Grand Pharmaceutical (00512) announced that the New Drug Application (NDA) for its innovative investigational radiopharmaceutical conjugate (RDC) TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11), intended for diagnosing prostate cancer, has been formally submitted to and accepted by China's National Medical Products Administration (NMPA). This marks a significant R&D milestone for the Group within the field of nuclear medicine for oncology theranostics.
Furthermore, the Group's therapeutic RDC product for prostate cancer, TLX591, has been approved in China to join an international multi-center Phase III clinical study. The future combination of these two products is poised to offer more precise and efficient diagnostic and therapeutic solutions for prostate cancer patients in China.
The NDA submission includes data from the TLX591-CDx clinical study in China, which reported positive preliminary results in December 2025. This single-arm, open-label Phase III study evaluated the diagnostic efficacy, safety, and tolerability of TLX591-CDx in over 100 Chinese patients with biochemical recurrence of prostate cancer using PET/CT or PET/MRI imaging.
According to the clinical topline results, TLX591-CDx demonstrated an overall positive predictive value (PPV) of 94.8% (CI: 85.9%-98.2%) for tumor detection. This confirms that the diagnostic clinical experience for Chinese patients is comparable to study results in non-Chinese populations, with the PPV remaining consistently high even in patients with very low PSA values and across different metastatic sites.
Additionally, treatment plans were adjusted from the initial baseline regimen for over two-thirds (67.2%) of patients following TLX591-CDx PET imaging. This indicates that TLX591-CDx PET imaging has a significant impact on clinical decision-making, optimizing treatment strategies for patients with suspected biochemical recurrence of prostate cancer.
Previously, in November 2020, the Group entered into a strategic product cooperation agreement with Telix Pharmaceutical Limited (ASX: TLX; NASDAQ: TLX) and its global subsidiaries, securing exclusive rights for several innovative RDC products, including TLX591, TLX591-CDx, and TLX250-CDx, in Greater China (Mainland China, Hong Kong SAR, Macau SAR, and Taiwan).
TLX591-CDx is a globally innovative, targeted diagnostic radiopharmaceutical for prostate-specific membrane antigen (PSMA), based on radionuclide-small molecule conjugate technology, and is suitable for diagnosing both newly diagnosed and recurrent prostate cancer.
Based on public data, the targeting agent PSMA-11 in TLX591-CDx specifically binds with high affinity to PSMA, which is highly expressed in prostate cancer cells. It features five key characteristics: ability to internalize into cells, stable biological activity, short in-vivo circulation half-life, good penetration into tumor tissue, and rapid clearance from non-target tissues.
TLX591-CDx received marketing approval in Australia in November 2021, followed by the US in December 2021. It was approved in Canada in October 2022. In March 2023, its US indication was expanded for selecting prostate cancer patients eligible for PSMA-targeted radioligand therapy, with this expanded indication subsequently approved in Australia and Canada in October 2024.
By 2025, TLX591-CDx had gained commercial approval in numerous countries including Austria, Belgium, Brazil, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, and the UK.
The product achieved sales of approximately $517 million in 2024, with sales reaching about $461 million in the first three quarters of 2025, representing a year-on-year increase of over 25%.
The Group has established a comprehensive layout across R&D, production, distribution, and sales in its nuclear medicine oncology theranostics segment. With a global team exceeding 900 employees, R&D hubs in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries and regions, the Group has achieved a globalized nuclear medicine industry chain.
Collaborating with Sirtex Medical Pty Ltd, Telix, and ITM Isotope Technologies Munich SE (ITM SE), the Group has built internationally top-tier R&D platforms for interventional oncology and RDC drugs.
Centered on the concept of integrated diagnosis and treatment, the segment currently has a pipeline of 16 innovative products in the R&D registration stage, utilizing five radionuclides (68Ga, 177Lu, 131I, 90Y, 89Zr) and targeting seven cancer types, including liver cancer, prostate cancer, and brain cancer. The early-stage R&D pipeline, primarily focused on RDCs, includes over 10 products.
The product portfolio encompasses both diagnostic and therapeutic radiopharmaceuticals, aiming to provide patients with multi-indication treatment options and leading global integrated theranostic solutions. Global R&D for the segment's innovative products is progressing smoothly.
In China, TheraSphere® Yttrium-90 [90Y] Microspheres (Yigan Tai®) were successfully launched in January 2022 for treating colorectal cancer liver metastases and received NMPA approval in May 2025 to initiate a Phase II registrational clinical trial for unresectable HCC. The global innovative temperature-sensitive embolic agent GPN00289 completed patient enrollment for its registrational clinical study in October 2025.
