all patients with severe knee arthritis with worn cartilage fail to regenerate with normal articular cartilage with conventional treatments, resulting in unsatisfactory short- and long-term outcomes. However, patients receiving stem cell therapy are highly satisfied with the treatment, and the popularity of stem cell therapy is increasing due to its efficacy and safety. Furthermore, stem cell therapy is widely used beyond the knee joint, including the ankle, and its use is expected to expand to other joints, such as the shoulder, providing promising news for patients suffering from related conditions.

Miracell Develops Stem Cell Isolation System

[nbn Domestic and Foreign News] January 25, 2019 Miracell, a stem cell company, announced on the 25th that it has developed a stem cell isolation system that rivals world-class technology. This system, which is capable of isolating and concentrating stem cells and immune cells from bone marrow and blood, received approval from the Ministry of Food and Drug Safety in the latter half of last year and is currently being sold to hospitals and clinics.Miracell’s recently launched bone marrow-derived stem cell and immune cell isolation/concentration system, currently available worldwide, holds significant global significance, with only three or four systems currently on the market. This development is expected to further narrow the accessibility of demanding procedures using bone marrow-derived cells. With the growing importance of cell-focused systems, which have traditionally relied on blood-derived cell isolation/concentration systems or platelet-rich plasma (PRP),we anticipate increased utilization in hospitals and clinics both domestically and internationally. The currently available stem cell and immune cell separation/concentration system can be used to treat conditions previously designated as new medical technologies by Miracell Co., Ltd., such as cartilage defects, critical limb ischemia, acute myocardial infarction, and dissecting osteoarthritis of the knee joint. It can also be used as a limited medical technology for conditions such as diabetic critical limb ischemia and nonunion/delayed union. Miracell Co., Ltd. has excellent technological prowess with 6 registered technology patents and 8 patent applications, and currently has patents registered for a decanting kit that facilitates component-specific separation and extraction (2018.06.28), a centrifugal container that facilitates component-specific separation and extraction (2018.09.06, 2018.10.18), a swing rotor assembly for centrifugal separators (2018.08.23), a centrifugal container (2018.08.29), and a dual-wavelength skin treatment laser device (2010.07.21). In addition, a centrifugal container that facilitates component-specific separation and extraction (2017.07.17), a centrifugal kit that facilitates sample collection and component-specific separation (2017.07.17), a bucket for centrifugal separators (2018.07.20), and a component separation device for centrifugal separators. Patent applications include a floater (January 9, 2018), a centrifuge container (March 30, 2018), a vending machine for personalized cosmetics manufacturing using AI (May 8, 2018), and a centrifuge equipped with a charging device (July 20, 2018). As stem cells continue to receive attention in the field of regenerative medicine, the development of medical equipment that efficiently separates and concentrates stem cells is of great global significance.This technological development is expected to brighten Miracell’s prospects for future expansion into overseas markets. Jang Ik-kyung jik7522@nbnnews.co.kr

Stem Cell Company Miracell Issues Correction Regarding False Claims About Salary Standards

[Medical Newspaper] July 23, 2018 /In the June 11th and 12th articles titled “Where Does the ‘Moral Hazard’ of Stem Cell Companies End?” and the June 18th article titled “Serious ‘Moral Hazard’ in Stem Cell Companies,” Miracell applied for a new medical technology assessment for “autologous bone marrow stem cell therapy for patients with cartilage defects.” However, the technology was determined to be research-level technology with unproven safety and efficacy. Therefore, it cannot be commercially used in clinical settings. Furthermore, despite the fact that the reimbursement standards remained unchanged, Miracell spread false information claiming that “the age restriction for stem cell therapy for cartilage defects had been lifted,” and raised concerns about “moral hazard.” But Miracell’s ‘Autologous bone marrow stem cell therapy for patients with cartilage defects’ was given a limited medical technology grade B in the new medical technology assessment. On May 29, 2018, it was confirmed that Miracell Co., Ltd. had been added to the list of technologies eligible for limited medical technology applications with confirmed safety. Therefore, it has been confirmed that Miracell Co., Ltd. did not spread false information, and we are correcting this. This report is subject to the mediation of the Press Arbitration Commission. Medical Newspaper medicalnews@bosa.co.kr

Miracell Obtains Medical Device Manufacturing and Sales Approval from the Ministry of Food and Drug Safety

