On May 8, the 3 generic drugs "Lutetium [177Lu] oxotreotide injection" developed by HTA Co., LTD. (referred to as HTA) officially obtained the "Drug Clinical Trial Approval Notice" approved and issued by the State Medical Products Administration (NMPA). Consent to a clinical trial for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive adult gastroentero-pancreatic neuroendocrine tumors (GEP-NETs). This is another important advance for HTA in the registration of radiotherapeutic drugs following the therapeutic capsule.

　　Neuroendocrine Neoplasms (NENs) are tumors of neuroendocrine cells originating throughout the body. NENs can be divided into several categories, of which gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are the most common, accounting for about 2/3 of all NENs. The favoured sites of GEP-NETs in European and American Caucasians were small intestine, rectum, pancreas and stomach, while those in Chinese were pancreas, rectum and stomach. In recent years, the incidence of NENs has been increasing.

　　Peptide receptor radionuclide therapy (PRRT) is to label the radionuclides emitting α or β rays on tumor-targeting peptides, exert the local irradiation ability of radionuclides, and destroy the DNA of tumor cells to achieve the purpose of killing tumor. PRRT drugs commonly used to treat NETs are β-emitting 90Y, 177Lu, or α-emitting 225Ac and 213Bi, which are labeled on somatostatin (SST) octopeptides (such as TATE and TOC), which can bind specifically to somatostatin receptors (SSTR) and further internalize into cells. Among them, Lutetium [177Lu] oxyoctreotide injection (trade name: Lutathera®) has been approved by the European Medicines Agency and the United States Food and Drug Administration in September 2017 and January 2018, respectively, and there are no similar drugs on the market in China.

　　HTA has obtained the clinical trial approval of NETs diagnostic drug "Gallium [68Ga] Dot-amlotide injection" in February this year, and now "Lutetium [177Lu] oxyoctreotide injection" has been approved for clinical use, which is expected to realize the integration of diagnosis and treatment of NET patients in China, and promote nuclear medicine to "treat what I see, see what I treat" to play a unique advantage in precision medicine. Bring good news to the majority of NET patients.