Hengyu Bio Congratulates BinTie Bio on NMPA's IND Approval for IX001 TCR-T Injection

Oct 09, 2024 20:43 CST Updated 20:43

Immuxell Biotech

Developer of Immune Cell Therapeutic Drugs

On October 9, 2024, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed,ImmuXell Biotech LtD.(hereinafter referred to as "ImmuXell Biotech")）TCR-T Cell Therapy Product "IX001 TCR-T Injection"(Application Nos.: CXSL2400445, CXSL2400446) have officially received the clinical trial implied permission from the National Medical Products Administration (NMPA), approving the initiation of clinical trials.

Hengyu BioProvided in this project are materials compliant with Chinese filing requirements.Cell Line Characterization (CLC) and Mycoplasma TestingSuch biosafety testing services, with internationally compliant quality and technical systems, rapid delivery, and professional project management, safeguard the overseas launch of innovative drugs.

About IX001 TCR-T

IX001 TCR-T Injection is a cell therapy product independently developed by ImmuXell Biotech with independent intellectual property rights. It is being developed to treat advanced pancreatic cancer in patients with the HLA-A*11:01 genotype and positive expression of the tumor antigen KRAS G12V. Pancreatic cancer (commonly known as the "King of Cancers") has long been a global medical challenge due to its low early diagnosis rate, high recurrence rate, and resistance to chemotherapy. Each year, there are over 200,000 newly diagnosed cases of pancreatic cancer worldwide, with nearly the same number of patients dying due to the lack of effective treatments. KRAS gene mutations (including G12D, G12V, and G12C), the most common oncogenic mutations in pancreatic cancer, represent an ideal target for new drug development. On August 2, 2024, the world's first TCR-T therapy targeting solid tumors, afamitresgene autoleucel (afami-cel), was approved by the U.S. FDA for the treatment of patients with the HLA-A*2 genotype expressing MAGE-A4 in advanced synovial sarcoma, paving the way for the successful commercialization of TCR-T therapies.

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ImmuXell Biotech WeChat Official Account

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According to incomplete statistics, ImmuXell Biotech has successfully contributed to nearly60Project AcquisitionClinical and MarketTest Batch (including recent30China-US dual filing projects), with a comprehensive coverage of申报项目 categories (antibody/recombinant protein, gene therapy, cell therapy, RCL, rcAAV).

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About ImmuXell Biotech

ImmuXell Biotech, founded in 2021, is an innovative biopharmaceutical company focused on the research and clinical translation of T-cell receptor (TCR) therapeutics for solid tumors (TCR-T). ImmuXell Biotech has an efficient R&D and clinical translation team capable of rapidly and effectively transforming fundamental laboratory discoveries into clinical applications. The company owns multiple technology platforms and a robust product pipeline. Its leading product targets pancreatic cancer with KRAS mutations using immune effector cells genetically modified with T-cell receptor genes, which has already achieved breakthrough preliminary results in IIT clinical studies.

About ImmuXell Biotech

HengYuBiologicalRelying on international compliance standards and leveraging exceptional quality and technical expertise, ImmuXell Biotech has established a one-stop Biosafety service platform specializing in large molecule drugs and CGT drugs. It has passed audits and certifications such as EU QP, CNAS, and ISO9001, meeting the stringent requirements of global regulatory agencies including NMPA, FDA, and EMA, providing reliable support for innovative pharmaceutical companies. ImmuXell Biotech has served over 200 biopharmaceutical companies, with extensive experience in projects and regulatory submissions. It has provided critical support for more than 50 clinical and market application cases of biologics, offering services such as viral clearance validation, cell bank characterization, commercial batch release, detection of replication-competent viruses (RCL, rcAAV, RCR, etc.), and HCD and HCP kit testing.

ImmuXell Biotech has a highly experienced technical and quality team, utilizing advanced systems and management frameworks, including LIMS and EMS systems that comply with ISPE GAMP5 management requirements, and has established a data management system following the ALCOA+ principles. Whether for IND or BLA submissions of biologics or full lifecycle management of commercial production, ImmuXell provides reliable biosafety and quality control support, ensuring strong backing for our clients' success.