Recently, Grand Pharma's (00512) key strategic partner in the nuclear medicine field, Telix Pharmaceuticals Limited (TLX.US), prominently featured its globally innovative product TLX591-Tx at the 2026 ASCO Annual Meeting.

Initial data from Part 1 of its global Phase III clinical trial (ProstACT Global) for treating metastatic castration-resistant prostate cancer (mCRPC) was presented for the first time in an oral session, demonstrating the product's excellent clinical safety and pharmacokinetic profile, which fully validates its clinical potential. This product may become a new, powerful tool for the precise treatment of mCRPC in the future.

ASCO is the world's most prestigious and influential academic conference in the field of clinical oncology, with its annual oral presentations representing the forefront and key breakthroughs in global novel anti-cancer drug development. The impressive presentation of TLX591-Tx's clinical data at this conference fully validates the foresight of Grand Pharma's deep commitment to the nuclear medicine oncology diagnostics and therapeutics sector.

Targeting a Multi-Billion Dollar Prostate Cancer Market, Precision Combination Therapy Safety Validated by International Authorities

Prostate cancer is the second most common cancer and the fifth leading cause of cancer death in men globally, and it is also one of the cancers with the most significant growth rate over the past decade.

Latest data from the WHO's International Agency for Research on Cancer shows there were 1.468 million new prostate cancer cases worldwide in 2022, with nearly 400,000 deaths. Approximately 10-20% of patients with metastatic prostate cancer progress to castration-resistant prostate cancer within 5 years of follow-up, and the median survival after progression to castration resistance is about 14 months, indicating an extremely urgent clinical need.

The situation in China is equally concerning. According to data from the China National Cancer Center, the incidence rate of prostate cancer in national tumor registry areas rose from 10.2 per 100,000 in 2015 to 18.6 per 100,000 in 2022. With the growing patient population, clinical demand continues to rise. Frost & Sullivan forecasts that China's prostate cancer drug market size will surpass 50 billion yuan around 2030.

It is against this backdrop that nuclear medicine, with its advantages of precise targeting and integrated diagnosis and treatment, is becoming one of the most sought-after therapeutic paradigms in the prostate cancer field. TLX591-Tx is a first-in-class lutetium-labeled therapeutic radio-antibody drug conjugate (rADC) candidate. Its targeting and pharmacological properties are significantly different from existing marketed prostate-specific membrane antigen (PSMA)-targeting small peptide molecules, designed to achieve high internalization rates, long retention times, and high selectivity for PSMA.

The international multi-center Phase III trial, ProstACT Global, aims to evaluate this product combined with standard therapy (abiraterone, enzalutamide, or docetaxel) versus standard therapy alone in PSMA-positive mCRPC patients. The trial is divided into two parts: Part 1 is a safety and dosimetry run-in phase, which has completed enrollment of all 36 patients; Part 2 is a 2:1 randomized global expansion study, planning to enroll approximately 490 patients.

The data from Part 1 of the ProstACT Global study presented at ASCO showed that TLX591-Tx combined with standard of care (SoC) was well-tolerated with a favorable safety profile in mCRPC, and no new adverse reactions were observed. This provides key evidence-based support for the use of TLX591-Tx combined with SoC in treating mCRPC.

Regarding safety, the data indicated a favorable safety profile for the combination therapy group. The tolerability of TLX591-Tx was consistent with previous study results, with no new adverse reactions observed. Treatment-emergent adverse events were primarily transient and manageable hematological events, with incidence rates aligning with expectations for this type of therapy and disease severity.

Notably, TLX591-Tx uptake in salivary and lacrimal glands was extremely low, thereby reducing side effects like dry mouth and dry eyes. This means TLX591-Tx can be safely combined with contemporary mainstream standard of care, laying a solid foundation for the smooth progression of the subsequent randomized expansion phase.

