Grand Pharma (00512) is making significant strides in its radiopharmaceutical pipeline. Following the FDA approval of its self-developed global innovative FAP-targeted radiopharmaceutical conjugate (RDC) GPN01530 for Phase I/II clinical trials in the U.S., the company announced another milestone on December 21. Its innovative RDC drug TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11), designed for diagnosing prostate cancer, has achieved positive top-line results in China's Phase III clinical trial, successfully meeting the primary endpoint. This paves the way for TLX591-CDx to enter the new drug application phase, with commercialization on the horizon.
The consecutive breakthroughs in Grand Pharma's radiopharmaceutical segment not only deepen its integrated diagnosis-treatment product blueprint but also highlight the company's phased progress in globalizing its radiopharmaceutical business, reinforcing its competitive edge in the field.
**TLX591-CDx Demonstrates Strong Clinical Data, Integrated Diagnosis-Treatment Portfolio Ready for Launch** According to the announcement, TLX591-CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) using radionuclide-small molecule conjugate technology. It is indicated for both initial diagnosis and recurrent prostate cancer. Public data show that TLX591-CDx's targeting agent, PSMA-11, binds with high affinity to PSMA, which is highly expressed in prostate cancer. It features five key characteristics: cellular internalization, stable biological activity, short in vivo half-life, strong tumor penetration, and rapid clearance from non-target tissues.
The top-line clinical results reveal TLX591-CDx's high diagnostic accuracy, with an overall positive predictive value (PPV) of 94.8% for tumor detection. Its PPV for prostate bed recurrence and non-bone metastatic tumors reached 100.0%. Additionally, TLX591-CDx showed high PPV for bone metastases and patients with varying baseline prostate-specific antigen (PSA) levels. These results underscore the clinical significance of TLX591-CDx's PET imaging in early diagnosis for suspected biochemical recurrence, potentially enabling earlier disease progression detection and critical treatment windows.
Moreover, over two-thirds of patients saw adjustments to their treatment plans post TLX591-CDx PET imaging, demonstrating its impact on clinical decision-making and optimization of treatment strategies for suspected biochemical recurrence.
The robust clinical data not only validate TLX591-CDx's diagnostic accuracy and utility but also provide solid evidence for its upcoming new drug application in China. TLX591-CDx's commercial potential is already evident globally, with approvals in the U.S., Australia, Canada, Brazil, and the U.K. In 2024, it generated approximately $517 million in sales, with $461 million in the first three quarters of 2025, reflecting over 25% year-on-year growth—a strong indicator of its prospects in China.
**Key Step Toward Integrated Prostate Cancer Portfolio** The success of TLX591-CDx's Phase III trial marks a critical step for Grand Pharma in building an integrated prostate cancer radiopharmaceutical portfolio. Another innovative RDC product, TLX591, has been approved for international multi-center Phase III clinical studies in China. Early clinical results suggest TLX591 may surpass existing anti-PSMA small peptide RLT molecules, potentially redefining treatment standards for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
Prostate cancer is a prevalent malignancy among Chinese men, with rising incidence and mortality rates due to factors like aging populations. Frost & Sullivan projects China's prostate cancer cases to exceed 165,000 by 2030, with a drug market size of approximately RMB 37.6 billion. Grand Pharma's dual-product strategy aims to deliver precise, efficient solutions, improving patient outcomes while creating commercial synergies and solidifying its leadership in radiopharmaceuticals.
**Global Leadership in Radiopharmaceuticals** Grand Pharma's breakthroughs stem from years of dedication to the field. The company has established a comprehensive radiopharmaceutical ecosystem spanning R&D, production, distribution, and sales, with hubs in Boston, Frankfurt, Singapore, and Chengdu, supported by a global sales network covering 50+ countries.
Its pipeline includes 16 innovative products in development, targeting seven cancer types (e.g., liver, prostate, brain cancers) using five radionuclides (68Ga, 177Lu, 131I, 90Y, 89Zr). Early-stage R&D focuses on RDC drugs, with over 10 candidates spanning diagnostic and therapeutic radiopharmaceuticals. Six innovative RDCs are in registrational clinical trials, four of which are in Phase III.
Notably, SIR-Spheres® Yttrium-90 microspheres (Y-90) gained early U.S. approval for unresectable hepatocellular carcinoma (HCC) in July and expanded European CE indications in September, becoming the only FDA-approved selective internal radiotherapy for unresectable HCC and colorectal liver metastases. Meanwhile, GPN02006, a self-developed GPC-3-targeted diagnostic radiopharmaceutical, achieved milestone results in China and earned an oral presentation at the 2025 SNMMI Annual Meeting, positioning it as a potential global first-in-class HCC diagnostic RDC.
Grand Pharma's self-developed FAP-targeted RDC, GPN01530, recently secured FDA approval for Phase I/II trials in the U.S., showcasing "best-in-class" potential and underscoring the company's preclinical and international regulatory capabilities.
**Expanding Global Footprint** Grand Pharma's Chengdu radiopharmaceutical R&D and production base—the world's first fully integrated closed-loop platform—obtained a Class A Radiation Safety License in May 2025 and commenced operations in June. As one of the most automated smart factories globally, it supports large-scale production of diagnostic and therapeutic radiopharmaceuticals.
With the global radiopharmaceutical market expanding, Grand Pharma is poised to leverage its first-mover advantage and full-chain capabilities to execute its "Go Global" strategy, enhancing its global market share and advancing China's role in the global radiopharmaceutical arena.
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