Global stem cell drug newly approved for market interpretation.

Text . . . Ke Zhikang for a long time, stem cells have been pinning people's great dream of tackling disease and benefiting human health.
over the past 20 years, stem cell drug research has yielded fruitful results.
Since the first broad stem cell drug Chondron was approved for sale in Korea in 2001, today, in addition to 10 hematopoietic stem cell drugs, the world's listed stem cell drug varieties have reached 31, more than 1.5 years.
for a variety of reasons, stem cell drugs have not yet appeared in small molecular and antibody drugs sales of hundreds of millions or even more than 1 billion dollars of "heavy bomb" varieties, but in any case, the accumulation of the unknown, today's accumulation will lay a solid foundation for tomorrow's hair.
this paper summarizes the latest global stem cell drug approvals for the benefit of readers.
. The overall overview is shown in the table 1 below, as of June 30, 2020, there are 41 stem cell drugs approved for sale worldwide, covering the United States (11), Europe (7), Japan (5), South Korea (12), India (3), Australia (2), Canada and New Zealand (the same one).
in China, hematopoietic stem cells (HSC) and hematopoietic progenitor cells (HPC) are excluded from the scope of cell products, so the stem cell drug types counted below will not include HSC or HPC, involving 10 approved U.S. (8) and European (2) stem cell drugs (see Table 1 above).
as shown in figure 1 below, 35 stem cell drugs have been approved for global market in the 20 years from 2001 to the present.
, one variety in Japan and South Korea was approved for different indications in three and two years respectively, and in 2012 in Canada and New Zealand were approved for the same variety, so in fact there are 31 stem cell drugs in the city, with an average annual approval of about 1.55 varieties.
, excluding the number of varieties approved for different indications or approved in two countries, was the largest in 2010, 2012 and 2015, with four each;
the eight years totaled 24, accounting for 77.4% of the total, with an average of three per year.
1 variety has been approved in each of the other years listed (see figure 1 above).
2. Species Profile 1, Variety Type in the 31 stem cell drug varieties approved for listing, from the nature or source, including the dry-doing of various types of tissue stem cells and relatively weak tissue precursor cells or progenitor cells two categories, each 10 and 21, respectively, close to the number of approved stem cell drugs listed 1/3 and 2/3 (see figure 2).
, the largest varieties of epithelial cells are made of fibrous/cagotic cells (FB/KB), cartilage cells, bone marrow interstitial stem cells (BMSC), interfatuated stem cells (ADSC), osteoblasts (OB) and corneal epithelial cells, each with 8 (255) 8 percent), 6 (19.4%), 6 (19.4%), 3 (9.7%), 2 (6.5%) and 2 (6.5%), for a total of 27, accounting for 87.1% of the total number of 31 listed varieties.
1 variety of other types, including umbilical cord-to-prostothetic stem cells (UCMSC), interstitial precursor cells (MPC), myoblast-derived cell tablets (MBDCS), and bone marrow-derived endothelial progenitor cells (BMDEPC) (see figure 2 above).
2, indications from the following figure 3 can be seen, 31 listed stem cell drugs for a total of 22 approved indications, according to indications statistics cumulative number of 35 varieties.
approved indications of the corresponding number of 5 species listed, including cartilage injury and defect (CID), burns, transplant anti-host disease (GvHD), acute myocardial infarction (AMI) and Crohn's disease caused by fistula (PAF), respectively, 7, 5, 2, 2 and 2, a total of 18, accounting for 58.1% of the total number of listed varieties, accounting for 51.4% of the cumulative statistics.
17 other approved indications each correspond to one listed variety, including arthritis, surgical vascular trauma (SVI), moderate and severe nasal groove wrinkles (NLF), diabetic foot ulcer (DFU), acne scars (AS), spinal cord injury (SCI), amyotrophic lateral sclerosis (ALS), ischemic heart disease (IHD), and giant congenital melanin cell (GCMN) (see figure 3 above).
3. Country Profile 1, the United States from 2011 to date, in addition to 8 allogeneic cord hematopoietic progeny cell (HACC-HPC) varieties, the United States has a total of 3 stem cell drugs listed, are tissue precursor cell sources, respectively: Laviv (Azficel-T), treatment of adult stylus wrinkles, self-made human fibroblast products, 2011 Gintuit, treatment of adult membrane gum surgery for wounding of blood vessels, was approved in 2012 for exfoliator and fibroblast products cultured on the bovine collagen matrix; MACI, treatment of adult cartilage defects, for the self-made human cartilage cell product strained on pig collagen matrix, 2016 (see approved table 2).
2. Since 2009, in europe, in addition to two CD34-plus artificial blood stem cells and their gene therapy products, there are 5 stem cell drugs on the market in Europe, four of which are tissue precursors or progenitor cells and one is tissue stem cells.
