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Recently, Qihan BiotechAnnounced its self-developed product with global rightsThe First Universal, Dual-Target (CD19/BCMA) CAR-T Cell Product QT-019BThe clinical trial application for the new drug has received tacit approval from the National Medical Products Administration.QT-019B is the first universal dual-target CAR-T cell product independently developed by a Chinese company to have consecutively received implied approval from the U.S. FDA and China's CDE.Currently, its first indication is refractory systemic lupus erythematosus (rSLE).
QT-019B Targets Both CD19 and BCMA, Holds Promise for Meeting Medical Needs of Different Types of Autoimmune Diseases, Potentially Applicable to Various Antibody-Related Conditions. The Company Will Develop Indications Including Multiple Sclerosis (MS), Autoimmune Hemolytic Anemia (AIHA), and Idiopathic Inflammatory Myopathies (IIM), Based on Unmet Clinical Needs of Patients with Autoimmune Diseases, Investigator-Initiated Trial (IIT) Data, and Consideration of Regulatory Pathways for Different Indications, to Address the Broader Patient Population's Medical Needs.Qihan BiotechFounded by Dr. Luhan Yang and Professor George Church, Hangzhou Qihan Biotech Co., Ltd. is a biotechnology company dedicated to applying high-throughput gene editing technology in the fields of cell therapy and organ transplantation. It aims to provide safe, effective, scalable, and globally accessible treatment solutions for patients suffering from severe diseases.
Utilizing advanced gene-editing technologies and a profound understanding of transplant immunology, Qihan has established a unique "immune-compatible" cell and organ platform for producing next-generation cells and organs capable of evading host immune attacks, applicable to both allogeneic and xenogeneic transplants. In the allogeneic direction, the company is committed to generating various genetically modified human cells and tissues, including immune cells for immuno-oncology as well as islet cells, cardiomyocytes, and neuronal cells for regenerative medicine. In the xenogeneic direction, the company uses multi-gene-edited pigs as bioreactors to "produce" safe and effective xenogeneic organs, aiming to save patients in need of organ transplants.The company will also focus on developing the next generation of universal CAR-T products for the treatment of autoimmune diseases.CompanyCombined with recent patented research achievements, the goal is to reduce or eliminate the pre-treatment of lymphodepletion chemotherapy, achieving an ideal drug delivery model for treating autoimmune diseases with low/no lymphodepletion and a single-dose treatment. The product will gradually enter the investigator-initiated clinical trial phase, with plans to further advance the IND new drug development application in the future, aiming to create an ideal treatment solution that is lymphodepletion-free, safe, effective, and reasonably priced.Mastering CAR-T Therapy, Stem Cell Therapy, Gene
Therapy,Comprehensive Information on Oncolytic Viruses and Nucleic Acid Drugs
