FDA Cites Issues at Hengrui Subsidiary, Rejects Camrelizumab

A Form 483 from the FDA revealed various issues that led to the unexpected rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics' PD-1 inhibitor camrelizumab in May. The 10-page document, issued to Suzhou Suncadia Biopharmaceuticals (a Hengrui subsidiary) in December 2023 after a two-week inspection, highlighted several problems. These included inadequate control over equipment systems protecting data integrity, lack of procedures to prevent microbiological contamination of sterile drug products, insufficient visual inspections before product release, failure to implement controls ensuring product standards, and potential mix-ups of raw materials for the Chinese and U.S. markets.

These deficiencies at the Suncadia plant were a primary reason for the FDA's rejection of the monoclonal antibody camrelizumab and the small-molecule VEGFR inhibitor rivoceranib as a combination treatment for newly diagnosed liver cancer. Following the citation, Hengrui submitted a detailed response, which Elevar CEO Saeho Chong, Ph.D., stated satisfied the FDA's drug review team. The FDA advised Hengrui to refile its application, with resubmissions planned for late September or October. However, approval will require clearance from a separate FDA inspection team, possibly including a reinspection of the facility.