China-based Jiangxi Jemincare Group announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its irinotecan liposome injection. This approval marks the second such generic drug to gain approval in China and is deemed bioequivalent to the originator product. The injection offers a new treatment option for patients with advanced pancreatic cancer.
Product Advantages
The irinotecan liposome injection developed by Jemincare features enhanced tumor targeting and biocompatibility compared to traditional irinotecan injections. It significantly reduces toxicities such as myelosuppression and diarrhea, thereby improving treatment tolerance for patients. Global studies have demonstrated that the irinotecan liposome in combination with 5-FU/LV regimen extends median progression-free survival (PFS) and overall survival (OS) in patients with metastatic pancreatic cancer.
Previous Approval and Equivalence
In April 2022, Servier’s Onivyde (irinotecan liposome) was approved in China for use in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for the treatment of gemcitabine-refractory metastatic pancreatic cancer. Clinical trials have confirmed 100% pharmacokinetic equivalence between Jemincare’s generic product and the originator.-Fineline Info & Tech
