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Immunotech Biopharm Ltd ( (HK:6978) ) has provided an announcement.
Immunotech Biopharm Ltd has disclosed that China’s Center for Drug Evaluation has rejected its conditional new drug application for EAL in preventing postoperative recurrence of liver cancer, citing the need for confirmatory clinical trial data in an immunologically characterized patient group. The regulator noted that, without such data, it cannot complete a full benefit–risk assessment, preventing approval under the conditional pathway.
The company plans to proceed with the required confirmatory clinical study and intends to resubmit EAL for approval under the regular review process once the study is complete. Management emphasized that this decision relates only to the conditional application and does not affect ongoing trials or development of other pipeline assets, limiting operational disruption but delaying potential commercialization of its flagship product in a key liver cancer indication.
More about Immunotech Biopharm Ltd
Immunotech Biopharm Ltd is a leading Chinese biopharmaceutical company specializing in cellular immunotherapy, with a focus on T cell-based treatments for cancers and other major diseases. Founded in 2006, it develops and commercializes a pipeline that includes non-genetically-modified and genetically-modified multi-target and single-target products such as EAL, CAR-T, and TCR-T therapies.
Its core candidate EAL is a multi-target cellular immunotherapy derived from a patient’s own peripheral blood T cells, expanded and activated using patented methods. The product is primarily composed of CD8+ cytotoxic T cells, and has been used clinically for over a decade in treating various types of cancer in China, underscoring its central role in the company’s strategic portfolio.
Average Trading Volume: 377,594
Technical Sentiment Signal: Sell
Current Market Cap: HK$1.82B
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