IMMUNEONCO-B (01541) rose nearly 4%, reaching HK$6.23 by the time of writing, with a trading volume of HK$3.12 million. The company announced on December 18 that the Investigational New Drug (IND) application for its self-developed bispecific antibody-recombinant protein drug Amurelifusp-α (subcutaneous injection formulation, IMM0306S), targeting both CD47 and CD20 for the treatment of systemic lupus erythematosus (SLE), has been officially accepted by China's National Medical Products Administration (NMPA). This marks a significant milestone in the company's innovative drug development for autoimmune diseases.

IMM0306S is a subcutaneous formulation derived from IMMUNEONCO-B's core product, Amurelifusp-α (IMM0306). Amurelifusp-α (CD47xCD20, IMM0306) is the world's first CD47xCD20 bispecific molecule to enter clinical development, based on the company's proprietary "mAb-Trap" technology platform. The company has established a comprehensive development strategy for this product.

Notably, at the 67th American Society of Hematology (ASH) Annual Meeting, IMMUNEONCO-B presented Phase I/II clinical data for Amurelifusp-α (IMM0306) combined with lenalidomide in treating relapsed/refractory CD20-positive follicular lymphoma (R/R FL). The data showed an objective response rate (ORR) of 91.2% and a complete response rate (CR) of 67.6% in patients who had previously failed at least one line of anti-CD20 monoclonal antibody therapy. The combination demonstrated manageable safety with no risk of cytokine release syndrome. The ongoing Phase I/II study offers a promising new immunotherapy strategy for this currently incurable disease with limited treatment options post-relapse.