CSPC Group (01093): New indications for Doenyi® (irinotecan hydrochloride liposome injection) were approved for marketing

Zhitong Finance App News, Shiyao Group (01093) announced that the new indications for irinotecan hydrochloride liposome injection (product name: Duonyi®) developed by the Group have been approved for marketing by the China Drug Administration. The new indication approved this time is the first-line treatment of patients with metastatic pancreatic cancer in combination with oxaliplatin, 5-fluorouracil (5-FU), and folic acid (LV).

The approval of this indication is mainly based on a key clinical trial for patients with unresectable locally advanced or metastatic pancreatic cancer who have not received systemic antineoplastic treatment and are histologically or cytologically confirmed. Results already disclosed at the 2024 American Society of Clinical Oncology (ASCO) annual meeting showed that the product can significantly prolong progression-free survival (PFS) (risk ratio (HR) of 0.55, reducing the risk of disease progression or death by 45%) for first-line treatment of advanced pancreatic cancer, showing a trend of benefits in terms of objective remission rate (ORR), duration of remission (DOR), and overall survival (OS), and has good safety. Compared with conventional formulations, it has achieved detoxification and efficacy.

The product was approved for marketing in China on September 15, 2023. The first approved indication is for patients with metastatic pancreatic cancer progressing after receiving gemcitabine treatment in combination with 5-fluorouracil (5-FU) and folic acid (LV). It is the first irinotecan hydrochloride liposome injection approved for marketing by a domestic company. The approved indication is the second indication approved for this product in China. It is also the first time that irinotecan liposome injection has been approved for first-line treatment of pancreatic cancer in China. Currently, critical registration phase III clinical trials of this product for adjuvant treatment after surgery for pancreatic cancer are ongoing.