Review Criteria
1, R&D Strength Analysis:
Stem Cell Drug Clinical Filing, Pre-IND, IND;
2, Industry Chain Analysis:
Enterprise Layout, National Layout, Industrial System;
3, Cell Quality Standards:
Qualification of Stem Cell Repositories and Preparation Centers Certification, preparation standards, quality control, process system construction;
3. Enterprise reputation:
Safety accident research, customer evaluation, etc.
4. Outstanding industry contribution:
Industry innovation, industry standardization, historical status, future value assessment, and world influence;
First place Beike Biologicals
To be on the list! Reason
It is a representative enterprise in China's stem cell field, which has long represented China's stem cell field in dialog with the international community, and has been a key concern enterprise for successive central leaders. At present, it has covered 7 countries globally and stem cell storage and preparation centers in 8 provinces in China.
China's first enterprise in mainland China to have passed the AABB (Advanced Alliance for Cellular Therapy and Blood Transfusion) standards, including "human umbilical cord blood-derived hematopoietic stem cells", "human umbilical cord-derived MSCs", "human umbilical cord-derived MSCs", "human stem cells", "human stem cells", "human stem cells", "human stem cells" and "human stem cells". "Human placental meconium-derived mesenchymal stem cells", "human peripheral blood-derived immune cells" from cell collection, cell preparation, cell storage, to cell therapy and blood transfusion, including "human umbilical cord blood-derived hematopoietic stem cells", "human umbilical cord-derived mesenchymal stem cells", "human placental meconium-derived mesenchymal stem cells", "human peripheral blood-derived immune cells" from cell collection, cell preparation, cell storage, to cell therapy and blood transfusion. We have been certified for the whole system of cell collection, cell preparation, cell storage, and cell distribution. We have also participated in the development of the AABB standard for human umbilical cord-derived mesenchymal stem cells.
In 2015, he participated in the formulation of standards for cell banks and preparation centers in Shenzhen, the evaluation of the titles of cell preparation personnel, and the construction of a third-party "cell quality testing platform", which made an indelible contribution to the establishment of quality standards for China's stem cells and the clarification of industry norms.
Beike's clinical projects:
Multicenter randomized, blinded and controlled study of umbilical cord mesenchymal stem cell therapy for lupus nephritis, Zhongshan Hospital, Fudan University
Multicenter randomized, blinded and parallel controlled study of umbilical cord mesenchymal stem cell therapy for lupus nephritis, Nanjing Gulou Hospital (Second Prize of the National Scientific and Technological Progress)
Different Transplantation Paths A randomized, parallel, controlled clinical study on the safety and efficacy of human umbilical cord mesenchymal stem cells for the treatment of type 2 diabetes mellitus Peking University Shenzhen Hospital
Clinical study on the clinical application of umbilical cord mesenchymal stem cells for the treatment of moderately severe and refractory systemic lupus erythematosus Anhui Provincial Hospital
A clinical study on the safety and efficacy of mesenchymal stem cells derived from the human umbilical cord in combination with modern rehabilitation for the treatment of children with cerebral palsy Clinical Study Shiyan Taihe Hospital
Prospective, Randomized, Controlled Clinical Study of Human Umbilical Cord-derived Mesenchymal Stem Cell Injection for the Treatment of Diabetic Foot Wounds Affiliated Hospital of Xuzhou Medical University
Second Place Zhongyuan Xiehe
Reason for the List
China's stem cell main board representative listed company, listed on a large-scale layout of the stem cell and cellular therapy segment. With advanced cell technology and nationwide cell resource storage network, the cell storage capacity has exceeded 300,000 copies, and it is one of the important national cell technology product development and transformation bases. Through its capital advantage, it is becoming a major force in China's biomedical industry group.
Chinosource clinical filed projects:
Clinical study of human umbilical cord mesenchymal stem cell treatment of neuropathic pain
Partnership Hospital of Tongji Medical College, Huazhong University of Science and Technology
Randomized, double-blind, controlled clinical study of human umbilical cord-derived mesenchymal stem cell treatment of cirrhosis of viral hepatitis B (in compensated stage)
Wuhan University People's Hospital
Randomized double-blind controlled clinical study of human umbilical cord-derived mesenchymal stem cells (UC-MSC) in slowing down the progression of renal function in patients with chronic kidney disease (CKD stage 3 and 4)
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Clinical study of the effect of umbilical cord-derived mesenchymal stem cells on the regenerative effects of liver on patients with cirrhosis in decompensated stage of hepatitis B
Lanzhou University The First Hospital of Lanzhou University
Single-center, open clinical study of human dental pulp mesenchymal stem cell injection for the treatment of moderate-to-severe plaque-like psoriasis (phase Ⅰ/Ⅱa) The First Affiliated Hospital of Jilin University
Third place Jiachenhong
Reason for the list
Jiachenhong, a high and new technology enterprise certified by the Beijing Municipal Science and Technology Commission, is specializing in technical consulting, technical training, and technical support for the freezing and storage of umbilical cord blood hematopoietic stem cells. The "Beijing Cord Blood Hematopoietic Stem Cell Bank", which was set up jointly with the Institute of Hematology of Peking University in 1996, is the earliest and largest umbilical cord blood hematopoietic stem cell bank in China, which has provided a large number of successful cases of transplantation. At present, the cord blood bank stores nearly 10,000 umbilical cord blood, and the public **** blood bank has provided 64 umbilical cord blood for more than 60 cases of unrelated cord blood hematopoietic stem cell transplantation, with an implantation success rate of 84%. It is currently the leading company in China focusing on "hematopoietic stem cell transplantation".
