NK CellTech Obtains FDA Clearance for NK010 Clinical Trial

NK CellTech Co., Ltd. (NK CellTech), a leading biotechnology company specializing in the development of NK cellular therapies, is excited to announce that the FDA has granted clearance for the clinical trial of NK010, a groundbreaking non-genetically modified natural killer cell therapy. NK010 marks the first instance of FDA approval for a clinical trial involving non-genetically modified NK cells derived from allogeneic peripheral blood cells (PBMC) originating from China.

Distinguished by its numerous high anti-tumor advantages, including a broad spectrum and elevated expression of NK cell activation receptors, as well as remarkable purity, NK010 offers the potential to address a diverse array of tumor types. Moreover, its versatility extends to the treatment of non-tumor diseases, positioning it as an ideal foundational cell for subsequent synthetic NK cell drugs (SynNK) in the company's development pipeline. Ovarian cancer has been selected as the primary indication for exploration in this Phase I clinical trial, backed by pre-clinical studies that highlight NK010's exceptional potential in inhibiting tumor growth across various cancers such as ovarian, liver, and other solid tumors, as well as acute myeloid leukemia.

Expressing enthusiasm, Professor Zhigang Tian, the Founder of NK CellTech and a member of the Chinese Academy of Engineering and the Academia Europaea, stated, "We are thrilled and proud to receive FDA clearance for the clinical trial of NK010. NK010 has demonstrated promising anti-tumor activity and safety in preclinical studies. We have great confidence in its potential to treat solid tumors. Yet, there is still much left to explore, and our team remains committed to our mission of revolutionizing cancer treatment through innovative cellular therapies and addressing unmet clinical needs in the future.

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