Recently, LNC received the 177Lu-LNC1003 Injection IND approval from the NMPA (National Medical Products Administration), and will conduct the Phase I clinical trial in the near future.
The global approval status of 177Lu-LNC1003 injection is as follows:
Apr. 2023, United States
LNC PHARMA received the US FDA (Food and Drug Administration) IND approval for 177Lu-LNC1003 injection.
Nov. 2023, Singapore
LNC PHARMA received the Singapore HSA (Health Sciences Authority) IND approval for 177Lu-LNC1003 injection.
Nov. 2023, China
LNC received the Chinese NMPA ((National Medical Products Administration) IND approval for 177Lu-LNC1003 injection.
—— About 177Lu-LNC1003 injection ——
177Lu-LNC1003 Injection is a PSMA-targeted radionuclide therapeutic drug, currently entered the Phase I clinical trial. Suitable for patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). The targeting specificity of PSMA enables the delivery of radionuclide Lu-177 to the lesion site. Lu-177 is a therapeutic nuclide with an average range of 670 μm in tissues due to its relatively low β-particle energy. It has a relatively less suppressive effect on the bone marrow, which can kill tumor cells in a safer and more effective way to reduce side effects on human body.
LNC was jointly founded by DC PHARMA and Professor Chen Xiaoyuan, a top expert in molecular imaging and nanomedicine, in 2021. Adhering to the concept of "Innovation-driven Micro Radiotheranostics R&D, Benefit People from Precision Therapy", LNC is focusing on the construction of a globally leading integrated diagnosis and therapy innovation platform on cancer nuclear medicine R&D. Next, LNC will continue to rely on DC PHARMA's strong and sound production and research system for the entire nuclear medicine industry chain, strengthen innovation, providing precision diagnosis and therapeutic methods for cancer patients and promoting the development of nuclear medicine in the world.