[Medworld News] October 18, 2018 Miracell (CEO Shin Hyun-soon), a stem cell company that promotes “the world’s safest stem cell technology,” has received approval from the Ministry of Food and Drug Safety to manufacture and sell medical devices. CEO Shin Hyun-soon announced this in a recent letter to shareholders, “Miracell’s technology competes with the world’s best, with five registered technology patents and nine patent applications. We are currently conducting a cell count to obtain an equivalence assessment to verify the excellence of our medical devices.” Miracell holds five technology patents: a decanting kit for easy component separation and extraction, a centrifuge vessel for easy component separation and extraction, a swing rotor assembly for centrifuges, a centrifuge vessel, and a dual-wavelength laser device for skin treatment. Miracell holds eight domestic patents and has one international PCT patent pending, including: a centrifuge vessel for easy component separation and extraction; a centrifuge kit for easy sample collection and component separation; a bucket for centrifuges; a component separation plotter for centrifuges; a vending machine for customized cosmetics manufacturing using AI; and a centrifuge equipped with a charging device. Currently, Miracell’s stem cell therapy for diabetic lower extremity ischemia and knee arthritis has been designated as a limited new medical technology and has been selected for new support under the Health and Medical Technology Research and Development Project. Professor Chae Dong-sik (Orthopedic Surgery) at Catholic Kwandong University International St. Mary’s Hospital has demonstrated a cartilage regeneration rate of over 70% using autologous bone marrow stem cell transplantation using Miracell’s SmartPRep2 BMAC system, a new medical technology. Professor Eun-soo Park (Department of Plastic Surgery) at Soonchunhyang University Bucheon Hospital is also giving hope to patients who had previously undergone limb amputation through autologous bone marrow stem cell therapy for diabetic lower extremity ischemia using Miracell’s Smart Prep 2 Bio-Mechanical System. Reporter Myeong-in Park pmi0901@hanmail.net

Miracell: “We will dedicate ourselves to global research and development.”

[Medical Newspaper] October 18, 2018 Shin Hyun-soon, CEO, revealed in a shareholder letter that he has “5 technology patents and 9 patent applications, on par with the world’s best.” Stem cell specialist Miracell (CEO Shin Hyun-soon) announced in a shareholder letter on the 18th that it will dedicate itself to continuous research and development toward becoming the world’s leading stem cell specialist. Miracell collaborates with domestic and international medical institutions on research and development to specialize in safe stem cell treatments. Miracell aims to lead the way in advanced medical technology, not only treating diseases but also emphasizing ethics and morality. Its goal is to contribute to the development of hospitals and the promotion of public health. CEO Shin Hyun-soon stated, “We are pleased to announce that the Ministry of Food and Drug Safety has approved the manufacture and sale of medical devices, a long-awaited project that has been in the works for a long time. With five registered technology patents and nine pending patents, our technology stands shoulder to shoulder with the world’s best.” He added, “We are currently conducting a cell count to verify the excellence of our medical devices. We will continue to strive to expand beyond the domestic market and into global export markets, thereby increasing sales and achieving further growth for Miracell.” Miracell currently holds five technology patents, including a decanting kit for easy ingredient-specific extraction, a centrifuge vessel for easy ingredient-specific extraction, a swing rotor assembly for centrifuges, a centrifuge vessel, and a dual-wavelength laser device for skin treatment. Furthermore, Miracell holds eight domestic patents and one international PCT patent application, including a centrifuge vessel for easy ingredient-specific extraction, a centrifuge kit for easy sample collection and ingredient separation, a bucket for centrifuges, a component separation plotter for centrifuges, a vending machine for personalized cosmetics manufacturing using AI, and a centrifuge equipped with a charging device. Meanwhile, Miracell’s stem cell therapy for diabetic lower extremity ischemia and stem cell therapy for knee arthritis were selected as limited new medical technologies and eligible for new support from the Health and Medical Technology Research and Development Project. Professor Chae Dong-sik (Orthopedic Surgery) at International St. Mary’s Hospital has demonstrated a cartilage regeneration rate of over 70% using autologous bone marrow stem cell transplantation using Miracell’s new medical technology, the “Smart Prep 2 Bi-Mac System.” Professor Park Eun-soo (Plastic Surgery) at Soonchunhyang University Bucheon Hospital is also providing hope to patients who previously had to undergo limb amputation through autologous bone marrow stem cell therapy for diabetic lower extremity ischemia. Reporter Oh In-gyu 529@bosa.co.kr

Chungbuk Biotech Promotion Center Leads KRW 240.2 Billion in Corporate Investment

