The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered as a first-line therapy for irresectable or metastatic hepatocellular carcinoma (HCC).
The FDA’s decision is not related to the clinical data but is attributed to issues identified at the manufacturing site. The agency will undertake a comprehensive evaluation based on Hengrui’s response to the production site inspection deficiencies. The FDA’s letter also noted that due to travel restrictions in certain countries, not all necessary biological research monitoring plan (BIMO) clinical examinations for the project could be completed within the review cycle. Hengrui intends to maintain active communication with the FDA and plans to refile the application soon.
Camrelizumab was first approved in China in May 2019 for use as a third-line treatment for classic Hodgkin’s lymphoma and has since gained nine indication approvals in China, covering a range of cancers including lung, liver, esophageal, nasopharyngeal, and lymphoma. Eight of these indications have been included in the National Reimbursement Drug List (NRDL).- Flcube.com
