Hanx Biopharmaceuticals' HX009 Receives NMPA Clearance for TNBC Study

Hanx Biopharmaceuticals’ HX009 Receives NMPA Clearance for TNBC Study

Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clearance from the National Medical Products Administration (NMPA) for its HX009, a bifunctional macromolecule targeting PD-1 and CD47. The company plans to test the investigational cancer immunotherapy in combination with an antibody drug conjugate (ADC) for triple-negative breast cancer (TNBC) in a Phase II study.

Drug Profile
HX009 has completed two Phase I single-dose escalation studies in Australia and China. The drug received approval for study in recurrent/refractory lymphoma in the US in May 2023. The upcoming Phase II trial will evaluate its efficacy and safety in TNBC patients.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry