The board (the “Board”) of directors (“Directors”, and each a “Director”) of the Company is pleased to announce that the Group has received approval from the National Medical Products Administration of the People’s Republic of China (the “NMPA”) for a clinical trial of IMM01 (Timdarpacept) in combination with IMM2510 (palverafusp α) and with or without chemotherapy, for the treatment of advanced malignant tumors. This significant progress marks another key step in the Company’s rapid advancement of clinical research of IMM01 (Timdarpacept) and IMM2510 (palverafusp α).

ABOUT IMM01 (TIMDARPACEPT) 

IMM01 (Timdarpacept), the Group’s core product, is an innovative molecule targeting CD47. It is the first SIRPα-Fc fusion protein to enter into clinical stage in China. IMM01 (Timdarpacept) designed with immunoglobulin G1 (IgG1) Fc can fully activate macrophages via a dual mechanism — simultaneously blocking the “don’t eat me” signal by disrupting CD47/SIRPα interaction and delivering the “eat me” signal through the engagement of activating Fc-gamma (Fcγ) receptors on macrophages. Furthermore, the CD47-binding domain of IMM01 (Timdarpacept) was specifically engineered to avoid human red blood cell (RBC) binding. With the differentiated molecule design, IMM01 (Timdarpacept) has achieved a favorable safety profile and demonstrated its ability to activate macrophages. IMM01 (Timdarpacept) in combination with azacitidine was granted orphan-drug designation by the Food and Drug Administration of the United States (FDA) for the first-line treatment of CMML in November 2023. The Group owns the global intellectual property rights and commercial rights of IMM01 (Timdarpacept). As of the date of this announcement, in relation to IMM01 (Timdarpacept), the Group owned one patent family, which includes issued patents in China, the United States, Japan and the European Union. 

ABOUT IMM2510 (PALVERAFUSP α) 

IMM2510 (palverafusp α), independently developed by the Group, is a bispecific molecule with a mAb-Trap structure targeting vascular endothelial growth factor (VEGF) and programmed cell death ligand 1 (PD-L1). IMM2510 (palverafusp α) can inhibit angiogenesis, leading to tumor shrinkage, and sensitize tumor cells to immune responses, while activating T cells, NK cells, and macrophages via the blockade of PD-L1/programmed cell death protein 1 (PD-1) interaction and the induction of Fc-mediated antibody-dependent cellular cytotoxicity (ADCC)/antibody-dependent cellular phagocytosis (ADCP) activity. The Company and Axion Bio, Inc. (formerly known as SynBioTx Inc.), a wholly-owned subsidiary of Instil Bio, Inc. (NASDAQ: TIL), have entered into a license and collaboration agreement, pursuant to which the Company owns the commercial rights of IMM2510 (palverafusp α) in the Greater China region, including mainland China, Hong Kong Special Administrative Region of China, Macau Special Administrative Region of China and Taiwan (the “Greater China Region”) and agreed to grant Axion Bio, Inc. an exclusive license to research, develop and commercialize IMM2510 (palverafusp α), outside the Greater China region.