[Chungcheong Ilbo] December 11, 2018 The Bio-industry Investment Promotion Team (PNP), directly under the Chungcheongbuk-do Bio-industry Bureau, signed investment agreements with 22 companies and attracted KRW 240.2 billion in investment in just six months since its launch. This represents 85% of the provincial Bio-industry Bureau’s total investment attraction performance for the year. According to North Chungcheong Province on the 11th, the PNP was established on June 4th to attract outstanding domestic bio companies, accelerate the establishment of Osong Bio Valley’s R&D capabilities, and serve as a foundation for the domestic and provincial bio-industry engine. Since then, the PNP has initiated investment attraction activities in Osong Bio Valley and has conducted comprehensive attraction and promotional activities for approximately 50 bio-related companies and public institutions. Furthermore, the PNP has also worked to revitalize the province’s bio-industry by improving various systems and developing policies. A prime example is the recognition that the Osong Advanced Medical Complex was excluded from the youth transportation subsidy program for small and medium-sized enterprises in industrial complexes. They persuaded relevant ministries and agencies to extend the benefits to 88 companies and approximately 200 employees. The attraction team also took the lead in improving the working environment and living conditions for workers in the Osong complex, including securing land for the “SME Joint Workplace Daycare Center” managed by the Korea Workers’ Compensation and Welfare Service. In particular, they focused on attracting promising biotech companies and institutions. With the global aging population, leading pharmaceutical companies are investing astronomical sums, yet tangible results remain elusive. The attraction of G2G Bio, which is developing an improved dementia treatment, to Osong is considered a model case. Miracell, which researches stem cell therapy, a cutting-edge biopharmaceutical, is expected to create approximately 120 employees and is expected to contribute to establishing Osong as a forward base for the development of cutting-edge biopharmaceuticals. Osong-based Osbio is a foreign-invested company established with overseas investment (from Japan). The company is expected to create high added value in the agricultural industry through research on natural products produced in agricultural production research complexes and smart farms (farms operated using information and communication technology). It is also expected to contribute to the development of the province’s agricultural and biotechnology industries by expanding into overseas markets. The attraction team plans to continue its active recruitment efforts next year, identifying biotechnology companies suitable for North Chungcheong Province and conducting on-site consultations, with the goal of attracting 3 trillion won during the 7th elected government. Kwon Seok-gyu, Director of the Provincial Biotechnology Industry Bureau, acknowledged, “The achievements in attracting investment from biotechnology companies and institutions in just six months since the formation of the attraction team are the fruit of the team’s tireless efforts.” He expressed his commitment, saying, “We will expand the biotechnology industry to all cities and counties in the province and further solidify North Chungcheong Province’s status as a biotechnology hub that will lead the biotechnology economy.” Reporter Kim Hong-min | hmkim2075@daum.net

Miracell Accelerates Development of Stem Cell Anticancer Therapy

[Edaily] February 1, 2018 Miracell in final stages of anticancer efficacy testing Miracell, a stem cell specialist, has recently begun anticancer efficacy testing using blood-derived immune cells and stem cells, bringing the development of a treatment closer to reality. Miracell is currently using its proprietary cell separation and concentration technology to rapidly isolate immune cells and stem cells from blood, and is conducting analysis of their anticancer effects on colon cancer cells. A Miracell representative stated on the 1st, “This anticancer cell therapy candidate is demonstrating exceptional anticancer efficacy.” They added, “In particular, the treatment preparation period is much shorter than existing products, so we anticipate more efficient application in the future.” Miracell, a company approved for cartilage regeneration, lower extremity ischemia, and myocardial infarction,is currently developing a minimally invasive source technology that can be easily processed in-hospital, targeting general hospitals, semi-general hospitals, and clinics. This technology has already signed contracts with several Southeast Asian countries and is preparing for export. Miracell is also developing stem cell culture cosmetics, which are receiving rave reviews.Miracell’s stock is currently traded on the over-the-counter market. Shin Hyun-soon, Co-CEO of Miracell, stated, “We are confident that the cell therapy products we are developing will establish themselves as a new growth engine through overseas exports.”Cell therapy products are pharmaceuticals used for therapeutic, diagnostic, and preventive purposes. They involve a series of procedures, such as ex vivo proliferation, selection, or other modification of the biological properties of living autologous, allogenic, or xenogenic cells, to restore cell and tissue function.Cell therapy products can be categorized into somatic cell therapy and stem cell therapy, depending on the type and level of differentiation of the cells used.Stem cell therapy products are further categorized into embryonic stem cell therapy and adult stem cell therapy. Medical institutions are permitted to process autologous or allogeneic cells during surgery or other procedures, provided that minimal manipulation (such as simple separation, washing, freezing, or thawing, as long as biological properties are maintained) is performed without safety concerns.(Article 2, Paragraph 14 of the Regulations on Approval and Review of Biochemical Products, etc.)Furthermore, among cell therapy products deemed safe, processing within medical institutions is considered minimal manipulation. Miracell, which has received approval to do so, has created a stir in the medical community. Lee Soon-yong, Edaily