Dosimetry results further validated the clinical advantages of TLX591-Tx. As a large-molecule rADC, the drug possesses the core advantage of ultra-long tumor retention. In the final imaging assessment 15 days after administration, stable radioactivity was still detectable within tumor lesions, and drug concentration in lesions was significantly higher than in normal tissues like the liver and kidneys, enabling long-acting targeted anti-tumor effects.

Simultaneously, normal organ radiation dose assessment results confirmed the safety of the regimen. Not only was there no clear risk of damage to the liver—an organ with relatively high radiation resistance—but radiation exposure to salivary glands and kidneys was relatively low. Radiation exposure levels for all normal organs were below clinical safety thresholds, providing dosimetry assurance for long-term combination therapy.

Furthermore, Part 2 of the global Phase III study for TLX591-Tx is actively progressing patient enrollment in approved regions, marking the study's transition from the safety and feasibility verification phase to the phase exploring the long-term survival benefits of the combination regimen. This is expected to further unlock the clinical application potential of this innovative product.

Global Full-Industry-Chain Layout Takes Shape, Grand Pharma's Leading Position in Nuclear Medicine Strengthens

The clinical data disclosed for TLX591-Tx validates the scientific and technical advantages of nuclear medicine in diagnosing and treating prostate cancer and confirms the strategic foresight of Grand Pharma's early entry into the nuclear medicine sector.

After years of dedicated effort, Grand Pharma has now achieved a comprehensive layout across multiple segments of the nuclear medicine sector, including R&D, production, distribution, and sales, establishing a global nuclear medicine industry chain.

To date, the company has a pipeline of 16 innovative products in the nuclear medicine oncology diagnostics and therapeutics segment, covering five key radionuclides (68Ga, 177Lu, 131I, 90Y, 89Zr) and comprehensively addressing seven high-incidence cancers including liver cancer, prostate cancer, renal cancer, and brain cancer, forming a well-rounded pipeline with synergistic diagnosis and treatment and multi-indication coverage.

Concurrently, the company has six innovative RDC drugs in registered clinical studies, one in the NDA stage, and three in Phase III clinical stages. It is the domestic company with the most diagnostic and therapeutic RDC innovative drug candidates in Phase III clinical studies, and also possesses a highly extensive product pipeline and integrated diagnosis-treatment layout advantages globally.

Among these, the company's self-developed, globally innovative small-molecule RDC drug GPN01530, which targets fibroblast activation protein (FAP), previously received FDA approval to initiate Phase I/II clinical studies for diagnosing solid tumors. This marks Grand Pharma's first self-developed RDC product to receive FDA approval for clinical studies. Preclinical research has shown its "best-in-class" (BIC) potential, and it may become the next-generation standard for cancer imaging.

The company's core flagship product, TheraSphere® Yttrium-90 (Y-90) Glass Microspheres, gained approval for new indications in both the US and Europe in 2025, further promoting comprehensive coverage in the field of unresectable liver cancer treatment and achieving a strategic expansion of market potential.

Currently, the company is pursuing an international "China-US dual submission" registration pathway, continuously developing new indications to accelerate global product penetration.

Regarding the industry chain, Grand Pharma's radioactive drug R&D and production base in Chengdu, Sichuan, has officially commenced operations. Equipped with 14 high-standard GMP production lines and achieving 100% independent production, it has completely overcome "chokepoint" challenges in the nuclear medicine field, eliminating import dependency.

This base is the world's first fully closed-loop platform covering the entire nuclear medicine industry chain and is one of the smart factories internationally with the most comprehensive range of radionuclides and the highest degree of automation. It can fully meet the company's needs for multi-variety, large-scale preparation of therapeutic and diagnostic nuclear medicines.

Leveraging its advantages of full-industry-chain autonomy and control, along with global operational capabilities, Grand Pharma is poised to continuously consolidate its leadership position in global nuclear medicine. It aims to consistently contribute China's nuclear medicine innovation technologies and high-quality diagnostic and therapeutic solutions, fostering the high-quality development of the global precision oncology diagnosis and treatment industry.