4 of the five varieties were approved under the EU EMA centralized review system and one (T2C-001) was approved under the national review system of member States (see table 3 below).
approved in 2009, ChondroCelect, is the first stem cell drug listed in Europe, the review obtained THE EMA advanced therapy, is a treatment of adult knee femur sciatica single with symptomatic cartilage damage of the self-contained human cartilage cell products, has been withdrawn from the European market for commercial reasons.
the other four listed drugs are: T2C-001, treatment of myocardial infarction, self-contained human bone marrow-derived endothelial progenitor products, approved in Germany in 2010; Approved; Spherox, treatment of knee cartilage defects, in vitro cultured autologous human matrix-related cartilage cell ball products; Alofisel (Darvadstrocel), treating complex fistula caused by Crohn's disease, and allogeneic interfat-filling stem cell products, approved in 2018. The last three
varieties were identified as EMA orphan medicine in the review (see table 3 above).
3, Japan from 2007 to date, Japan has listed a total of 5 stem cell drugs, including tissue precursor cell source cell chip products 3, bone marrow interstitial stem cell products 2.
as a self-contained human epidermis derived cell chip products, JACE is the world's largest listed stem cell drugs approved of the single variety of indications;
the species received PMDA orphan drug identification and priority review (see table 4 below).
this year, an autonomous corneal epithelial cell tablet product derived from the cornea edge used to treat corneal damage was recently launched in Japan.
the other three listed varieties are: HeartSheet, which treats ischemic heart disease with severe heart failure, self-skeletal muscle-forming cell-derived cell tablets, approved in 2015;
4, South Korea from 2001 to date, South Korea listed a total of 12 stem cell drugs, fruitful results.
, tissue precursor cell products have 8, accounting for 2/3, stem cell products have 4, accounting for 1/3.
are used for the treatment of 10 types of indications, of which the largest number of burns involved, four, are human cartilage cell source products;
in eight tissue precursor cell drugs, specific products and indications involved include: Chondron, cultured in-human cartilage cell products for the treatment of knee cartilage defects; degree burns; RMS Ossron, cultured in-human osteoblast products for the treatment of osteoblast ationoblastic bone formation; Kaloderm, an asosome-adult keratin cell-derived cell chip product for the treatment of deep 2 degree burns and diabetic foot ulcers; and more (see Table 5 above for details).
of the four tissue stem cell drugs, specific products and related indications include: Neuronata-R and Hearticellgram-AMI, the source of self-contained human bone marrow-in-line stem cell sources, respectively, the treatment of atrophic lateral sclerosis (ALS) and acute myocardial infarction (improved LVEF), which is the world's first stem cell drug for the treatment of cardiac indications; Em, human umbilical cord-replenishing stem cell products for the treatment of degenerative arthritis and knee cartilage injury; Cupistem, anthropotic stem cell product for the treatment of fistula due to Crohn's disease; and Darvadstrocel, a similar product to its adaptation (see tables 3 and 5 above).
5, other countries with global stem cell drugs on the market, India, Australia, New Zealand and Canada, respectively, approved three, two, one variety.
, there are 4 tissue precursor products, 2 bone marrow-to-steme-filling stem cell products, and 5 types of indications (see table 6).
two of the four tissue precursor stem cells listed on the market, india and Australia each. two varieties approved in
India were approved in 2017: Ossgro (Ossron ABI), an infra-cultured human osteoblast product for the treatment of hip ischemic necrosis, and Cartigro (Chondron ACI), a cultured homologous human cartilage cell product for the treatment of joint cartilage deficiencies.
Two varieties approved in Australia in 2010 and 2017 are: MPC, an autonomous human preplasithas product for damaged tissue repair and regeneration, ortho-ACI, an autonomous human cartilage cell product for cartilage and joint repair.
two osteogenic bone marrow-filled stem cell drugs listed, Stempeucel is a drug approved in India in 2016 for the treatment of severe lower limb ischemia caused by Buerger disease, and another species, Prochymalre-L, was approved in Canada and New Zealand in 2012 for the treatment of acute transplant resistance to host disease in children (see table 6 above).
. 4, The experts of Kezhikang concluded that in the United States, Europe, Japan and South Korea, which are more advanced in stem cell drug research, the exploration of stem cell drug research objects has completed the initial "primitive accumulation", and the basis for further research is better.
from the approved type of market, in recent years, the listed products from the relatively weak tissue precursor cells or progenitor cells to various types of tissue stem cells transition. strong
of dryness means that there is strong differentiation potential, for some of the complex and difficult to treat major diseases, the need to market such potential tissue stem cell products.
from the perspective of the drug targeted by the drug, the product has been gradually to overcome the serious threat to human health of certain major diseases, such as the treatment of spinal cord injury (SCI), amyotrophic lateral sclerosis (ALS) and ischemic heart disease (IHD) and other varieties have begun to market.
in short, future research and development of stem cell drug registration will extend in both depth and breadth.
depth includes the exploration of the quality and process of stem cells themselves and their derivatives such as exosomes, as well as an in-depth study of the mechanisms of indications;
expects registration declarations and approvals to be tilted towards the above.
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