GRAND PHARMA(00512): The new drug application for innovative radiolabeled drug TLX591-CDx has been accepted by the China Food and Drug Administration.

GRAND PHARMA (00512) announced that the group's innovative investigational radiolabeled drug candidate (RDC) TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11) for diagnosing prostate cancer has recently submitted a New Drug Application (NDA) to the National Medical Products Administration of the People's Republic of China (NMPA) and has been accepted. This marks an important development in the group's research and development in the field of nuclear medicine for cancer diagnosis and treatment. Additionally, the RDC product TLX591 for treating prostate cancer has been approved to join an international multicenter Phase III clinical trial in China. In the future, the combination of these two products is expected to provide more precise and effective treatment options for prostate cancer patients in China. The NDA application includes data from the TLX591-CDx China clinical study, which reported positive preliminary results in December 2025. The study, a single-arm, open-label Phase III clinical trial, involved over 100 prostate cancer biochemical recurrence patients who were administered TLX591-CDx and underwent positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance imaging (PET/MRI) scans to evaluate the diagnostic efficacy of the product and assess its safety and tolerability in the Chinese population. According to the top-line results, TLX591 CDx demonstrated an overall positive predictive value (PPV) of 94.8% (confidence interval, CI: 85.9%-98.2%), confirming that the clinical experience with TLX591-CDx for diagnosing Chinese patients is comparable to the results of studies on non-Chinese patients, even in patients with very low prostate-specific antigen (PSA) values and at different metastatic sites, maintaining a high PPV. Furthermore, over two-thirds (67.2%) of the patients had adjustments made to their treatment plans after undergoing PET imaging with TLX591-CDx compared to their initial baseline plans. This indicates that PET imaging with TLX591-CDx has a significant impact on clinical decisions, optimizing the clinical treatment strategies for prostate cancer patients suspected of biochemical recurrence. Previously, the group signed a product strategic cooperation agreement with Telix Pharmaceutical Limited (ASX: TLX; NASDAQ: TLX, collectively referred to as "Telix") in November 2020 and obtained exclusive rights for several innovative RDC products developed by Telix, including TLX591, TLX591-CDx, and TLX250-CDx, in the Greater China region (mainland China, Hong Kong, Macau, and Taiwan). TLX591-CDx is a global innovation, targeted radiopharmaceutical diagnostic drug based on radiolabeled small molecules that bind specifically to prostate-specific membrane antigen (PSMA), suitable for diagnosing primary and recurrent prostate cancer. Based on public data, the targeting agent PSMA-11 in TLX591-CDx can specifically bind with high affinity to PSMA that is highly expressed in prostate cancer cells, with five key characteristics: specific binding to PSMA, cellular internalization, biological activity stability, short circulating half-life, good tumor tissue penetration, and rapid clearance from non-target tissues. TLX591-CDx was approved for marketing in Australia in November 2021, in the United States in December 2021, in Canada in October 2022, and received expanded indications for screening prostate cancer patients eligible for PSMA targeted radiopharmaceutical therapy in the United States in March 2023. The product has also been approved for expanded indications in Australia and Canada in October 2024. As of 2025, TLX591-CDx has been commercialized in Austria, Belgium, Brazil, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, and the United Kingdom. The product achieved sales of approximately $517 million in 2024 and sales of approximately $461 million in the first three quarters of 2025, representing a growth of over 25% year-on-year. The group has established a comprehensive layout in the research and development, production, distribution, and sales of nuclear medicine for cancer diagnosis and treatment. With a global workforce of over 900 employees, research and development centers in Boston and Chengdu, production facilities in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries and regions, the group has achieved a global layout in the nuclear medicine industry. The group, in cooperation with Sirtex Medical Pty Ltd and in collaboration with Telix and ITM Isotope Technologies Munich SE (ITM SE), has built an international first-class tumor intervention research platform and RDC drug development platform. With the concept of integrated cancer diagnosis and treatment, the group has reserved 16 innovative products in the research and development registration stage, covering five radiopharmaceutical isotopes including 68Ga, 177Lu, 131I, 90Y, and 89Zr, targeting seven types of cancer including liver cancer, prostate cancer, and brain cancer. In the early stages of development, the group has over 10 RDC drug products in reserve. In terms of product categories, the group covers both diagnostic and therapeutic nuclear medicine, providing patients with a diverse range of treatment options and a leading global integrated cancer diagnosis and treatment strategy. The global research and development of innovative products within the segment is progressing smoothly. In China, Yttrium-90 microsphere injection (Embolyn) was successfully launched in January 2022 for the treatment of liver metastases from colorectal cancer, and in May 2025 received approval from the Chinese NMPA to conduct a Phase II registration clinical trial for treating inoperable HCC. The global innovative temperature-sensitive embolic agent GPN00289 completed enrollment of all patients for its registration clinical study in October 2025. In terms of international registrations, SIR-Spheres Yttrium-90 microsphere injection (Embolyn) was granted an early new indication approval in the United States in July 2025 