By Fineline Cube China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its TLX101, a radionuclide drug conjugate (RDC) being developed to treat glioblastoma multiforme, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of innovative treatments for this aggressive form of brain cancer.
TLX101: Radionuclide Drug Conjugate
TLX101 (131I-IPA) is designed to pass the blood-brain barrier, a critical feature for effective treatment of glioblastoma multiforme. The drug has already obtained orphan drug designation (ODD) status in the US and has entered Phase I/II clinical trials in Europe and Australia. This global development strategy underscores Grand Pharma’s commitment to bringing this innovative treatment to patients worldwide.
Nuclear Pharmaceuticals Pipeline
Grand Pharma is doubling down on nuclear pharmaceuticals for the treatment of tumors, having developed 13 innovative products. These include six radionuclides—68Ga, 177Lu, 131I, 90Y, 89Zr, and 99mTc—covering eight cancer species, including liver cancer, prostate cancer, and brain cancer. The company’s core product, yttrium [90Y] microsphere, obtained marketing approval in China in January of last year for use in liver cancers, highlighting Grand Pharma’s leadership in this field.-Fineline Info & Tech