基亞反向併購 進軍澳洲股市 2015年05月04日 04:10 記者杜蕙蓉／台北報導 基亞檢驗試劑布局再創新利機！該公司上月30日公告旗下TBG（開曼）反併購澳洲上市公司Progen，此舉將讓基亞拿下Progen 71.73％的主導權，打進澳洲資本市場，開啟國內生技業首家在海外掛牌先例。不僅如此，基亞也正力邀國內重磅級科技大廠入股，參與Progen公司將在近期辦理800～1,000萬澳元（約2.4億台幣）的現金增資，雙方在聯盟和技術資源的整合，也讓TBG從原本只生產檢驗試劑產品拓展至檢驗設備儀器的產出。基亞副總經理歐朝銓表示，Progen和TBG合併後，Progen將更名為TBG，此一轉投資公司資源的整合，有利於TBG檢驗試驗業務的上市及籌資。就公告內容，基亞是以百分之百持股的TBG（開曼），與持股19.7％的Progen，以1:1的換股模式進行股份轉換，此一反併購案，讓基亞取得Progen71.73％過半股權，Progen的營運也將由原本的新藥研發、生產延伸至檢驗試劑領域，而TBG（開曼）旗下包括台灣TBG、廈門TBG（德必碁）和美國TBG，也將納入Progen的事業版圖。由於Progen也將更名為TBG，未來在澳洲上市公司中，TBG的營運類別主力將以檢驗試劑為主。在檢驗試劑開發已有戰果的基亞，2012年11月才將轉投資上海浩源以6,800萬美元（約台幣20億元）出售給國際大廠PerkinElmer（珀金埃爾默公司、簡稱PKI），此次反併購案，讓基亞旗下TBG順勢進軍澳洲資本市場，更備受關注。歐朝銓表示，TBG在澳洲上市將有助於檢驗試劑產品在市場上的品牌形象。由於中國已成為全球最重要醫療消費市場，TBG已在廈門海滄區建置的德必碁（廈門）檢驗試廠已正式營運，今年將進行試產及產品報批，預期TBG在大陸已有的營運據點和生產基地，將特別受到澳洲市場的青睞。法人表示，澳洲生技產業發展蓬勃，在生物製劑、醫藥、及醫材等領域都有全球頂尖的基礎研究成果，TBG在澳洲上市將有助於未來應用當地先進技術結合台灣製造能力的優勢，在市場上攻城掠地。
Texas BioGene Inc. (TBG) is a global molecular diagnostics company dedicated to the development, manufacture and marketing of nucleic acid testing kits and services. Founded in Texas, USA (1999), TBG is one of the leading providers of quality HLA Typing Kits for immune matching of bone marrow, cord blood and solid organ transplants. TBG has instituted a comprehensive quality control system and is an ISO13485 accredited manufacturer of medical devices including CE approved typing kits. Currently TBG has R&D, manufacturing and sales operations in the US, Taiwan and China. Due to its unparalleled performance in immune matching ability, nucleic acid testing is becoming an essential tool in helping the clinician with critical transplant decisions. TBG is continually pushing to the forefront of nucleic acid testing for diagnostics. From the extraction of nucleic acids, amplification and detection of infectious diseases, genotyping and viral load testing, TBG is commited to expanding the applications of our core technology. To this end TBG's EZbead Systems for automated nucleic acid extraction based on magnetic bead technology have been introduced to help make nucleic acid diagnostics accessible to laboratories worldwide.
