The application for Grand Pharma’s global innovative investigational radionuclide-drug conjugate (RDC) TLX591 (177Lu-rosopatamab tetraxetan) for the treatment of prostate cancer to join an international multicenter Phase III clinical trial has obtained implied approval from the National Medical Products Administration of the People’s Republic of China (NMPA). This represents a significant R&D progress for the Group in the field of nuclear medicine anti-tumor diagnosis and treatment. The Group attaches great importance to the global development strategy of the nuclear medicine industry, actively promotes the global development and registration process of innovative nuclear medicine products, and will continuously deepen the global expansion of the Group’s nuclear medicine product pipeline.
- TLX591, with its precise targeting and differentiated pharmacological properties, has demonstrated clinical potential to surpass existing PSMA-targeted small-peptide RLT molecules. It is expected to redefine the treatment standard for PSMA-positive mCRPC.
- TLX591 only requires a two-dose regimen administered approximately 14 days apart, which significantly shortens the treatment cycle, markedly improving patient compliance and convenience. This breakthrough dosing regimen and trial design addresses the clinical pain points such as long treatment cycles and heavy patient burden associated with existing therapies.
- The Phase III clinical trials of TLX591 and TLX591-CDx in China are critical to the Group to achieve comprehensive coverage of “integrated diagnosis and treatment” of prostate cancer, which is expected to deliver more precise and effective diagnostic and therapeutic solutions for patients with prostate diseases in China.
