Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed at improving progression-free survival and managing carcinoid syndrome. This treatment may help reduce the frequency of emergency interventions with short-acting somatostatin analogues.
Originally approved in December 2019 for treating acromegaly in China, Somatuline is the only somatostatin analogue (SSA) designed for deep subcutaneous self-injection. Ipsen’s portfolio of rare disease drugs has benefited from the expansion of China’s official rare disease list in 2023, which includes indications for acromegaly, gastrointestinal and pancreatic neuroendocrine tumors, and several other conditions.
Neuroendocrine tumors (NENs) are a rare category of tumors derived from embryonic neuroendocrine cells, characterized by neuroendocrine markers and the capacity to produce peptide hormones. GEP-NETs represent approximately 55% to 70% of all neuroendocrine tumors, with an incidence rate of 114 per 100,000 in China. Patients typically face an average diagnosis delay of 4.8 years. Somatostatin analogues are recognized as first-line treatments for unresectable and/or metastatic GEP-NETs. Somatuline, endorsed by the European Neuroendocrine Tumor Society (ENETS) and key guidelines in China, has demonstrated the ability to extend progression-free survival by an average of 38.5 months and reduce disease recurrence risk by 53%, supported by robust clinical evidence.- Flcube.com
