Hengrui faces FDA setback on camrelizumab, gains approval elsewhere

Jiangsu Hengrui Medicine (SSE:600276) is navigating a mixed regulatory landscape, according to recent announcements. The company received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) concerning its Biologics License Application for camrelizumab injection in combination with apatinib for unresectable or metastatic hepatocellular carcinoma (liver cancer). The FDA's letter indicated the need for further responses regarding manufacturing site inspections, but did not specify the reasons for the rejection. Hengrui plans to engage with the FDA to address the concerns and resubmit its application.