China’s Hengrui Pharmaceuticals has announced a third postponement in gaining U.S. approval for its liver cancer treatment, citing the need to address improvements at its American partner’s manufacturing facility. The facility was inspected by the Food and Drug Administration in April, and steps are being taken to implement the recommended modifications, according to the company based in Jiangsu Province. The plant had successfully passed an inspection by the European Union last year.
Hengrui Pharmaceuticals collaborated with Elevar Therapeutics to develop a PD-1 targeted therapy for liver cancer. The treatment combines Hengrui’s PD-1 inhibitor, Camrelizumab, with Rivoceranib from Elevar Therapeutics. Clinical trial results indicated that patients receiving the combined therapy had a median overall survival of 23.8 months. The treatment was approved for market launch by China’s National Medical Products Administration in January 2023.
The company emphasized that the FDA’s feedback did not relate to the safety, efficacy, or clinical data of the drug. It stated that ongoing communication with the FDA and its U.S. partner will help clarify the next steps. Previously, the FDA delayed approval twice—initially in May 2024 and then again in March 2025—primarily due to manufacturing concerns.
Today, shares of Hengrui Pharmaceuticals edged up 0.3% in Shanghai, closing at 55.75 yuan (about $8.22 USD), while its Hong Kong-listed stock gained 1.3%, finishing at HKD 59.25 (approximately $7.56 USD).