Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment

Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy.

HX009’s Clinical Trials in Australia and China
HX009 has already entered trials in Australia and China, focusing on both solid tumor and lymphoma indications. The bispecific antibody targets CD47 and PD-L1, which are key innate and adaptive immune checkpoints that coordinate the suppression of the immune system in relation to tumor cells. By dual-targeting both checkpoints, HX009 increases cytosolic DNA sensing in dendritic cells (DCs), thereby generating anti-tumor T cell responses.

Competition in the CD47/PD-1 BsAb Space
Other companies are also developing CD47/PD-1 BsAbs, including Innovent Biologics Inc. (HKG: 1801), ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd, (HKG: 1541) and Bio-Thera Solutions Ltd (SHA: 688177). This competitive landscape indicates the significant interest in advancing immunotherapies that can effectively target multiple immune checkpoints to enhance anti-tumor responses.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry