On July 4, 2023, the recombinant anti human IL-4Ra and IL-5 double antibody injection (RC1416 injection) independently developed by Nanjing Rongjiekang Biotechnology Co., Ltd. was administered to the first subject in China-Japan Friendship Hospital, marking that Nanjing Rongjiekang antibody drug development entered the clinical research stage. The purpose of this study is to evaluate the safety and tolerability in healthy Chinese subjects.

RC1416 is the first bispecific antibody drug developed by Nanjing Rongjiekang based on nanoantibody technology. By blocking the IL-4, IL-5, and IL-13 signaling pathways, it can be used for the treatment of Th2 type immune cell pathway overactivation related diseases. During the research and development process, the Nanjing Rongjiekang R&D team conducted step by step antibody screening, combination, evaluation, and re screening through the drug development process of camel immunity, antibody screening, antibody modification, and antibody combination, ultimately obtaining anti IL-4R/IL-5 bispecific antibodies with excellent performance in multiple indicators such as efficacy, safety, and drug formation.

Studies on the pathological and physiological mechanisms of IL-5 and IL-4R targeted asthma and the clinical treatment of Th2 cell targeted drugs have shown that in the treatment process of asthma patients, simultaneous action on two or more targeted drugs may achieve better therapeutic effects compared to single targeted drugs. Therefore, the Rongjiekang team designed bispecific antibodies that simultaneously target IL-4R and IL-5 to downregulate signals induced by IL-4, IL-5, and IL-13. IL-4R α The dual target of IL-5 is an international initiative and belongs to Class 1 innovative drugs.

RC1416 was approved for clinical trial by the National Drug Administration (NMPA) of China on March 27, 2023, and was approved for clinical trial by the US Food and Drug Administration (FDA) on April 7. Nanjing Rongjiekang is gradually practicing clinical demand and market-oriented technological innovation, and continues to firmly move forward on the path of "maintaining human health with excellent drugs".