Regarding overseas registrations, SIR-Spheres® Yttrium-90 [90Y] Microspheres (Yigan Tai®) received FDA approval ahead of schedule in July 2025 for a new indication treating unresectable HCC, making it the first and only selective internal radiotherapy product globally with dual FDA approval for unresectable HCC and colorectal cancer liver metastases.
In September 2025, it obtained the CE mark in Europe for additional liver cancer indications, further promoting comprehensive coverage in the unresectable liver cancer treatment field and achieving strategic market expansion. This demonstrates the Group's strong capabilities in overseas clinical registration and commercial operation, providing crucial support for the global development of subsequent self-developed innovative nuclear drugs. Relevant overseas clinical data will also support the product's indication expansion for liver cancer in China.
Additionally, the Group is collaborating with domestic and international experts to develop other indications for Yttrium-90 [90Y] Microspheres, adopting an international "simultaneous China-US submission" registration pathway to accelerate global market expansion.
Currently, the Group has six innovative RDCs in the nuclear medicine oncology segment approved for registrational clinical studies, with four already in Phase III, including the diagnostic product TLX591-CDx for prostate cancer, the therapeutic product TLX591 for prostate cancer, the diagnostic product TLX250-CDx for clear cell renal cell carcinoma, and the therapeutic product ITM-11 for gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Recently, the Group's self-developed, globally innovative small molecule RDC drug GPN01530, targeting fibroblast activation protein (FAP), received FDA approval to initiate a Phase I/II clinical study for diagnosing solid tumors. This product is the Group's first self-developed RDC to receive FDA approval for clinical studies. Its successful approval provides an important paradigm for the international development of the Group's nuclear medicine pipeline and showcases the excellent preclinical development and international registration capabilities of its nuclear medicine technology platform, marking a significant milestone in the segment's global R&D and registration progress.
The marketing application for ITM-11, submitted by the Group's partner ITM SE in the US, has been formally accepted by the FDA. Furthermore, the investigator-initiated trial (IIT) in China for GPN02006, a globally innovative diagnostic radiopharmaceutical targeting Glypican-3 (GPC-3) based on radionuclide-antibody conjugate technology, achieved a milestone breakthrough and was selected for an oral presentation at the 2025 SNMMI Annual Meeting. This product holds significant potential to become the world's first GPC-3-targeted diagnostic RDC for hepatocellular carcinoma (HCC).
To date, the Group possesses the largest total pipeline of innovative diagnostic and therapeutic RDCs in Phase III clinical studies in China and is one of the innovative pharmaceutical companies globally with the richest product pipeline and most comprehensive theranostic layout in the nuclear medicine oncology field.
The Group's radiopharmaceutical R&D and production base in Wenjiang District, Chengdu, Sichuan Province, passed final inspection and acceptance in April 2025, obtained a Class A Radiation Safety License from the Ministry of Ecology and Environment in May 2025, and officially commenced operations at the end of June 2025.
This base is the world's first fully integrated, closed-loop platform for the nuclear medicine industry chain, covering the entire spectrum from "isotope preparation - nuclear drug R&D - clinical production - commercialization." It establishes full lifecycle management capabilities from early R&D to clinical translation and market launch, with internationally leading R&D efficiency.
It addresses critical challenges in nuclear medicine supply, achieving 100% independent production to break dependence on imports. Fourteen high-standard GMP production lines meet multi-product, large-scale preparation demands. A fully intelligent management system ensures nuclear-power-level safety and unmanned smart manufacturing, achieving "zero radiation leakage," "zero external pollution discharge," and "zero exceedance of occupational exposure limits," meeting top global nuclear facility standards.
Establishing a world-class R&D, production, quality, and operation system, it is one of the most automated smart factories globally with the most comprehensive range of radionuclides. This R&D and production base will further consolidate the foundation of the Group's nuclear medicine industry, accelerate the implementation of its global innovative R&D pipeline, promote high-quality development in the nuclear medicine sector, cultivate high-value blockbuster products, and lay a solid foundation for the localization of the Group's radiopharmaceuticals.
Moving forward, the Group will continue to strengthen R&D and development in the nuclear medicine oncology theranostics segment, enrich and perfect its product pipeline and industrial layout, and form a product cluster centered around TheraSphere® Yttrium-90 [90Y] Microspheres, continuously solidifying its position as a leading enterprise in the global nuclear medicine oncology theranostics field.
The Group consistently places high importance on the R&D of innovative products and advanced technologies. Centered on patient needs and driven by technological innovation, it focuses on addressing unmet clinical demands, increasing investment in globally innovative products and advanced technologies, enriching and perfecting its product pipeline and industrial layout.
Adopting a strategy of "global operational layout, dual-circulation business development," the Group aims to create a new pattern of synergistic domestic and international development, fully leveraging its industrial advantages and R&D strength to rapidly bring scientific and technological innovation products to market, providing global patients with more advanced and diverse treatment options.
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