Immunotech Biopharm's EAL drug application accepted in China
Immunotech Biopharm announced that its conditional new drug application (NDA) for EAL®, the company's core product candidate, has been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This follows the earlier communication with the CDE in February, where the CDE agreed Immunotech may submit an application for conditional approval for EAL®, and the granting of priority review in March. EAL® is described as a multi-target cellular immunotherapy product with a clinical track record of over a decade in treating various cancers. It utilizes activated and expanded T cells derived from a patient's autologous peripheral blood, cultured using patented methods, with CD8+ cytotoxic T cells as the primary active component. Immunotech's broader pipeline includes CAR-T cell and TCR-T cell series products. The company has a manufacturing center in Beijing and is planning R&D and production centers in other densely populated areas of China to facilitate clinical trials and future commercialization.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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