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Recent popular reports from Yimaike ★Boshengji’s application for a clinical trial of an autologous CD7-CAR-T product has been acceptedYimai Meng broke the news ★ Invitation to the event2021 Oncolytic Virus Drug Development Forum is about to open in Shanghai Click on the picture and sign up for 2021 May 27, 2021/MedClub News/--Since May 17, 2021, Boshengji Pharmaceutical has independently developed the world’s first nano-antibody-based autologous CD7-CAR-T cell injection (R&D code: PA3- 17 Injection) after the application for clinical trials was accepted by the Drug Evaluation Center of the State Drug Administration (Acceptance Number: CXSL2101087), on May 26, Boshengji another allogeneic CD7-CAR targeting CD7 targets -T cell injection was once again accepted by the Drug Evaluation Center of the National Medical Products Administration (acceptance number: CXSL2101097).
The injection is a CD7-targeted CAR-T cell drug produced by T lymphocytes from a patient's stem cell transplantation donor.
The indication is for relapsed/refractory CD7-positive hemolymphatic malignancies after allogeneic transplantation in adults.
▲ Picture source: Boshengji's CD7-positive malignant tumors Most of the CD7-positive malignancies are highly aggressive lymphomas or leukemias.
The disease progresses quickly and the prognosis is poor.
Most cases relapse within a short period of time after chemotherapy remission.
These diseases mainly include: T lymphoblastic leukemia/lymphoma (T-ALL/LBL), early pre-T lymphoblastic leukemia (ETP-ALL), extranodal NK/T cell lymphoma, and a variety of rare diseases and Rare diseases etc.
For the treatment of refractory and relapsed T-ALL/LBL, only the US FDA has approved nelarabine as its therapeutic drug in the world, but nelarabine has not yet been marketed in China, and the CR rate obtained is only 20 %-30%, the median survival time of patients under single-drug administration is only 8 months.
For refractory patients, the survival period of monotherapy is only as short as ~4 months.
Therefore, CD7-positive indications such as refractory and relapsed T-ALL/LBL represent an urgent clinical need to be met, and the advent of CD7-CAR-T cell therapy represents that this urgent clinical need is expected to be resolved.
Regarding allogeneic CD7-CAR-T cells, according to a study conducted by the General Hospital of the People’s Liberation Army of China, after allogeneic hematopoietic stem cell transplantation in T-ALL patients, the 5-year OS was only 38.
3%, and the transplant-related mortality rate was 20.
5%.
For patients with refractory and relapsed T-ALL, less than 10% of patients have the chance of allogeneic transplantation, but among these transplanted patients, only ~10% have the chance of long-term survival, and the rest All patients died shortly after transplantation, some patients died of transplant-related complications, and most patients died of recurrence after transplantation.
Therefore, for patients with tumors that relapse after transplantation, it is an urgent clinical need to be met.
The allogeneic CD7-CAR-T cells successfully developed by Boshengji adopts highly optimized automatic preparation process and significantly reduces the cost.
It is expected to become A new option for patients who relapse after transplantation.
Boshengji has been developing CD7 single domain antibodies since 2012.
It has successively carried out the research and development of CD7 immunotoxin and CD7-CAR-NK, and finally successfully developed the world's first CD7-CAR-T with First-in-class potential.
cell.
In 2020, Boshengji and Professor Zhang Mingzhi from the First Affiliated Hospital of Zhengzhou University, a clinical partner organization, respectively carried out pre-clinical research results and pre-clinical trial results (clinical research initiated by the investigator) at the European Hematology Association (EHA) meeting.
.
Regarding the development of high-quality cellular drugs that cancer patients really need, it is the vision and goal of Boshengji.
Boshengji Pharmaceutical Technology (Suzhou) Co.
, Ltd.
was established in 2010.
It is a national high-tech enterprise with breakthrough tumor cell immunotherapy technology and cell drug product research and development as its main development goals.The company focuses on the development of world-leading breakthrough First-in-class and Best-in-class CAR-T cell drugs to benefit cancer patients.
In 2012, the company received angel round investment from Suzhou Industrial Park Leading Venture Capital, Suzhou Industrial Park Venture Capital Guidance Fund, and other partners.
In 2015 and 2016, it received strategic investment from Anke Biology and established a focus on cell Boshengji Anke Cell Technology Co.
, Ltd.
for drug production and industrialization.
Recently, Boshengji Pharmaceutical Technology (Suzhou) and Boshengji Anke completed a major internal reorganization, and received a round of investment led by Yuansheng Venture Capital, Penguoxin Equity Investment and Xiantong Capital.
At the same time, the company is actively deploying the supply chain and cell preparation center in northern China, starting a new development journey.
With its first-class cell therapy drug research and development capabilities, fully automated CAR-T cell preparation technology, and advanced lentiviral vector industrial production system, Boshengji has successfully developed a number of cell products and entered the clinical verification phase, covering most of the blood Tumors and some solid tumors.
Among them, multiple cell drug candidates targeting T lymphoblastic leukemia/lymphoma, childhood neuroblastoma, etc.
, have initially shown encouraging efficacy and safety in clinical validation.
Since its establishment, Boshengji has established a high-level and professional first-class R&D team, and won the second prize of China Innovation and Entrepreneurship Competition, the first prize of Chuangxiang China Anhui Innovation and Entrepreneurship Competition, Jiangsu Double Innovation Talents, Gusu Innovation and Entrepreneurship Leadership, Suzhou Industrial Park Technology Leadership, Anhui Province Strategic Emerging Industry Technology Leadership, Hefei City Entrepreneurship Leadership, Luzhou Industrial Innovation Team and other honorary titles.
