On January 29, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") announced that the phase Ib/IIa clinical study of the company's self-developed bispecific antibody-receptor recombination targeting both CD47 and CD20 protein drug (Project No.: IMM0306), combined with lenalidomide in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) was approved by the National Medical Products Administration (NMPA) License, this is another new breakthrough of ImmuneOnco in the combination of innovative antibody drugs for the treatment of refractory tumors.  

Previously, IMM0306 has been approved by China’s NMPA and the U.S. FDA to carry out clinical trials, and has obtained patent authorizations in China, the U.S. and Japan, which consolidates ImmuneOnco’s leading position in the development of CD47-targeted drugs and bispecific antibody research.

Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, said,

"I am very pleased to see that our Phase Ib/IIa clinical study of IMM0306 combined with lenalidomide (Len) in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma has been approved by the NMPA. IMM0306 is a drug that simultaneously targets CD47. The antibody-receptor recombinant protein (mAb-Trap) of CD20 and CD20 is the world's first CD47xCD20 dual-target specific molecule that has entered the clinical trial stage. IMM0306 does not bind to human red blood cells in vitro, and preclinical in vivo efficacy tests have shown that its drug effect is significantly better than that of rituximab. The preliminary data of Phase I clinical trials show that the single drug has good safety and good clinical efficacy response, especially in relapsed and refractory follicular lymphoma. Encouraging tumor remission efficacy. The IMM0306 approved today combined with Len has shown a good synergy in the preclinical pharmacodynamic model (below). Therefore, in our development strategy, we will enter the front-line from the indolent lymphoma in the back-line indications, and will be further expanded to more aggressive diffuse large B lymphoma (DLBCL), which is expected to benefit more lymphoma patients."