for the treatment of inoperable HCC, making it the world's first and only selective internal radiotherapy product approved by the FDA for the dual indications of inoperable HCC and liver metastases from colorectal cancer; in September 2025, it obtained additional indications for several liver cancer indications from the European CE certification, further expanding its comprehensive coverage in the treatment of inoperable liver cancer, demonstrating the group's excellent overseas clinical registration and commercial operation capabilities, and providing important support for the product's expansion into liver cancer-related indications in China. In addition, the group is collaborating with experts from China and abroad to develop other indications for Yttrium-90 microsphere injection and will adopt an international registration pathway to accelerate the global market expansion of the product. Currently, the group has six innovative RDC products approved for registration clinical studies within the nuclear medicine for cancer diagnosis and treatment segment, with four entering Phase III clinical stages, 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 gastrointestinal and pancreatic neuroendocrine tumors (GEP-NETs). Recently, the group's self-developed global innovative small molecule RDC drug targeting fibroblast activation protein (FAP), GPN01530, received FDA approval to conduct a Phase I/II clinical study for diagnosing solid tumors, making it the group's first self-developed RDC product to receive FDA approval for clinical study. The successful approval of its clinical study sets an important paradigm for the international development of the group's nuclear medicine product pipeline and showcases the group's outstanding preclinical development and international registration capabilities, marking a significant milestone in the global research and registration process of the group's nuclear medicine for cancer diagnosis and treatment segment. The marketing application for ITM 11 submitted by the group's partner ITM SE in the United States has received formal acceptance by the FDA. Additionally, the global innovative radiopharmaceutical diagnostic drug GPN02006 targeting glypican-3 (GPC-3) based on radiolabeled antibody technology made a milestone breakthrough in a researcher-initiated clinical study (IIT clinical study) conducted in China, with an oral presentation at the 2025 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI). The product shows great potential and is expected to become the world's first radiopharmaceutical diagnostic RDC product targeting the GPC-3 receptor for hepatocellular carcinoma (HCC). As of now, the group has the highest number of diagnostic and therapeutic RDC innovative drugs in Phase III clinical studies in China, and is one of the most innovative drug enterprises globally with a rich product pipeline and comprehensive layout in nuclear medicine for cancer diagnosis and treatment. The group's radiation drug research and production base in Wenchuan District, Chengdu, Sichuan Province, China, was completed and approved in April 2025, and obtained a Class A "Radiation Safety Permit" from the National Ministry of Ecology and Environment in May, and officially started operations at the end of June. The base is the world's first closed-loop platform for nuclear medicine, covering the full chain of "isotope preparation - nuclear medicine research - clinical production - commercialization," establishing a full life cycle management capability from early research to clinical transformation to market sales, with international leading research and development efficiency; solving the bottleneck issue of nuclear medicine, achieving 100% independent production to break through import dependence, with 14 high-standard GMP production lines meeting the demand for multiple varieties and large-scale preparation; establishing a full-process intelligent management system, nuclear power-level safety and unmanned intelligent manufacturing to achieve "zero leakage" of radiation, "zero discharge" of pollution, and "zero exceeding limit" of occupational exposure, meeting the highest global standards for nuclear facilities; establishing world-class research and production quality and operation system, making it one of the most complete in terms of types of isotopes and highest degree of automation among smart factories currently in operation internationally. The research and production base will further consolidate the foundation of the group's nuclear medicine industry, accelerate the landing of the global innovative research and development pipeline, promote the high-quality development of the group's nuclear medicine industry, cultivate high-value blockbuster products, and lay a solid foundation for the domestic production of the group's radiopharmaceuticals. In the future, the group will continue to strengthen the research and construction of the nuclear medicine for cancer diagnosis and treatment segment, enrich and improve the product pipeline and industry layout, form a cluster of nuclear medicine for cancer diagnosis and treatment products centered around Yttrium-90 microsphere injection (Embolyn), and continue to solidify the group's leading position as a global leader in the field of nuclear medicine for cancer diagnosis and treatment. The group has always attached great importance to the research and development of innovative products and advanced technologies, with a focus on patient needs and driven by technological innovation. To address unmet clinical needs, the group has increased investment in global innovative products and advanced technologies, enriched and improved the product pipeline and industry layout, and adopted a strategy of "globalized operation layout, dual-cycle operation development," forming a new pattern of coordinated development between domestic and international cycles, fully leveraging the group's industrial advantages and research and development capabilities, rapidly bringing technological innovative products to market, providing more advanced and diverse treatment options for patients worldwide.