Hengrui Pharma Receives Regulatory Clearance for Clinical Trial of Irinotecan Liposome Injection

Stock News03-13 17:54

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (600276.SH) has announced that its subsidiary, Shanghai Hengrui Pharmaceutical Co., Ltd., recently obtained a drug clinical trial approval notice from the National Medical Products Administration for Irinotecan Hydrochloride Liposome Injection (II), with clinical trials to commence in the near future. According to the Drug Administration Law of the People's Republic of China and related regulations, the clinical trial application for Irinotecan Hydrochloride Liposome Injection (II), submitted on December 25, 2025, was reviewed and found to meet the requirements for drug registration, granting approval to proceed with the trial. The trial is specifically designed as a randomized, open-label, parallel-controlled, multicenter Phase III clinical study. It will compare HR070803 in combination with oxaliplatin, 5-fluorouracil, and calcium folinate versus gemcitabine combined with capecitabine for postoperative adjuvant treatment of pancreatic cancer.

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