SUZHOU, January 23, 2024/PRNewswire/ -- On January 17, 2024, a non-genetically-modified natural killer cell injection (project code NK010) independently developed by Shanghai Enkai Cell Technology Co., Ltd. (“NK010”) obtained approval from the US Food and Drug Administration (FDA) for phase I clinical trials (IND). Currently, this product is the first non-genetically modified allogenetically modified peripheral blood NK cell drug approved by the FDA in China. Boteng Biotech warmly congratulates them on this.
NK010 has high anti-cancer advantages such as optimized receptor spectrum, diverse targets, high purity, and universality, making it potentially capable of treating many types of tumors. NK010 also has potential for expansion into treatment of non-neoplastic diseases, and is the best base cell for a subsequent series of synthetic NK cell drugs (SynNK). Ovarian cancer indications are preferred in phase I clinical trials. Preclinical studies have shown that NK010 cell injections have shown strong anti-tumor activity in solid tumors such as ovarian cancer and liver cancer, as well as animal models such as acute myeloid leukemia.
As a partner of Enkai Pharmaceuticals, Boteng Biotech provided support services for product preparation and related registration data for the project, and fully supported the NK010 project to be approved by the US FDA IND. It is worth mentioning that the NK010 project is the first NK cell therapy formulation project in which Boteng Biotech participated.
According to Professor Tian Zhigang, a double academician of the Chinese Academy of Engineering and the European Academy of Sciences, and founder of Enkai Pharmaceuticals, “I am sincerely happy and proud that the NK010 project has received clinical trial approval. At the same time, there are still many things to explore, and the team has begun to conduct more and more in-depth research on the next phase of the project to meet urgent clinical needs. Enkai Pharmaceutical adheres to the innovative route of independent research and development. In the field of NK cells, we are also advancing several product pipelines, hoping to bring more novel therapies to patients around the world.”
Dr. Wang Yangzhou, CEO of Boteng Biotech, said, “Congratulations on receiving FDA IND approval for the NK010 injection NK cell therapy product. We are honored to support this project. The indications for NK010 to treat solid tumors have been approved by the US FDA, which is a recognition of the innovative strength and international development of Enkai Pharmaceuticals. We sincerely hope that subsequent clinical trials of the NK010 product will proceed smoothly, and we look forward to continued in-depth cooperation with NK010 in the future to enable more R&D pipelines to make new progress and achieve breakthroughs in NK cell therapy products in the field of solid tumors and hematoma.”
About Enkai Pharmaceuticals
Shanghai Enkai Cell Technology Co., Ltd. (Enkai Pharmaceuticals) is a biotechnology company focusing on the development of innovative immunocyte therapy technologies. Based on the team's more than 30 years of exploratory research on basic biology, preclinical, and clinical translational research on NK cells, Enksai is committed to becoming the world's leading cell therapy company with a deep understanding of NK cell therapy and cutting-edge technology. Enkai Pharmaceuticals has unique allogeneic peripheral blood NK cell amplification and cryopreservation, genetic modification, and clinical “off-the-shelf” grade ABCDE-NKAn industrial production platform (NK cell production can reach the trillion level of NK cells in a single blood supply), and uses synthetic immunological chassis technology such as logic gate gene circuits to achieve intelligent editing of NK cells, so that they can accurately target cancer cells, accurately adapt to the tumor microenvironment, and accurately match donors' effects/target cells. Guided by solving major clinical disease treatment problems and achieving accurate immunotherapy, Enkai Pharmaceuticals will develop a series of original intelligent NK cell products, strive to continuously break through core technology and continue to be the world's leading immune cell drug company, and become a global source of next-generation NK cell therapy technology and products. Enkai Pharmaceutical has completed Series A financing, led by Huagai Capital. Shareholders include well-known investment institutions such as Chinese Academy of Sciences Venture Capital, Qiandao Fund, Chengyi Capital, Sirius Capital, and Qiao Jing Capital. Currently, the company is actively opening up external cooperation and financing to promote clinical trials of core products and the development of more new products.
About Boteng Biotech
Suzhou Boteng Biopharmaceutical Co., Ltd. was founded in December 2018, based in Suzhou Industrial Park, based on the listed company - Chongqing Boteng Pharmaceutical Technology Co., Ltd. (stock code: 300363) to build CRO and CDMO platforms such as plasmids, viral vectors, cell therapy, gene therapy, nucleic acid therapy, etc., to provide end-to-end services from scientific research and packaging, process development, analytical method development, cGMP production to formulation filling, throughout different stages of drug development and marketing.
Boten Biotech focuses on gene and cell therapy. On top of the successful experience of Boten Co., Ltd., with world-class professionals as the core, adhering to the “customer first” service purpose, “compliance, professionalism, focus and open collaboration” as the brand concept, continuing the parent company's strong IP protection and project management mechanism and perfect quality management system, making full use of the core team's successful experience in promoting gene and cell therapy products from clinical to marketing, providing high-quality and efficient services to customers around the world, so that good drugs can benefit the public sooner.