Positive news has emerged for the global radiopharmaceutical strategy of GRAND PHARMA (00512). The company's strategic partner in the field of Radioactive Drug Conjugates (RDC), Telix Pharmaceuticals Limited (TLX.US), has successfully held a Type B meeting with the U.S. FDA. The FDA has confirmed that the safety data from Part 1 of the global, multicenter Phase III clinical trial (ProstACT Global) for the innovative RDC drug TLX591-Tx can support the initiation of Part 2 of the trial in the United States.

Furthermore, the FDA and Telix have reached alignment on the clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan for Part 2. This regulatory consensus establishes a unified clinical research execution framework for TLX591-Tx, ensuring the continued patient enrollment in the ProstACT Global trial and the orderly expansion into U.S. clinical centers. As the global clinical development of TLX591-Tx progresses, it holds promise for offering a novel, precise treatment option for prostate cancer patients worldwide.

Validated Clinical Data Opens New Differentiated Treatment Pathway

TLX591-Tx is a global first-in-class, lutetium-labeled therapeutic radioactive antibody-drug conjugate (rADC) candidate. Its targeting and pharmacological properties are significantly different from existing approved prostate-specific membrane antigen (PSMA)-targeting small peptide molecules, designed to achieve high internalization rates, long retention times, and high selectivity for PSMA.

The product is currently advancing through a global, multicenter Phase III clinical trial to evaluate the efficacy of TLX591-Tx combined with standard therapy compared to standard therapy alone. The trial is divided into two parts: Part 1 focuses on safety and dosimetry, while Part 2 is a global expansion study with a 2:1 randomization.

Key results from Part 1 of the ProstACT Global trial, previously presented, demonstrated that TLX591-Tx combined with standard therapy was well-tolerated with a manageable safety profile. Hematological events were transient and controllable, radiation exposure to key organs was safe, and the drug exhibited excellent tumor retention with no significant drug-drug interactions observed.

Simultaneously, compared to other PSMA-targeting small molecule radioligand therapies, TLX591-Tx treatment demonstrated distinct targeting and pharmacological characteristics. Long-term follow-up of patients treated with TLX591-Tx showed no significant acute or delayed nephrotoxicity. Furthermore, due to its larger molecular size, TLX591-Tx showed very low uptake in salivary and lacrimal glands, thereby reducing side effects like dry mouth and dry eyes.

The favorable safety and pharmacokinetic profile established in Part 1 of the trial lays a solid foundation for the subsequent large-scale efficacy validation of TLX591-Tx. The approved Part 2 of the Phase III trial plans to enroll approximately 490 metastatic castration-resistant prostate cancer patients globally, who have been diagnosed via 68Ga-PSMA-11 PET imaging and have prior treatment with androgen receptor pathway inhibitors.

Prostate cancer is a prevalent malignancy among men globally, and its market size is expanding rapidly, driven by population aging in both global and Chinese markets. The global prostate cancer drug market is projected to grow significantly in the coming years.

In this context, TLX591-Tx has the potential to establish a differentiated competitive advantage due to its lower toxicity profile and better suitability for combination therapy compared to similar treatments. This could provide a new diagnostic and therapeutic option for prostate cancer patients, further solidifying the company's leading position in the field of radiopharmaceutical oncology.

Diversified Pipeline and a Deepened Integrated Development System

The positive clinical data for TLX591-Tx validates the clinical value of radiopharmaceuticals in treating prostate cancer and highlights the foresight of the company's strategic focus on this sector. The company has established a complete ecosystem for radiopharmaceutical oncology, encompassing everything from manufacturing to a global commercialization system, continuously reinforcing its industry leadership.

Currently, the company has a robust pipeline of over 16 innovative products in various stages of research and registration. This pipeline covers five different radioactive isotopes and targets seven cancer types, including liver, prostate, and brain cancers.

Among its numerous radiopharmaceutical candidates, six innovative RDC drugs have been approved for registrational clinical studies. One has reached the NDA stage, and three are in Phase III clinical trials. These include diagnostic and therapeutic products for prostate cancer, a diagnostic for renal cell carcinoma, and a therapeutic for neuroendocrine tumors.

Concurrently, the company's self-developed pipeline continues to achieve new milestones, further validating its innovative capabilities in the radiopharmaceutical field. Its first self-developed RDC product has received FDA approval to initiate clinical studies in the U.S., showcasing the company's strong preclinical development and international regulatory capabilities.

Another self-developed diagnostic RDC candidate targeting liver cancer has achieved a breakthrough milestone in a Chinese clinical study and received recognition at a major international conference, demonstrating its potential to become a global first-in-class diagnostic product for its target.

The realization of this innovative pipeline is supported by a comprehensive industrial platform. After years of development, the company has established a first-of-its-kind, fully integrated radiopharmaceutical platform in China. Its research, development, and production base covers the entire chain from isotope production to commercialization.

This facility enables full lifecycle management from early R&D to market sales, addresses critical supply chain challenges, and achieves 100% self-sufficient production, breaking reliance on imports. It is recognized as one of the most automated and comprehensive radiopharmaceutical production facilities globally.

This base will further solidify the foundation of the company's radiopharmaceutical business, accelerate the development of its global innovative pipeline, and drive high-quality growth in its radiopharmaceutical segment, cultivating high-value blockbuster products.

Looking ahead, as the global radiopharmaceutical market continues to expand, the company is well-positioned to deepen its global development strategy. Leveraging its first-mover advantage and full-industry-chain capabilities, it aims to further increase its market share in the global radiopharmaceutical arena, consistently delivering innovative Chinese radiopharmaceutical technologies and high-quality treatment solutions to benefit cancer patients worldwide.