On July 17, 2023, the CD19-targeted chimeric antigen receptor-engineered NK cell drug product developed by Simnova Biotechnology was officially approved for registered clinical trial by the Center for Drug Evaluation (CDE) of the State Drug Administration, indicating that the first universal NK cell therapy product of this target in China will officially enter the first phase of clinical research. In addition to the currently approved indications, this product will also have IND declarations for other indications.

    In the process of product development, Simnova Biotechnology has adopted an innovative CAR structure design with intellectual property rights. In preclinical studies, it has demonstrated more potent anti-tumor effect than similar CAR designs. At the same time, Simnova Biotechnology has the mature and stable CMC capability to produce large-scale universal NK cell products. The CAR transduction efficiency of NK cells, expansion rate, and cell activity after cryopreservation and recovery have all reached industry-leading levels. Subsequent similar universal projects will use this mature NK platform. It is expected that such universal products can benefit more cancer patients through good safety, efficacy and accessibility. In the previous IIT clinical study, the patient with the longest benefit had achieved complete remission for more than 1 year, which was significantly longer than the duration of remission obtained by the same patient who received autologous CART therapy before.

      Simnova Biotechnology was founded in 2019, which as a subsidiary of Simcere Pharmaceuticals, then spun off into an independent operating company in 2021. There are research centers in Shanghai, China and Boston, USA. In addition to focusing on the development of CAR-NK and next-generation mRNA in vivo cell therapy products with global competitiveness, the company is also actively promoting the clinical research and application of solid tumor CAR-T projects, striving to bring effective, safe and accessible innovative cell therapy drugs to patients with hematological and solid tumors as soon as possible.