CSPC PHARMA (01093) announced that the new indication for its Irinotecan Hydrochloride Liposome Injection (brand name: Doxenat®) has received marketing approval from China's National Medical Products Administration. The newly approved indication is for first-line treatment of metastatic pancreatic cancer in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV).

The approval was primarily based on a key clinical trial involving patients with unresectable locally advanced or metastatic pancreatic cancer confirmed by histology or cytology, who had not previously received systemic anti-tumor therapy. Results presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated that the product significantly prolonged progression-free survival (PFS) (hazard ratio [HR] 0.55, representing a 45% reduction in disease progression or death risk). It also showed favorable trends in objective response rate (ORR), duration of response (DOR), and overall survival (OS), with improved safety and efficacy compared to conventional formulations.

Doxenat® was first approved in China on September 15, 2023, for treating metastatic pancreatic cancer patients who progressed after gemcitabine therapy, in combination with 5-FU and LV. It was the first domestically developed Irinotecan Hydrochloride Liposome Injection approved in China. The newly approved indication marks the product’s second approval in China and the first time an irinotecan liposome injection has been approved for first-line pancreatic cancer treatment domestically.

Currently, a pivotal Phase III registration trial is underway to evaluate the product’s use in adjuvant therapy for post-operative pancreatic cancer patients.