Recently, according to the public information on the NMPA official website, the KL003 cell injection independently developed by Kanglin Biotechnology (Hangzhou) Co., Ltd. successfully obtained the NMPA’s implicit clinical trial license, with the acceptance number CXSL2300699, and is clinically used to treat transfusion-dependent beta in adults or children. -Thalassemia.

The microspectrum biosafety service platform provides cell bank testing and strain library testing services for this product.

β-thalassemia is a hemolytic anemia caused by defects or mutations in the β-globin gene (Hemoglobin β, HBB) on chromosome 11, resulting in partial or complete loss of β-globin-related functions, which brings great consequences to the patient’s life and health. The patients is more common in children and adolescents. Traditional treatments for thalassemia (blood transfusion, hematopoietic stem cell transplantation, etc.) are accompanied by side effects that cannot be ignored. The vast majority of patients lack the opportunity for radical cure, and there are obvious unmet treatment needs.

KL003 Cell Injection is a genetically modified autologous hematopoietic stem cell product that transduces autologous hematopoietic stem cells with β-globin gene mediated by lentiviral vectors and infuses them back into the patient’s body to differentiate into red blood cells expressing normal β-globin function and restore the patient’s health. The patient's hemoglobin level can help him get rid of blood transfusion dependence and achieve one-time functional cure. KL003 cell injection has successfully treated 17 patients in the researcher-initiated (IIT) clinical study. The earliest patient to receive treatment has been free of blood transfusion for more than 2 years.

The Microspectral Biosafety Service Platform provides professional cell bank testing and strain library testing services for customers whose KL003 cell injection IND is approved.

At present, we have obtained BSL-2 laboratory certification, and have successively won ISO9001, CMA, CNAS and other qualification accreditations and certifications. Our business capabilities cover cell/virus/strain library construction, cell bank/strain bank/virus bank testing, virus Carrier analysis, virus clearance verification, UPB release, etc. can provide integrated biosafety solutions for biotechnology products that meet the requirements for drug registration and declaration in China, the United States, and European markets.

Microspectrum Biotechnology has always established a high-quality service system and polished customized research plans based on domestic and foreign declarations. So far, it has more than 200 successful project experiences and has received unanimous recognition and praise from customers.

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