SHANGHAI, Jan. 22, 2024 /PRNewswire/ -- On January 17, 2024, NK CellTech Co., Ltd. (NK CellTech), a leading biotech company focused on the development of NK cellular therapies, is pleased to announce that the FDA has granted clearance for the clinical trial of NK010, the non-genetically modified natural killer cells.

上海，2024年1月22日/PRNewswire/--2024年1月17日，专注于NK细胞疗法开发的领先生物技术公司NK CellTech Co.，Ltd.（NK CellTech）高兴地宣布，FDA已批准NK010（一种非转基因自然杀伤细胞）的临床试验。

NK010 is the first non-genetically modified NK cells expended from allogeneic peripheral blood cell (PBMC) approved for clinical trial by the FDA from China..

NK010是由中国FDA批准用于临床试验的同种异体外周血细胞（PBMC）消耗的第一个非转基因NK细胞。。

NK010 exhibits multiple high anti-tumor advantages including wide spectrum and high expression of NK cell activation receptors and high purity, which makes it possible to treat variety types of tumors. NK010 also shows the potential to treat non-tumor diseases and can be the best basal cell for a subsequent series of synthetic NK cell drugs (SynNK) developed by the company.

NK010具有多种高抗肿瘤优势，包括NK细胞活化受体的广谱和高表达以及高纯度，这使得治疗各种类型的肿瘤成为可能。NK010还显示出治疗非肿瘤疾病的潜力，可能是该公司随后开发的一系列合成NK细胞药物（SYNK）的最佳基础细胞。

The ovarian cancer was the first indication chosen for exploration in this Phase I clinical trial. Pre-clinical studies have shown outstanding potential, with NK010 exhibiting strong tumor growth inhibition on ovarian cancers in animal models, liver cancer and other solid tumors as well as acute myeloid leukemia..

卵巢癌是该I期临床试验中首次选择用于探索的适应症。临床前研究显示出巨大的潜力，NK010在动物模型，肝癌和其他实体瘤以及急性髓细胞白血病中对卵巢癌表现出强烈的肿瘤生长抑制作用。。

'We are thrilled and proud to receive FDA clearance for the clinical trial of NK010,' said Professor Zhigang Tian, Founder of NK CellTech and member of the Chinse Academy of Engineering and the Academia Europaea. 'NK010 has demonstrated promising anti-tumor activity and safety in preclinical studies.

NK CellTech创始人、中国工程院（Chinese Academy of Engineering）和欧洲研究院（Academy Europaea）成员田志刚（Zhigang Tian）教授说，我们很高兴也很自豪地获得FDA批准进行NK010的临床试验NK010在临床前研究中显示出有希望的抗肿瘤活性和安全性。

We have great confidence in its potential to treat solid tumors. Yet, there is still a lot left to explore, and our team has remained on our mission to revolutionize cancer treatment through innovative cellular therapies and fulfill the unmet clinical needs in the future.'.

我们对其治疗实体瘤的潜力充满信心。然而，还有很多需要探索，我们的团队仍然坚持我们的使命，通过创新的细胞疗法彻底改变癌症治疗，并满足未来未满足的临床需求。”。

About NK CellTech Co., Ltd. (NK CellTech)

关于NK CellTech Co.，Ltd.（NK CellTech）

NK CellTech Co., Ltd. (NK CellTech) is a leading biotech company dedicated to the discovery and development of innovative technology of NK cell therapy. The R&D team has over 30 years of experiences in the research and clinical practice of NK cells, which dedicates NK CellTech to become an international leading company in cellular immunotherapy..

NK CellTech Co.，Ltd.（NK CellTech）是一家领先的生物技术公司，致力于发现和开发NK细胞疗法的创新技术。研发团队在NK细胞的研究和临床实践方面拥有30多年的经验，致力于使NK CellTech成为细胞免疫治疗领域的国际领先公司。。

NK CellTech has a unique ABCDE-NK® industrial production platform featuring our unique technologies of feeder-free large scale expansion and high efficiency gene modification of PBMC-NK cells, cryopreservation provide 'off-the-shelf' supply for clinical immediate use. Through the synthetic immunological technology platform (SynNK) such as the logic gates, NK CellTech has fulfilled the intelligent editing of NK cells so that they are precisely targeted to tumor cells, precisely adopted to tumor microenvironment, and precisely matched between the donor and recipient.

NK CellTech拥有独特的ABCDE-NK®工业生产平台，采用我们独特的无饲养层大规模扩增和PBMC-NK细胞高效基因修饰技术，冷冻保存为临床即时使用提供“现成”供应。通过逻辑门等合成免疫技术平台（SynNK），NK细胞技术实现了NK细胞的智能编辑，使其精确靶向肿瘤细胞，精确适应肿瘤微环境，并在供体和受体之间精确匹配。

NK CellTech has successfully developed a series of innovative intelligent NK cell pipeline products, and remains steadfast in its mission to revolutionize cancer treatment through precision cellular therapies and fulfill the unmet clinical needs..

NK CellTech成功开发了一系列创新的智能NK细胞管道产品，并坚定地致力于通过精确细胞疗法彻底改变癌症治疗并满足未满足的临床需求。。

Forward-looking statement：

前瞻性声明：

This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of terminology such as 'will,' 'may,' 'expects,' 'anticipates,' 'believes,' 'potential,' 'plan,' 'goal,' 'estimate,' 'likely,' 'should,' 'confident,' and 'intends,' (collectively referred to as 'forward-looking statements') and describe opinions about possible future events.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。前瞻性陈述可以通过使用诸如“意愿”、“可能”、“预期”、“预期”、“相信”、“潜力”、“计划”、“目标”、“估计”、“可能”、“应该”、“自信”和“打算”等术语来识别（统称为“前瞻性陈述”），并描述对未来可能发生的事件的看法。

These statements are subject to significant risks and uncertainties. The reader is cautioned not to rely on these forward-looking statements, for they are based on management's current expectations and beliefs of future events as of this date. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors which are beyond the Company's control and which may cause the actual results, performance or achievements of the Company to be materially different from those expressed or forecast in the forward-looking statements.

这些报表存在重大风险和不确定性。提醒读者不要依赖这些前瞻性陈述，因为它们是基于管理层目前对截至目前的未来事件的期望和信念。这些报表不保证未来的业绩，并受到公司无法控制的风险、不确定性和其他因素的影响，这些因素可能导致公司的实际业绩、业绩或成就与前瞻性报表中表达或预测的结果、业绩或成就存在重大差异。

Factors that could cause actual results to be materially different from those reflected in the forward-looking statements include but are not limited to (i) risks associated with our business or market competition; (ii) effects of changes in politics, economies, laws, regulations or policies..

可能导致实际结果与前瞻性报表中反映的结果存在重大差异的因素包括但不限于（i）与我们的业务或市场竞争相关的风险；（ii）政治、经济、法律、法规或政策变化的影响。。

Therefore, neither the Company nor any employee shall assume obligation to update these forward-looking statements, or undertake any obligation if actual results differ materially from those anticipated in the forward-looking statements.

因此，本公司或任何员工均无义务更新这些前瞻性声明，如果实际结果与前瞻性声明中的预期结果存在重大差异，则不承担任何义务。

SOURCE NK CellTech

SOURCE NK CellTech