China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its lutetium [177Lu] oxy-octreotide. The drug is being developed to treat unresectable or metastatic, progressive, well-differentiated (G1 and G2) neuroendocrine tumors that are somatostatin receptor-positive, specifically targeting gastrointestinal and pancreatic neuroendocrine tumors (GEP-NETs).
Drug Background and Development
Hengrui’s lutetium [177Lu] oxy-octreotide is a version of Lutathera, a therapeutic radiopharmaceutical originally developed by Advanced Accelerator Applications, a subsidiary of Novartis. Lutathera is a somatostatin analog radiolabeled with lutetium-177 (177Lu), which binds to somatostatin receptors highly expressed in neuroendocrine tumors. This targeted approach allows the drug to deliver radiation directly to cancer cells, minimizing damage to surrounding healthy tissue.
Global and China Market Landscape
Lutathera has received marketing approvals in the EU (2017), US (2018), and Japan (2021). The drug generated USD 475 million in global sales in 2021. Currently, there is no similar product available on the market in China, positioning Hengrui’s lutetium [177Lu] oxy-octreotide as a potential first-mover in addressing this significant unmet medical need.-Fineline Info & Tech
