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 endows the relevant drug with the potential to explore therapeutic applications across multiple solid tumor types.

This IND approval marks another milestone for Jiluntai following the market approval of its integrin αvβ3-targeted imaging radiopharmaceutical ⁹⁹ᵐTc-3PRGD2 in April this year. The company stated that the entry of ¹⁷⁷Lu-AB-3PRGD2 into the registered clinical stage signifies that its radiopharmaceutical R&D around the same target has extended from the diagnostic end to the therapeutic end, further advancing its theranostics integration strategy.

Prior to obtaining the IND, ¹⁷⁷Lu-AB-3PRGD2 Injection had already undergone investigator-initiated trials (IIT). The relevant study enrolled 22 patients with advanced metastatic solid tumors, covering 13 cancer types including radioiodine-refractory thyroid cancer, breast cancer, lung cancer, cholangiocarcinoma, and renal cancer, with most patients being end-stage cancer patients who had poor prognoses and lacked effective treatment options.

Study results showed that the best overall disease control rate (DCR) during treatment across all patients was 90%. Among patients who received at least 3 cycles of treatment, 50% achieved stable disease (SD) and 20% achieved partial response (PR), with a DCR of 70% in this subgroup. Among patients who received at least 2 cycles of treatment, the median progression-free survival (PFS) was 6.4 months and the median overall survival (OS) was 18.5 months. The study also demonstrated that the drug was generally well tolerated in the relevant patient population.

Jiluntai was founded by Professor Wang Fan of Peking University. The core R&D team relies on the "Peking University Medicine-Jiluntai Nuclear Medicine Molecular Imaging Joint Laboratory" and has established a radiopharmaceutical R&D platform covering isotope labeling, targeted molecule screening and optimization, preclinical evaluation, and clinical translation. Currently, the company's pipeline encompasses SPECT diagnostic agents, PET diagnostic agents, and targeted therapeutic agents. In 2022, Baiyang Pharmaceutical Group made a strategic investment in Jiluntai, entering the innovative radiopharmaceutical field.