TopNovo Submits IND for TX103 CAR-T Therapy Targeting Solid Tumors, Receives FDA Orphan Drug Designation for Malignant Glioma

Nov 01, 2023 17:07 CST Updated 17:07

Tcelltech

Developer of Immuno-oncology and Cell Therapy Drugs

On October 31, according to the official website of CDE,Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. (referred to as "Tuoxin Tiancheng") has submitted a clinical application for its TX103 Chimeric Antigen Receptor T-cell Injection.TX103 is a CAR-T cell drug targeting B7-H3, which has demonstrated excellent safety and efficacy signals in early clinical trials for the treatment of recurrent malignant glioma., approved for clinical trials in both China and the U.S.,And received FDA orphan drug designation in June this year,For the treatment of malignant glioma.

▲ Image Source: CDE

In August 2022, TX103 Chimeric Antigen Receptor T-Cell Injection, filed by Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd., received the CDE clinical trial implied permission. It is proposed to be developed for: TX103-positive patients with advanced solid tumors who have failed previous standard treatments or experienced intolerable toxicity, as confirmed by pathology.

On September 30 this year, Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. announced that the IND for TX103 CAR-T cells, developed by the company and its U.S.-based Tcelltech, had been approved by the U.S. FDA for the treatment of malignant glioblastoma.Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd.'s TX103 product has been granted a Chinese invention patent and international patent authorization.

Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. is a clinical-stage innovative biopharmaceutical company focused on developing T-cell immunotherapy products. It was co-founded by Professor Lieping Chen, a pioneer in tumor immunology, and Professor Gangxiong Huang, an expert in immune cell therapy.The company takes research and development innovation as its mission, focusing on developing innovative technologies and drugs for tumor immunotherapy and immune cell therapy. It has built a professional team covering the entire drug development process, including scientific research, technology development, quality management, production processes and registration, and clinical research.Led by Professor Chen Lieping, the Fuzhou Tuoxin Tiancheng Biotechnology Co., Ltd. team is dedicated to developing globally innovative immunotherapy drugs to address unmet medical needs, bringing new hope to more cancer patients.

E.N.D

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