Boshengji hopes to work together with everyone to realize the Huimin plan of cell drugs with Chinese independent intellectual property rights, affordable for cancer patients, and excellent curative effects! For details, please visit the company's website: www.
persongen.
com.
cn Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights in bio-innovative drugs.
The high-end matrix users of all media reach 160,000+, of which industrial users account for Over 50%, approximately 30% of scientific research and clinical users, and over 5% of users in investment institutions. In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
The injection is a CD7-targeted CAR-T cell drug produced by T lymphocytes from a patient's stem cell transplantation donor.
The indication is for relapsed/refractory CD7-positive hemolymphatic malignancies after allogeneic transplantation in adults.
▲ Picture source: Boshengji's CD7-positive malignant tumors Most of the CD7-positive malignancies are highly aggressive lymphomas or leukemias.
The disease progresses quickly and the prognosis is poor.
Most cases relapse within a short period of time after chemotherapy remission.
These diseases mainly include: T lymphoblastic leukemia/lymphoma (T-ALL/LBL), early pre-T lymphoblastic leukemia (ETP-ALL), extranodal NK/T cell lymphoma, and a variety of rare diseases and Rare diseases etc.
For the treatment of refractory and relapsed T-ALL/LBL, only the US FDA has approved nelarabine as its therapeutic drug in the world, but nelarabine has not yet been marketed in China, and the CR rate obtained is only 20 %-30%, the median survival time of patients under single-drug administration is only 8 months.
For refractory patients, the survival period of monotherapy is only as short as ~4 months.
Therefore, CD7-positive indications such as refractory and relapsed T-ALL/LBL represent an urgent clinical need to be met, and the advent of CD7-CAR-T cell therapy represents that this urgent clinical need is expected to be resolved.
Regarding allogeneic CD7-CAR-T cells, according to a study conducted by the General Hospital of the People’s Liberation Army of China, after allogeneic hematopoietic stem cell transplantation in T-ALL patients, the 5-year OS was only 38.
3%, and the transplant-related mortality rate was 20.
5%.
For patients with refractory and relapsed T-ALL, less than 10% of patients have the chance of allogeneic transplantation, but among these transplanted patients, only ~10% have the chance of long-term survival, and the rest All patients died shortly after transplantation, some patients died of transplant-related complications, and most patients died of recurrence after transplantation.
Therefore, for patients with tumors that relapse after transplantation, it is an urgent clinical need to be met.
The allogeneic CD7-CAR-T cells successfully developed by Boshengji adopts highly optimized automatic preparation process and significantly reduces the cost.
It is expected to become A new option for patients who relapse after transplantation.
Boshengji has been developing CD7 single domain antibodies since 2012.
It has successively carried out the research and development of CD7 immunotoxin and CD7-CAR-NK, and finally successfully developed the world's first CD7-CAR-T with First-in-class potential.
cell.
In 2020, Boshengji and Professor Zhang Mingzhi from the First Affiliated Hospital of Zhengzhou University, a clinical partner organization, respectively carried out pre-clinical research results and pre-clinical trial results (clinical research initiated by the investigator) at the European Hematology Association (EHA) meeting.
.
Regarding the development of high-quality cellular drugs that cancer patients really need, it is the vision and goal of Boshengji.
Boshengji Pharmaceutical Technology (Suzhou) Co.
, Ltd.
was established in 2010.
It is a national high-tech enterprise with breakthrough tumor cell immunotherapy technology and cell drug product research and development as its main development goals.The company focuses on the development of world-leading breakthrough First-in-class and Best-in-class CAR-T cell drugs to benefit cancer patients.
In 2012, the company received angel round investment from Suzhou Industrial Park Leading Venture Capital, Suzhou Industrial Park Venture Capital Guidance Fund, and other partners.
In 2015 and 2016, it received strategic investment from Anke Biology and established a focus on cell Boshengji Anke Cell Technology Co.
, Ltd.
for drug production and industrialization.
Recently, Boshengji Pharmaceutical Technology (Suzhou) and Boshengji Anke completed a major internal reorganization, and received a round of investment led by Yuansheng Venture Capital, Penguoxin Equity Investment and Xiantong Capital.
At the same time, the company is actively deploying the supply chain and cell preparation center in northern China, starting a new development journey.
With its first-class cell therapy drug research and development capabilities, fully automated CAR-T cell preparation technology, and advanced lentiviral vector industrial production system, Boshengji has successfully developed a number of cell products and entered the clinical verification phase, covering most of the blood Tumors and some solid tumors.
Among them, multiple cell drug candidates targeting T lymphoblastic leukemia/lymphoma, childhood neuroblastoma, etc.
, have initially shown encouraging efficacy and safety in clinical validation.
Since its establishment, Boshengji has established a high-level and professional first-class R&D team, and won the second prize of China Innovation and Entrepreneurship Competition, the first prize of Chuangxiang China Anhui Innovation and Entrepreneurship Competition, Jiangsu Double Innovation Talents, Gusu Innovation and Entrepreneurship Leadership, Suzhou Industrial Park Technology Leadership, Anhui Province Strategic Emerging Industry Technology Leadership, Hefei City Entrepreneurship Leadership, Luzhou Industrial Innovation Team and other honorary titles.
Boshengji hopes to work together with everyone to realize the Huimin plan of cell drugs with Chinese independent intellectual property rights, affordable for cancer patients, and excellent curative effects! For details, please visit the company's website: www.
persongen.
com.
cn Yimike has always been committed to original news reports such as cutting-edge technology, industry trends, and industry insights in bio-innovative drugs.
The high-end matrix users of all media reach 160,000+, of which industrial users account for Over 50%, approximately 30% of scientific research and clinical users, and over 5% of users in investment institutions. In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups.
