On the afternoon of 20 August 2020, Shenzhen Children's Hospital invited Dr. Hu Junyuan, Chairman of Shenzhen Beike Biotechnology Co., Ltd., to deliver a thematic lecture on "Clinical Translation and Application Prospects of Cell Therapy". The lecture focused on three core themes – "people", "technology" and "life" – and provided an in-depth interpretation of frontier areas including cell therapy, life sciences and the biopharmaceutical industry. Led by President Ma Xiaopeng, experts, department heads and physicians from many departments of the hospital attended for exchange and learning.
President Ma said: "Cell therapy is currently one of the most popular and promising therapies internationally. Regenerative medicine, exemplified by stem cells, has produced a number of research outcomes in recent years. For Shenzhen Children's Hospital, which similarly seeks to embrace future technologies and to improve and break through existing medical practice, this offers a great deal worth learning and drawing on. We hope that through this learning our medical staff will gain new ideas, broaden their thinking, further strengthen and break through in scientific research, and enable biomedical technologies to bring good news to more children with intractable diseases!"
(Lecture by Dr. Hu Junyuan of Beike Biotech)
Cell therapy is the development direction of new medicine in the 21st century. In recent years, China has placed great emphasis on cell therapy research and clinical translation. National regulators and local authorities have continuously issued policies and increased financial and human-resource support for stem cell research and clinical translation. In the area of stem cell new drugs, China has developed the "Technical Guidelines for the Research and Evaluation of Cell Therapy Products (Trial)" and the new system of "60-day implicit clinical trial approval", providing new development opportunities for the R&D and registration of stem cell new drugs in China.
Against this backdrop, the new drug clinical registration application for the product "Human Umbilical Cord Mesenchymal Stem Cells for Injection for the Treatment of Refractory Systemic Lupus Erythematosus", independently developed by Beike Biotech, was officially accepted by the Center for Drug Evaluation of the National Medical Products Administration. This stem cell new drug is China's first stem cell product targeting refractory systemic lupus erythematosus.
Dr. Hu Junyuan noted: "Cell therapy is developing rapidly. To date, more than 40 stem cell therapy products have been approved globally; in China, more than 10 stem cell products have been accepted by the drug regulator since 2018. The National Health Commission has filed 108 stem cell clinical research institutions, including 12 military hospitals."
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To date, Beike Biotech has cooperated with 5 hospitals to apply for and obtain stem cell clinical research institution filings from the National Health Commission, including the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Peking University Shenzhen Hospital, Shenzhen People's Hospital, the Second Affiliated Hospital of Kunming Medical University and Taihe Hospital in Shiyan, Hubei.
The company has also accumulated rich clinical experience and clinical research outcomes in mesenchymal stem cell therapy for difficult pediatric conditions. The project "Clinical Research on the Safety and Efficacy of Human Umbilical Cord-Derived Mesenchymal Stem Cells Combined with Modern Rehabilitation in the Treatment of Pediatric Cerebral Palsy", jointly applied for with Taihe Hospital in Shiyan, Hubei, has been filed with the National Health Commission as a stem cell clinical research project, and recruitment for the clinical research began in June 2020.
At the same time, during this year's COVID-19 pandemic, Beike Biotech has actively participated in the response, securing project approval under the Guangdong Department of Science and Technology's "Emergency Special Project on Scientific and Technological Tackling for the Prevention and Control of Novel Coronavirus Infection" and under the Kunming Science and Technology Bureau's "Special Project on Scientific and Technological Prevention and Control of Novel Coronavirus Pneumonia". The project led by Beike Biotech, "Drug Development for Mesenchymal Stem Cell Therapy of COVID-19", was successfully selected as a recommended project under the "Guangdong Science and Technology Helping the Economy 2020" key special project.
