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Beijing Jiluntai's ¹⁷⁷Lu-JLT003 Injection Receives IND Approval for Treatment of Integrin αvβ3-Positive Malignant Tumors

Beijing Jiluntai Pharmaceutical Co., Ltd. has recently achieved progress in radiopharmaceutical R&D. Its self-developed Class 1 innovative therapeutic radiopharmaceutical ¹⁷⁷Lu-JLT003 Injection (generic name: ¹⁷⁷Lu-AB-3PRGD2) has obtained the Clinical Trial Approval (IND) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), intended for the treatment of integrin αvβ3-positive malignant tumors. ¹⁷⁷Lu-AB-3PRGD2 is a therapeutic radiopharmaceutical targeting integrin αvβ3. Integrin αvβ3 is highly expressed on various solid tumor cells and tumor neovascular endothelial cells, while showing low expression in normal tissues, a characteristic that...

2026-09-01

Novartis Files Localized Production Application in China for Lutetium [177Lu] Vipivotide Tetraxetan

On August 24, information on the website of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration showed that Novartis' nuclear medicine product Lutetium [177Lu] Vipivotide Tetraxetan had a localized production application submitted in China. On the same day, two indications for the drug were proposed for priority review, and the relevant review matters may correspond to this localized production application. Lutetium [177Lu] Vipivotide Tetraxetan, namely 177Lu-PSMA-617, is a radioligand therapy (RLT) drug acquired by Novartis following its acquisition of Endocyte. The drug consists of a small-molecule compound targeting prostate-specific membrane antigen (PSMA) conjugated to the therapeutic radionuclide Lutetium-177. Upon entering the bloodstream, the drug binds to prostate cancer cells expressing PSMA, and...

2026-08-25

ITM Receives Complete Response Letter from FDA for ¹⁷⁷Lu-edotreotide New Drug Application

Radiopharmaceutical biotechnology company ITM Isotope Technologies Munich SE (ITM) announced on August 10 that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding the New Drug Application (NDA) for its investigational drug ¹⁷⁷Lu-edotreotide (ITM-11). The drug is intended for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

2026-08-11