Rewrite text
[Adroddodd gohebydd Times Guo Honghui yn Taipei]Changsheng (6712) has achieved a major breakthrough in the field of cell therapy. Recently the US Food and Drug Administration (FDA) officially approved its new drug CAR001 (CAR-T) to conduct Phase I /IIa clinical trials, becoming the first in the world The allogeneic HLA-G-CAR-BiTE cell therapy approved for human clinical trials has opened up a new era-making therapy for cancer treatment in advanced and refractory solid tumors (including colon cancer and rectal, breast, lung and brain cancer).
There are seven CAR-T products on the market globally. Currently, they target targets such as BCMA and CD19 by genetically modifying the patient’s autologous immune cells and then infusing them back into the patient to fight blood tumors. At present, CAR-T therapy has two major shortcomings, including 1. It has limited indications and has not been widely used in the treatment of solid tumors, and about 80% of cancers are related to solid tumors; 2. It must use autologous cells for transformation, and the preparation process takes about 1-2 months, and the quality is unstable and single The treatment costs US$400,000 (equivalent to NT$12 million) .
Despite this, the best-selling CAR-T product YESCARTA will still have sales of US$1.16 billion in 2022. The CAR-T market size is estimated to be US$18.61 billion in 2022 and will reach US$ 93.78 billion by 2030, with a compound annual growth rate (CAGR) of 22.4% between 2022 and 2030.
Changsheng collaborated with the research team of President Zhou Deyang of the Affiliated Medical College of China to develop the first-in-class CAR001 product, which is the result of years of detailed research by the research team. CAR001 uses artificial intelligence (AI) to select key targets of human solid tumor antigen-G leukocyte (HLA-G) and uses the innovative message RNA (mRNA) technology of CAR-T to test in preclinical animals More than 90% of tumors solid were eliminated in the experiment, and the relevant research results have been published in the best international journals many times, including the Journal for ImmunoTherapy of Cancer (JITC, IF 13.751) in 2021, and Advanced Science (IF17.521 ) in 2023. ).
General Manager Huang Wenliang noted that some challenges were encountered during the 30-day process of applying for clinical trials in the United States, but the research team worked hard and cooperated, and under the FDA’s request , an answer must be provided within 48 hours. , which is quite a tight schedule, but the company was able to advance the new drug to a Phase I/IIa clinical trial within 30 days. Currently, many pharmaceutical companies around the world are negotiating with Changsheng to authorize CAR001.
, make it unique and different from the original text, edit it to look like written by a professional journalist for a newspaper and make it grammatically correct content. Tone: Neutral. formal and professional. Use HTML for formatting, include h2 tags, h3 tags, lists and bold.
[Adroddodd gohebydd Times Guo Honghui yn Taipei]Changsheng (6712) has achieved a major breakthrough in the field of cell therapy. Recently the US Food and Drug Administration (FDA) officially approved its new drug CAR001 (CAR-T) to conduct Phase I /IIa clinical trials, becoming the first in the world The allogeneic HLA-G-CAR-BiTE cell therapy approved for human clinical trials has opened up a new era-making therapy for cancer treatment in advanced and refractory solid tumors (including colon cancer and rectal, breast, lung and brain cancer).
There are seven CAR-T products on the market globally. Currently, they target targets such as BCMA and CD19 by genetically modifying the patient’s autologous immune cells and then infusing them back into the patient to fight blood tumors. At present, CAR-T therapy has two major shortcomings, including 1. It has limited indications and has not been widely used in the treatment of solid tumors, and about 80% of cancers are related to solid tumors; 2. It must use autologous cells for transformation, and the preparation process takes about 1-2 months, and the quality is unstable and single The treatment costs US$400,000 (equivalent to NT$12 million) .
Despite this, the best-selling CAR-T product YESCARTA will still have sales of US$1.16 billion in 2022. The CAR-T market size is estimated to be US$18.61 billion in 2022 and will reach US$ 93.78 billion by 2030, with a compound annual growth rate (CAGR) of 22.4% between 2022 and 2030.
Changsheng collaborated with the research team of President Zhou Deyang of the Affiliated Medical College of China to develop the first-in-class CAR001 product, which is the result of years of detailed research by the research team. CAR001 uses artificial intelligence (AI) to select key targets of human solid tumor antigen-G leukocyte (HLA-G) and uses the innovative message RNA (mRNA) technology of CAR-T to test in preclinical animals More than 90% of tumors solid were eliminated in the experiment, and the relevant research results have been published in the best international journals many times, including the Journal for ImmunoTherapy of Cancer (JITC, IF 13.751) in 2021, and Advanced Science (IF17.521 ) in 2023. ).
General Manager Huang Wenliang noted that some challenges were encountered during the 30-day process of applying for clinical trials in the United States, but the research team worked hard and cooperated, and under the FDA’s request , an answer must be provided within 48 hours. , which is quite a tight schedule, but the company was able to advance the new drug to a Phase I/IIa clinical trial within 30 days. Currently, many pharmaceutical companies around the world are negotiating with Changsheng to authorize CAR001.
#Biomedical #Stocks #Changsheng #Allogeneic #CART #HLAG #Approved #Enter #Phase #IIIa #Clinical #Trials #Listing #Counter