Fourth place: Sibiman
Reason for listing
Sibiman Biotech Group (NASDAQ: CBMG) is a Delaware-registered, NASDAQ-listed, China-focused cellular therapeutics company that is developing adult stem cells for use in regenerative medicine.
CBMG's clinical programs:
CBMG has completed a Phase IIb trial in China of autologous human adipose mesenchymal progenitor cells (haMPC) for the treatment of knee osteoarthritis (KOA)
Phase I trial in China of allogeneic human adipose mesenchymal progenitor cells (haMPC) for the treatment of KOA.
IND:
Autologous Human-derived Adipose Mesenchymal Progenitor Cells Injection New Drug Class 1
CBM-ALAM.1 Allogeneic Human-derived Adipose Mesenchymal Progenitor Cells Injection New Drug Class 1
Fifth: Ronghui Renhe
Reason for the List
Shenzhen Ronghui Renhe Life Technology Co. Ltd. is a life science industry project ecosystem investment and operation of innovative enterprises.
Ronghui Renhe Group has launched an innovative bio-industry ecological platform, dividing the company into two business groups: biomedical and life health. The Bio-pharmaceutical Experimental Group has set up a "Central Laboratory, CDMO, CMC, CRO, GCP, GLP" center in Chengdu, which is capable of completing drug declaration through drug acceleration and venture capital. The Life & Health Business Group has established an innovation service system with "LIFE'S ARK" as the core. It is an innovative company with new layout in the industry.
At present, Ronghui Renhe Group has been put into operation and is building the industrial ecosystem projects are:
①Shenzhen University / Beike Ronghui - Life Industry Technology Innovation Center, is the industry, academia, research and medical benchmark project;
②Ronghui Intelligence is responsible for the research and development of the cell preparation robot, production, and has completed the first generation of cell preparation robotic products;
3
③Beike Ronghui (Dongxiang) company, the construction of the world's largest cell backup library in Guizhou Health Industrial Park;
④Beike Guizhou, Zunyi, Beike Ronghui in Guiyang Guanshanhu and Zunyi Honghuagang construction of AABB full-system certification of the "Beike (Guiyang) integrated cell library and cell preparation center", Zunyi-Life Ark, which has been put into operation. Life Ark, which has been put into operation;
5) "Peach Blossom Stream - Life Valley" and Medical Tourism and Stem Cell Anti-Aging Center in Meitan, Zunyi, which has been approved by five ministries and commissions, including the Development and Reform Commission of the National Healthcare Commission, to become a national health tourism demonstration base;
6) "Beike Ronghui Life Bank and Life Preparation Center", which has been built with Guizhou University of Finance and Economics, with the full system certification of AABB. The "Beike Ronghui College of Life and Health Management" started to enroll undergraduates in 2017;
7. The "Chengdu Langgu", which is controlled by the chairman of Ronghui Renhe Group, cooperates with West China Hospital and the team of academician Wei Yuquan from the State Key Laboratory of Biotherapy of Sichuan University, and former FDA Lifetime Achievement Award Winner***, and is a joint venture of the "Chengdu Langgu", which is owned by the chairman of Ronghui Renhe Group. "Chengdu Langgu" is located in Chengdu Hi-tech Zone Frontier Medical Park, which is the production base for scientific research, clinical trials and cellular drugs of cell therapy of Ronghui Renhe Group.
8 Life Ark Laboratory is a synthetic biology innovative scientific research project based on the biological research education of young people under Ronghui Renhe Group.
