(Yicai) July 10 -- China’s Hengrui Pharmaceuticals has announced a third delay in US approval for its liver cancer therapy, due to the need for improvements at its American partner’s drug production site.

The plant was inspected by the US Food and Drug Administration in April, and improvement measures are being taken based on the regulator’s feedback, the Jiangsu province-based company said today. It had passed a European Union inspection last year.

Hengrui Pharma partnered with Elevar Therapeutics to launch a PD-1 drug therapy for liver cancer. The therapy combines Hengrui Pharma’s PD-1 inhibitor Camrelizumab‌ and Rivoceranib from Elevar Therapeutics.

Clinical research results from Hengrui Pharma showed that the median overall survival rate of the treatment group using the PD-1 combined therapy reached 23.8 months. The therapy received market approval from China’s National Medical Products Administration in January 2023.

The company clarified that the FDA’s feedback did not involve any issues regarding the clinical research data, safety, or efficacy of the drug. Hengrui Pharma will communicate closely with the FDA and its US partner to clarify future plans, it said.

The FDA’s previous delays to approving the drug -- first in May 2024 and then in March 2025 -- also related to manufacturing issues.

Shares of Hengrui Pharma [SHA: 600276] closed 0.3 percent higher at CNY55.75 (USD8.22) each in Shanghai today, while its Hong Kong-listed stock [HKG: 1276] climbed 1.3 percent to finish at HKD59.25 (USD7.56).

Editor: Tom Litting