Since February 24, 2016, Japan's JCR pharmaceutical companies began selling allogeneic mesenchymal stem cell products Temcell. The product is used for hematopoietic stem cell transplantation after one of the severe complications "acute shift reaction (GVHD)" treatment, won the approval of the Ministry of health, labor and welfare of Japan in September 2015.
Temcell pricing for 1 bags of 860 thousand yen (about 50 thousand yuan), a course of treatment for 2 bags per week, a total of 4 weeks 8 bags. By 2020, the product will be available in 260 patients in Japan for treatment, its sales forecast of about 3 billion 500 million yen.
This makes the cell therapy industry for the boiling Temcell in the end is what is sacred? Let's look back on the development process of the product.
1 Temcell before also known as Prochymal, for the United States Osiris company developed the first. 2012 Prochymal successively in Canada and New Zealand for production of documents, but due to financial reasons has not formally put into production and sales. In October 2013, Osiris company will be the transfer of ownership of the product with the Australian Mesoblast company, and in September 2014 from JCR Corporation of Japan in Temcell product to the Japanese Ministry of health, labor and welfare proposed new drug application and September 2015 to obtain production approval.
2 stem cell related laws and regulations of the introduction: in 2013, Japan introduced a standardized management of the cell products, will be classified as a new classification of cell products: regenerative medicine and other products. The measures for the administration of the provisions: for the heterogeneity of regenerative medicine products, if we can determine its safety and to estimate its validity, you can through the additional conditions and duration, especially in early May to be admitted. Then, re verify its security and effectiveness. The change in this policy has made the management of personalized medicine once again a big step forward.
3 Temcell for fully approved drugs. Temcell's review noted that the approval of the species and without additional conditions and time limits (meaning fully approved. The early approval, which corresponds to the full approval, is also known as a semi approval.
There are very few cell types, including stem cell and other cell types, which are approved worldwide, and the number of products in which allogeneic stem cell products. So what are the
important meanings of Temcell in Japan and the listing?
1 the feasibility of mass production of cell products: the majority of the global cell therapy has been the main source of autologous cell therapy, and then this personalized medical treatment will inevitably make it expensive. Stem cells from allogeneic stem cell therapy is expected to achieve mass production, continuous optimization of the production process is bound to reduce the cost of treatment, so as to reduce the medical burden. However, another voice is from the point of view of the effect of the "mess" produced cell products is better than customization "stem cells" questioned more issues that we need to continue to study to answer one by one.
2 to promote the development of China's cell industry: since the 2012 stem cell industry has been a big shock, China's stem cell policies are constantly updated and improved. Including the CFDA and August 2015 Planning Commission jointly issued by the stem cells in clinical research management approach (Trial) "and" stem cell preparation quality control and clinical before research guidelines (Trial) ", and December 2015 Planning Commission issued the" about developing stem cells in clinical research machine structure of filing work notice "showed that the stem cells management more standardization, standardization. However, these are from the real approval of China's first stem cell products, there is still a way to go. The Temcell's approval will provide us with a reference and reference.
3. The angels and Demons coexist: even though the mesenchymal stem cell immunogenicity is relatively low and based on immunosuppressive characteristics for GVHD treatment. However, excessive immune suppression of GVHD is reduced at the same time, there are white blood cell, platelet reduce, infection, sepsis, renal injury, and promote tumor growth and other side effects, so must to in the implementation of the emergency medical facility for treatment. Therefore, how to control the "double edge" will be the next problem. And the recent purple tumor immune treatment of gene regulation technology of new technology car-t "in the cell mounted switch" may be possible to solve the difficult problem.
Although stem cell treatment of the industrialization of the road is full of ups and downs, but we believe that the stem cell industry in the spring is coming, let us wait and see.