Medigen Biotechnology Corporation now ASHI laboratory accredited for HLA typing Post Date: 2009-01-01 ASHI accreditation a first for Taiwan based HLA typing laboratory Medigen Biotechnology Corporation, the parent company of Texas Biogene Inc., has received laboratory accreditation by the American Society of Histocompatibility and Immunogenetics (ASHI) for the time period from 01/01/2009 to 12/31/2010. With over 200 ASHI accredited laboratories worldwide, Medigen is the only ASHI accredited laboratory with both low and high resolution HLA typing service in Taiwan. Our aim is to promote quality practice in Histocompatibility and Immunogenetics through compliance with ASHI standards and to integrate the valuable resources in organ transplantation and blood banking in Taiwan into the international arena. The accreditation process included a rigorous evaluation of laboratory personnel, procedures and facilities to determine if they are in compliance with published standards of ASHI. Under the guidance of an accredited US based laboratory director Medigen is now offering exceptional low and high resolution HLA typing service by maintaining the highest standards of reliability and quality in histocompatibility testing laboratories. Medigen's strategy for developing Nuclear Acid Testing (NAT) products is via global merger and acquisition (M&A). In 2004, Medigen acquiredTexas BioGene Inc.(TBG), a United States company that develops NAT for organ and bone marrow transplantation and Shanghai Haoyuan Biotech Co., Ltd., in 2007. Haoyuan is a provider of nucleic acid-based blood screening solutions for the blood banking and clinical diagnostics to market in China. As a global molecular diagnostics company, Medigen vertically integrated its ability to design, develop, and manufacture in order to acquire international IVD certifications. As a result, Texas BioGene NAT products are certified by the Taiwan Department of Health, 510(k) approved by the US FDA and CE-IVD marked by the European Union. Based on these approvals, product distribution now covers over 20 countries including United States, Germany, France, Italy, India, Malaysia, Singapore, China and Taiwan. Furthermore, strategic alliance was formed with Perkin Elmer in Nov. 2012 through the sale of Shanghai Haoyuan Biotech equity stakes for $38.0 million in cash. As the waitlist of transplant recipients continues to grow worldwide, TBG recently developed an ultra-high resolution DNA sequencing reagent to prolong the lifespan of each precious transplant. By using a full coverage "Group Specific Amplification" (GSA) DNA sequencing design, we can now investigate regions of our DNA that can be used to reduce the rate of transplant rejection. To take advantage of Taiwan's strength in electronics, TBG developed one of the first "SMART" Automation System for transplant IVD products. Not only will this automation system reduce human errors, the patent pending "SMART Processing" control software can provide the most efficient method to reach an ultra-high DNA typing resolution. TBG (Xiamen) Corp. was established in January 2014 with location in China's Xiamen Haicang Bio Bay. It has a 6500 square meter plant with state of the art facility capable of large scale manufacturing dedicating to the development, manufacture and marketing of IVD related nucleic acid testing kits and services. Building on its core technologies, TBG has been pushing to the forefront of nucleic acid testing for diagnostics in pathogens, personalized medicine and genetic diseases, as well as providing third-party testing services.
Latest business update on Medigen Biotech Corp. 08/21/2014 News Medigen's ongoing business portfolio includes the following:
A .PI-88: PI-88, a new compound to be used in early stage of liver cancer to prevent recurrence after surgical resection. PI-88 is currently in Phase III clinical trial.
B: OBP-301 OBP-301, a new compound to be used in mid to late stage liver cancer. Co-developed by Medigen and Japan's Oncolys BioPharma Inc., OBP-301 has obtained the permission from Taiwan's TFDA and Korea's MFDA to conduct phase I/II clinical trial in National Taiwan University Medical Hospital and Pusan National University Medical Hospital simultaneously.
C: Preclinical new drug development 1.Monoclonal Antibody (mAb) The R&D team of Medigen is targeting on therapeutic applications in infectious diseases such as flu virus, RSR, HBV, HCMV and multi-drug resistance S. aureus as well as autoimmune diseases such as RA, IBD, SLE and psoriasis using Human native mAbs. 2. Virus-like particles Vaccine Medigen has applied for provisional patent to USPTO on technology related to virus-like particles on Aug. 7th, 2014.
D: Molecular Diagnostics 1.Medigen invested USD $3 million through TBG Inc. in January 2014 for the establishment of TBG (Xiamen) Corp. dedicating to the development, manufacture, and marketing of nucleic acid testing kits. The plant located in Haicang Bio Bay, Xiamen is currently under construction. 2.Medigen has signed a two year contract with Hualien Tzu Chi Hospital to provide HLA-typing kits to Buddhist Tzu Chi Stem Cells Center (BTCSCC).
E: Medigen Vaccinology Medigen Vaccinology Corp. has signed a licensing agreement with NHRI for the development and commercial rights of H5N1, H7N9 and EV71 vaccines. The vaccine plant located in Chupei is currently under construction and expects to complete by 2015.
F: Winston Medical Supply Co. 1.Medigen Biotechnology Corp. acquired 68% equity stake of Winston Medical Supply Co. in January 2014. Winston's main businesses include ophthalmic products and hormones drugs. 2.Winston's new manufacturing plant is currently in the reviewing process for PIC/S GMP certification.
Source: http://www.medigen.com.tw (MAY, 2015)
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