IMMUNEONCO-B (01541) announced that the Group has submitted an application for a Phase III clinical trial of IMM0306 to the Center for Drug Evaluation of China's National Medical Products Administration (NMPA).
IMM0306, independently developed by the Group, is a bispecific molecule targeting cluster of differentiation 47 (CD47) and cluster of differentiation 20 (CD20), representing the world's first CD47 and CD20 dual-targeting bispecific molecule to enter clinical stages.
IMM0306 works by inhibiting CD47-SIRPα interactions to block "don't eat me" signals, enhancing Fc-FcɣRIIa and Fc-FcɣRIIIa interactions to activate macrophages and NK cells, and preferentially binding to CD20 rather than CD47. This approach effectively eliminates malignant B cells while minimizing toxicity, thereby improving therapeutic outcomes.
As of the date of this announcement, the Group holds global intellectual property and commercialization rights for IMM0306.