China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its irinotecan liposome injection. The drug is indicated for the treatment of metastatic pancreatic cancer in patients after gemcitabine treatment and is also used in combination with 5-fluorouracil plus folinic acid.
Irinotecan’s Mechanism of Action and Clinical Utility
Irinotecan is a semisynthetic derivative of camptothecin, a compound that specifically binds to Topoisomerase I, inducing reversible single-strand breaks in DNA, which helps to unwind the double helix. Irinotecan hydrochloride and its active metabolite SN-38 can bind to the topoisomerase I-DNA complex, preventing the reconnection of broken single strands. This mechanism of action makes irinotecan a valuable agent in cancer treatment. The drug, originally developed by Merrimack Pharmaceuticals, has been approved for marketing in the US, Europe, South Korea, Singapore, and Japan since 2015. In China, it obtained market approval in April 2022, with the application filed by Servier.
CSPC’s Innovative Generic Version and Market Competitiveness
CSPC’s generic version of irinotecan utilizes a new drug loading technology, which offers superior performance compared to the traditional ammonium sulfate gradient method, boasting a higher drug loading capacity. This advancement positions CSPC’s product as a competitive option in the market. Meanwhile, Hengrui Medicine’s generic version of the drug is still awaiting a regulatory decision.-Fineline Info & Tech
