HanX Biopharmaceuticals is gearing up to begin a Phase I/II trial in relapsed/refractory lymphoma after gaining a regulatory nod from the US Food and Drug Administration (FDA).

The planned Phase I/II trial of HX-009 will mark the first US-based study of HanX’s antibody. The Wuhan-China based biotech has previously studied the drug in China and Australia.

HX-009 is a bispecific antibody targeting both integrin-associated protein CD47 and programmed cell death protein 1 (PD-1). While trials testing checkpoint inhibitors targeting PD-1 have been gaining steam, there is still significant unmet patient need in the oncology space. Meanwhile, pharma is also moving to develop chimeric antigen receptor T- cell (CAR-T) therapies for lymphoma.

Drug development in the US and China

The planned Phase I/II trial of HX-009 will expand the global footprint of HanX as it pursues clinical development in the US. This follows a trend of more domestic Chinese companies developing checkpoint inhibitors, potentially diminishing revenue for Western pharma companies.

Meanwhile, China is rapidly becoming a major player in the global pharmaceutical market, with development programs ranging from CAR-T cell therapies to small molecules for rare diseases. In 2022, China accounted for 27.7% of global clinical trial activity—representing a sharp uptick from its previous 10-year average, according to GlobalData.