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» 23/07/2009 [Company watch]
China Aoxing Pharmaceutical Corp. Receives Renewal of GMP Certification for Capsule Dosage Form of Pharmaceutical Products
» 15/03/2010 [Industry news]
Recordati S.p.A And Lee Pharmaceutical Announce Partnership For Zanidip(R) In China
» 26/10/2009 [Finance]
China Growth to Remain Fast in Fourth Quarter, Official Says
» 17/08/2009 [Industry news]
Chindex Posts Profit on Product Sales, Health Services
» 07/05/2010 [Industry news]
Hong Kong: Recall of all products manufactured by Quality Pharmaceutical Lab Ltd
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»24/09/2009 [Industry news]
BioTime Faces Daunting Conditions to Set Up China Stem Cell Subsidiary

BioTime, Inc. will establish a China subsidiary, called BioTime Asia, to market the company’s stem cell products in China and throughout Asia. The company will also use its technology to develop stem cell therapies aimed at treating a number of diseases, including the use of genetically modified stem cells to treat currently incurable forms of cancer. BioTime has engaged the services of Dr. Lu Daopei, a prominent China heamatologist, to help set up and manage the clinical trials of its therapeutic stem cell products.

 
BioTime, Inc. will establish a China subsidiary, called BioTime Asia, to market the company’s stem cell products in China and throughout Asia. The company will also use its technology to develop stem cell therapies aimed at treating a number of diseases, including the use of genetically modified stem cells to treat currently incurable forms of cancer. BioTime has engaged the services of Dr. Lu Daopei, a prominent China heamatologist, to help set up and manage the clinical trials of its therapeutic stem cell products. Dr. Lu, who was the Director of Peking University Institute of Hematology from 1981-2005, is an expert in the field of heamatopoietic stem cell transplants. He pioneered the first successful syngeneic bone marrow stem cell transplant in the PRC to treat aplastic anemia and the first allogeneic peripheral blood stem cell transplant to treat acute leiukemia. Nanshan Memorial Medical Institute Limited (NSMMI), a private Hong Kong company, will become a minority shareholder in BioTime Asia. It will provide BioTime Asia with its initial laboratory facilities and research personnel and will arrange financing for clinical trials. The agreement is subject to some daunting conditions. BioTime must complete feasibility studies for the venture. Either BioTime or NSMMI may terminate the agreement if specified clinical trial milestones are not met, including the beginning of the first clinical trial of a therapeutic stem cell product within two years. BioTime’s potential therapeutic products are at a very early stage of preclinical development. Before starting clinical trials, BioTime Asia will have to compile laboratory test data substantiating the characteristics and purity of the stem cells, including animal studies. Then it must obtain all necessary regulatory and clinical trial site approvals, and it must assemble a team of physicians and statisticians for the trials. BioTime and its US subsidiary Embryome Sciences, will license the rights to use certain stem cell technology to BioTime Asia, and will sell the new venture stem cell products for therapeutic use and for resale as research products. To the extent permitted by law, BioTime Asia will license back to BioTime any new technology that BioTime Asia might develop or acquire for use outside of China. In the US, BioTime has two product lines: a line of blood plasma volume extenders, which are marketed by Hospira (NYSE: HSP) in the US, and a human embryonic stem (hES) cell and induced pluripotent stem (iPS) cell technology. In May 2008, BioTime, through its Embryome Sciences subsidiary, bought an exclusive license for the ACTCellerate technology and approximately 100 progenitor cell types made using ACTCellerate technology.

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