Release date: 2017-08-24
Foreword
With the increasing aging trend in the world, the incidence of degenerative diseases is increasing, which has led to the development of regenerative medicine with stem cell technology as the core. Cellular drugs are considered to be the third generation of drugs after chemical drugs and antibody drugs. At present, there are dozens of cell treatment products approved worldwide, of which less than ten kinds of stem cell drugs are strictly speaking (some cell products belong to somatic cells, such as chondrocytes and epidermal cells).
Globally approved marketed stem cell drugs
Up to now, a total of 8 stem cell drugs have been approved worldwide, of which South Korea has 4 seats. In addition, Prochymal, which was approved in Canada and New Zealand in 2012, and Temcell, which was launched in Japan in 2016, are based on the same technology and are licensed by Osiris to JCR-related technologies. Currently, Osiris' Prochymal project has been sold to Mesoblast. It is worth mentioning that Prochymal's Phase III clinical practice in the United States did not meet its expectations, which made it impossible to market in the United States. The same technology can be approved by Canada, New Zealand, and Japan, reflecting the differences in access thresholds for stem cell drugs in different countries.
Currently, the globally approved stem cell drugs are approved for approval, and are generally approved after completion of Phase II clinical trials. This type of approval is generally limited approval, and will be re-approved after about 5 years to determine whether it can continue to sell. Some time ago, the world's first approved stem cell drug Hearticellgram-AMI faced such a test, and public opinion was not optimistic. The official approval results have not been announced.
The world's first stem cell treatment drug Hearticellgram-AMI
Regardless of the approval method and efficacy, even for the stem cell drugs already on the market, most of the market prospects are not bright. In addition to the Prochymal series, only the other five stem cell drugs, Cartistem, are cells of allogeneic origin, and the market performance is also the best. Autologous cell preparation means long production cycles, difficult to homogenize quality standards and high costs, which are fatal flaws for a successful product. Anterogen is currently developing a variant of Cuepistem for this reason.
Globally marketed stem cell drugs
The reason why Chinese stem cell drugs are difficult to break through
For an emerging field like regenerative medicine, China is not too late to start. Compared with other fields, the gap with the international advanced level is small, and some directions are even in the forefront of the world. Judging from the number of published papers by Pubmed, in the past 5 years (pushing from August 16, 2017), there are 61,819 articles on stem cell research, including 13,193 in the United States and 12,644 in China. Slightly lower, accounting for more than 20%.
Over the past decade or so (especially in the years before 2015), China's regulation of stem cell clinical applications has been in a multi-faceted situation. The SFDA and the Health Planning Commission each issued relevant regulations, and the industry's response did not unexpectedly choose the easy path.
As early as May 26, 1999, the SFDA issued the "New Biological Products Approval Measures", and officially adopted the "Measures for the Administration of Drug Registration" (Trial) (Decree No. 35) promulgated on October 30, 2002. Somatic cells are listed as three new drugs for biological products. This provision has been in use in the previous revisions of the Drug Registration Management Measures. Therefore, the attitude of the SFDA on the stem cell marketing pathway has not changed, that is, according to the new category of biopharmaceuticals.
According to the search results of the official website of the SFDA Drug Evaluation Center, 11 stem cell drug declarations have been accepted so far (excluding the declaration and withdrawal), mainly umbilical cord and bone marrow-derived mesenchymal stem cell injections, indications include liver fibrosis, heart Terrier and so on. The earliest declaration can be traced back to the "bone marrow primitive mesenchymal cells" declared by the Institute of Basic Medical Sciences of the Chinese Academy of Medical Sciences on October 10, 2004. In addition, according to the results of the SFDA Drug Approval Center drug clinical trial registration and information disclosure platform, three drug clinical trials (CTR20132003, CTR20132698, CTR2013202) were carried out on bone marrow primordial mesenchymal cells, including indications for graft-versus-host disease and acute The heart attack, the last one was also completed in 2011. However, none of the above 11 stem cell drug declarations have entered the approval process, and people can't help but wonder what happened in the next decade or so.
SFDA stem cell drug declaration
In the case of the Health Planning Commission, in the 2001 edition of the National Medical Service Price Project Regulations (Trial) issued on October 24, 2000, CIK immune cell therapy was included, providing a legal basis for fees. In the first catalogue of the third category of medical technology that allowed clinical application, which was promulgated on June 11, 2009, autoimmune cells and stem cells were included, and stem cells actually gained legal status. Relevant companies naturally did not have the motivation to invest in the research and development of stem cell drugs, which laid a hidden danger for the chaos of clinical application of stem cells. As a result, on December 26, 2011, the notice on the development of stem cell clinical research and application self-examination and self-correction was promulgated. ", emergency call stem cell clinical research. On June 29, 2015, the Health and Family Planning Commission promulgated the “Notice on Cancellation of the Relevant Work on the Approval of the Clinical Application of the Third Class of Medical Technologyâ€, and delegated the main responsibility to the medical institutions. Without the endorsement of the government department, coupled with the "Wei Zexi" incident exposed in 2016, the era of cell treatment charges was terminated. Everything is back to the original point.
After drawing on the painful lessons of the past, SFDA and the Health Planning Commission cooperated to jointly promulgate the "Management Methods for Stem Cell Clinical Trial Research (Trial)" and "Management Methods for Stem Cell Clinical Trial Base (Trial)" on March 7, 2013. Draft for the "Quality Control of Stem Cell Preparations and Preclinical Research Guidelines (Trial)" was officially implemented on August 23, 2015. Preparation, quality control, preclinical studies, clinical trials, and related bases for stem cell preparations. Detailed regulations have been put in place to guide the approval of the marketing of stem cell drugs.
In addition, on December 1, 2015, the Health Planning Commission promulgated the “Notice on Carrying out the Recording Work of Stem Cell Clinical Research Institutionsâ€, which is open outside the drug declaration, allowing some institutions with relevant qualifications to conduct stem cell clinical research, but cannot charge, research results It can be used as a drug declaration to simplify the process of conducting stem cell clinical research. The first batch approved 42 hospitals, including 30 approved by the two committees and 12 approved by the Military Health Bureau, and a total of six clinical research projects were filed.
The joining of multi-disciplinary talents is the solution
In the movie "The World Without Thieves", Ge You's role has a classic line: "What is the most precious in the 21st century? Talent!" The same is true for stem cell drug development. At present, the leading force in the field of stem cell research is the research unit. Among the 68 major stem cell projects that were established in 2016 and 2017, none of the lead units is the company, highlighting the shortcomings of industrialization.
Compared with basic and clinical research, stem cell drug development is a huge systematic project involving cell culture, identification, preparation, quality control, preclinical research (pharmacology, toxicology, pharmacokinetics, pharmacokinetics, etc.), clinical trials, etc. Multiple links. In addition to scientists, there are very few talents with engineers and pharmacy backgrounds, and the addition of talents from multiple fields will produce synergies and promote the development of stem cell drugs.
The road is long and the road is long, and I will search for it. Going back to the title of the article, the author boldly predicts that China's first stem cell drug will be approved five years later. Of course, this estimate is largely based on the author's personal emotional factors, based on the most optimistic assumptions. As long as the field is improving, even if it is beaten in the future, there is nothing.
Source: Biopharmaceutical Xiaobian (Micro Signal Biopharm2016)
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