BioTime, Inc will organize a new subsidiary, BioTime Asia, Limited, for the purpose of clinically developing and marketing therapeutic stem cell products in the People's Republic of China, and marketing stem cell research products in China and other countries in Asia. BioTime Asia will initially seek to develop the therapeutic products for the treatment of ophthalmologic, skin, musculo-skeletal system and haematologic diseases, including the targeting of genetically modified stem cells to tumours as a novel means of treating currently incurable forms of cancer.
BioTime has engaged the services of Dr Lu Daopei to facilitate BioTime Asia in arranging and managing clinical trials of therapeutic stem cell products. Dr Lu is a world-renowned haematologist and expert in the field of haematopoietic stem cell transplants who pioneered the first successful syngeneic bone marrow stem cell transplant in the People's Republic of China to treat aplastic anaemia and the first allogeneic peripheral blood stem cell transplant to treat acute leukaemia. Nanshan Memorial Medical Institute Limited (NSMMI), a private Hong Kong company, has entered into an agreement with BioTime under which NSMMI will become a minority shareholder in BioTime Asia and will provide BioTime Asia with its initial laboratory facilities and an agreed number of research personnel and will arrange financing for clinical trials.
BioTime and its subsidiary Embryome Sciences, Inc will license the new venture rights to use certain stem cell technology, 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 for use outside of China any new technology that BioTime Asia might develop or acquire.
BioTime's obligations are subject to certain conditions and contingencies, including the completion of feasibility studies for the venture. Either BioTime or NSMMI may terminate the agreement if certain clinical trial milestones are not met, including the commencement 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 any clinical trials can commence, BioTime Asia would have to compile sufficient laboratory test data substantiating the characteristics and purity of the stem cells, likely to include animal studies, and then obtain all necessary regulatory and clinical trial site approvals, and assemble a team of physicians and statisticians for the trials.
"Dr Lu is widely recognized for his pioneering research in stem cell biology and for instituting leading stem cell-based therapies through Daopei Hospital in China," said Michael West, BioTime's CEO. "We look forward to working together to potentially bring to the population of China new life-saving therapies based on stem cell technology."
"I have dedicated my life to treating patients who suffered from dreadful hematologic ailments, and I wish I can continue to make breakthroughs and contributions to China's stem cell therapy," said Dr Lu.
Professor Lu Daopei, served as director of Peking University Institute of Haematology from 1981-2005. Dr Lu was elected as a permanent member (academician) of Chinese Academy of Engineering, was elected as a member of the second presidium of CAE.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders.
Nanshan Memorial Medical Institute is a multi-platform organization engaging in healthcare-related R&D, education, and innovative therapeutics.