Recently, the bispecific antibody YK012 (acceptance number: CXSL2200041) independently developed by Yikester (Beijing) Pharmaceutical Technology Development Co., Ltd. was officially approved by the Drug Evaluation Center of the State Drug Administration. YK012 is an innovative bispecific antibody targeting CD3/CD19 for the treatment of recurrent/refractory B-cell non-Hodgkin lymphoma.
The approval of IND this time marks the transition from research and development to clinical use of new drugs with bispecific antibody of Yike Si Te, and is an important milestone in the research and development pipeline of Yike Si Te new drugs.
YK012, a bispecific antibody targeted at CD3 and CD19, is a Class I innovative drug, which is developed based on the quality by design concept of innovative immune double antibody design and the FIST platform with unique advantages and characteristics of YK012. It is positioned as the best in class.
The preclinical study data of YK012 of Ekester showed that its safety and effectiveness were significantly better than the marketed product Blincyto: at the cytological level, YK012 differentiated between effector cells and target cells; T cells are crosslinked and activated when and only when target cells exist; The level of full-spectrum CRS cytokines (including IL-6, IL-2, etc.) released by induction was significantly lower than that of Blincyto; The half-life of the monkey is more than 200 hours, more than 100 times that of Blincyto. Compared with Blincyto's continuous intravenous infusion for 24 hours, YK012 will be injected intravenously once every two weeks, greatly improving the convenience and compliance of patients. In addition, Yikester YK012 has achieved the expression yield above gram level, and the preparation process is simple and efficient, laying a good foundation for the follow-up industrialization.
Co-founder of Ecotech CEO Yuan Qing'an said, "Ecotech is committed to developing products with global commercial value and functional superiority. At present, the main obstacle to developing CD3 bispecific antibodies that mobilize T cells to kill tumor cells is the severe cytokine storm (CRS) The clinical safety problems caused. In response to this pain point, Ecotech has designed the FIST platform, which has significantly reduced the CRS level of such products through a variety of ways, and has significantly increased the half-life and yield. It has the characteristics of high efficiency, high yield, low toxicity, and ease of use. It is a new generation of products in the field of CD3 dual antibody.
YK012 is a new targeted drug developed by us for acute leukemia (ALL), non-Hodgkin's lymphoma (NHL) and other B-cell dysplasia diseases, with the same mechanism as CAR-T. The data of preclinical pharmacodynamics model showed that YK012 had better efficacy than Blincyto while greatly improving the safety. It was only two months from the submission of the application to the approval of the product, which proved the adequacy and effectiveness of the pre-clinical research data and laid a solid foundation for the clinical trial. Therefore, for the promotion of YK012 clinical trial, we are full of expectations and actively explore the development of new indications.
Based on the FIST platform, EKST also develops other new products that are urgently needed in clinic‘ In order to be better and different, it is the purpose of developing each variety to be a good medicine that people can afford. We hope to benefit more patients through our efforts. "