CSPC Pharma (01093): New indication for Donepezil Hydrochloride Liposome Injection approved for marketing.

CSPC PHARMA (01093) announced that the new indication of Lipososomal Irinotecan Hydrochloride for Injection (trade name: Dongyi) developed by the group has been approved for marketing by the National Medical Products Administration of the People's Republic of China. The newly approved indication is for the first-line treatment of metastatic pancreatic cancer in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV). The approval of this indication is mainly based on a key clinical trial, with patients who have not received systemic anti-tumor treatment and have been histologically or cytologically diagnosed with unresectable locally advanced or metastatic pancreatic cancer being included in the study. Results disclosed at the 2024 American Society of Clinical Oncology (ASCO) annual meeting show that this product for first-line treatment of advanced pancreatic cancer significantly prolongs progression-free survival (PFS) (hazard ratio (HR) of 0.55, 45% reduction in risk of disease progression or death), shows a trend of benefit in objective response rate (ORR), duration of response (DOR), and overall survival (OS), and has good safety profile, achieving both reduced toxicity and enhanced efficacy compared to conventional formulations. The product was first approved for marketing in China on September 15, 2023, with the initial indication being in combination with 5-FU and LV for metastatic pancreatic cancer patients progressing after gemcitabine treatment, making it the first liposomal irinotecan hydrochloride for injection approved for marketing by a domestic company in China. The newly approved indication is the second indication for this product in China and marks the first approval for the use of liposomal irinotecan hydrochloride for injection in first-line treatment of pancreatic cancer domestically. Currently, a key registration Phase III clinical trial for this product in adjuvant therapy for pancreatic cancer is ongoing.