Thamadulin® (lanreotide acetate sustained-release injection) approved in China for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

April 3, 2024 (Shanghai) The biopharmaceutical company Ipsen announced that lanreotide acetate sustained-release injection (prefilled) (trade name: Somadulin®) was approved by China’s National Medical Products Administration on March 29 The FDA has officially approved it for use in adult patients with unresectable, well-differentiated or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; for use in adult patients with carcinoid syndrome: The frequency of emergency treatment with short-acting somatostatin analogues may be reduced while receiving this product.

As the only somatostatin analog (SSA) drug approved for deep subcutaneous self-injection in the world, Somadulin®’s precise efficacy, good safety, and convenient and comfortable injection experience have greatly benefited patients with gastroenteropancreatic neuroendocrine tumors. Bringing better treatment options and improving patient satisfaction.
In December 2019, Somadulin® was officially approved for the treatment of acromegaly in China and was included in the national medical insurance directory. In 2023, in the “Second Batch of Rare Disease Catalog” released by the National Health Commission, all diseases covered by Ipsen’s rare disease product pipeline are included, including acromegaly, gastroenteropancreatic neuroendocrine tumors, and progressive osteoarthritis. fibrous dysplasia, congenital biliary atresia, Alagille syndrome, primary biliary cholangitis, primary insulin-like growth factor-1 deficiency, etc.

Neuroendocrine tumors (NENs) are a type of rare tumors that originate from embryonic neuroendocrine cells, possess neuroendocrine markers, and produce peptide hormones. Among them, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) account for approximately 55%-70% of all neuroendocrine tumors. In China, the incidence rate of GEP-NETs is 1.14/100,000, and it takes an average of 4.8 years for patients to be diagnosed. In China’s second batch of rare disease catalogs announced in 2023, gastroenteropancreatic neuroendocrine tumors are included, further increasing public awareness and attention to the disease, promoting early diagnosis and treatment of the disease, and bringing more benefits to patients. beneficial.
The treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) covers a variety of methods. Somatostatin analogs (SSA) are the first-line drug treatment option for unresectable and/or metastatic gastroenteropancreatic neuroendocrine tumors. Somadulin® is a SSA treatment drug unanimously recommended by the European Neuroendocrine Tumor Society (ENETS) and domestic authoritative guidelines. It can significantly extend the progression-free survival (PFS) of patients to 38.5 months and reduce the risk of disease recurrence by 53%. It is applicable It has a wide population, complete clinical evidence, and high evidence-based level.