RIT:
Research on the Effect of Allogeneic Placenta Amniotic Stem Cells on Premature Ovarian Failure Affiliated Hospital of Zunyi Medical University
Research on the Combined Use of Allogeneic Placenta Amniotic Stem Cells and Exosomes on Knee Degenerative Diseases Affiliated Hospital of Zunyi Medical University
IND:
CD34+ in Patients with Critical Limb Ischemia TRI Research Institute of Japan
COMET for severe ocular surface disease TRI Research Institute, Japan
Sixth place: Cord Blood Bank of Guangdong Province
Reasons for the list
Because of its technological apex, professional staff, advanced equipment, reliable quality and remarkable results, it has been certified by the state as a high and new-technology enterprise, with the technical capability of a variety of stem cell extraction and preparation, and has conducted research on the use of umbilical cord blood in the treatment of severe limb ischemia in a variety of colleges and medical institutions. We have cooperated with a number of universities and medical institutions in the research of cord blood.
Guangdong Cord Blood Bank has obtained AABB certification for the whole system of cord blood procurement, processing and storage.
Seventh place: Burson-Marsteller
Reasons for listing
Burson-Marsteller's four brands - Burson-Marsteller, Perception Medical, Perception Pharmaceuticals, and Burson-Marsteller - encompass a wide range of business pipelines, including cellular storage and clinical applications, automated cellular medical devices, cellular therapeutic technology research and development, and research and development and industrialization of animal breeding technology.
Boyal Stem Cell Bank has obtained AABB certification for the entire system of procuring, processing and storing of human umbilical cord-derived mesenchymal stem cells.
Boyer's Clinical Programs:
Boyer has an FDA-approved Phase III clinical trial of autologous stem cell technology for the treatment of critical limb ischemia (CLI)
Boyer has an FDA-approved and marketed autologous cell technology for the treatment of difficult-to-heal wounds
Eighth: Han's United
Reason for Listing
Beijing Founded in 2007, Han's United Biotechnology Company Limited ("Han's United") is a state-recognized high-tech enterprise. As a pioneer in the stem cell industry, HANS United is committed to the development of human life and health. With stem cell regenerative medicine technology as the core, HANS United has gradually formed a medical and healthcare platform dominated by new stem cell drug development, perinatal stem cell storage, and full-process integrated CDMO services, aiming to create a closed loop of the whole industry chain of stem cell regenerative medicine. The cell bank business has been laid out in many provinces and cities in China.
HAN's joint clinical record projects:
Human placental mesenchymal stem cell gel for diabetic foot ulcers Jing Tongren Hospital / Wuhan Zhongnan Hospital / First Affiliated Hospital of Nanchang University
Highly active human umbilical cord mesenchymal stem cell injections for the treatment of severe lower limb ischemia Reims University Medical Center, France
Injectable mesenchymal stem cells (umbilical cord) for refractory acute Graft-versus-host disease Union Hospital of Fujian Medical University (Tianjin Onsai)
Ninth place: Jiuzhitang Meike
Reasons for the list
Jiuzhitang Meike (Beijing) Cellular Technology Co., Ltd. (Stemedica) and its partners conducted eight stem cell clinical trials in the U.S. in the treatment of ischemic stroke, skin photodamage, non-ischemic Chronic Heart Failure, Alzheimer's Disease, Traumatic Brain Injury, Heart Failure Requiring LVAD Implantation, Acute Heart Attack, and Lung Injury Caused by Neocoronary Pneumonia, of which Ischemic Stroke and Chronic Heart Failure have already completed their Phase IIa clinical trials and have published a number of high level academic papers, and Alzheimer's Disease is the first U.S. clinical trial to be approved for the treatment of this disease using stem cells. In addition, Stemedica has also conducted 11 clinical trials in Switzerland, Kazakhstan, Mexico, China and other countries, of which the clinical trial for the treatment of acute myocardial infarction with it-hMSC produced by Stemedica has been completed and approved for marketing by the Ministry of Health of Kazakhstan in September 2018.
Clinical filings:
Ischemia-tolerant human allogeneic bone marrow mesenchymal stem cells
First FDA-approved clinical trial using stem cells to treat Alzheimer's disease
IND:
Ischemia-tolerant human allogeneic bone marrow mesenchymal stem cells New Drug Class 1
Tenth place: selera
Reason for listing
Guangzhou Sailailaila Stem Cell Technology Co., Ltd (stock code: 831049) is the first stem cell listed company on China's New Third Board.
Guangdong Province (Sailaila) Regional Cell Preparation Center (hereinafter referred to as the Preparation Center) is a provincial-level regional cell preparation center built by Saila Stem Cell, which is approved by the Guangdong Provincial Development and Reform Commission, Provincial Science and Technology Department, Provincial Health and Family Planning Commission, and Provincial Food and Drug Administration by a joint letter of the Guangdong Provincial Development and Reform Commission, Provincial Science and Technology Department, Provincial Health and Family Planning Commission, and Provincial Food and Drug Administration.