GRAND PHARMA (00512) announced that its independently developed global first-in-class, investigational radioactive drug conjugate (RDC) for diagnosing solid tumors, GPN01530-2, has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). The FDA's Fast Track program is designed to facilitate and expedite the review of new drugs intended to treat serious or life-threatening conditions with no current effective treatment, where preclinical or clinical data demonstrates the potential to address unmet medical needs. A candidate granted FTD may benefit from more frequent FDA interactions, priority review (if criteria are met), and rolling review of the New Drug Application, thereby accelerating the drug's development and market entry.
Previously, GPN01530-2 had already received FDA clearance to initiate Phase I/II clinical studies for diagnosing solid tumors. This successful FTD achievement marks a significant milestone in the global research and registration strategy for the company's nuclear medicine oncology pipeline, strongly validating its comprehensive capabilities in cutting-edge radiopharmaceutical technology platforms, international clinical development, and regulatory submissions. Leveraging a dual-filing international registration pathway covering both China and the U.S., the company will continue to advance the global development and registration of GPN01530-2, further deepening its global expansion strategy in this segment. It will actively promote the international clinical research and registration of more independently developed innovative radiopharmaceutical products, aiming to enhance its core competitiveness and international influence in the field of radiopharmaceutical-based oncology.
GPN01530-2 is a small-molecule RDC targeting fibroblast activation protein (FAP). FAP is a key marker of cancer-associated fibroblasts (CAFs) and is involved in processes such as extracellular matrix remodeling, regulating tumor cell proliferation, and tumor immune suppression, which promote tumor growth and invasion. It has emerged as a novel, specific target for tumor diagnosis and therapy. Studies indicate that FAP expression is absent or low in normal tissues but is highly expressed in over 90% of epithelial tumors and in CAFs within the tumor microenvironment. By specifically targeting FAP, GPN01530-2 opens new possibilities for diagnosing a wide range of malignant tumors.
The most commonly used PET/CT imaging agent in clinical practice is fludeoxyglucose F-18 (18F-FDG), which assesses disease based on the level of glucose metabolism in lesions. However, its sensitivity is relatively low (40%~68%), limiting its value in early tumor diagnosis. In contrast, FAP-targeted imaging agents hold promise for pan-solid tumor applications with high sensitivity, making them a hot topic in radiopharmaceutical research. The independently developed GPN01530-2 features an optimized FAP ligand structure that enhances tumor uptake while reducing uptake in normal tissues. Preclinical results show that compared to other FAP ligands, GPN01530-2 exhibits rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties. Furthermore, in already conducted investigator-initiated trials (IIT) in humans, the product has demonstrated a good safety profile, rapid background clearance, and strong, persistent lesion uptake. Compared to 18F-FDG, it shows better clinical image contrast and a higher accurate detection rate of positive lesions. Based on existing preclinical and clinical results, this product significantly improves the diagnostic performance of FAP-targeted RDCs and is expected to offer a novel tumor diagnostic solution for a broad range of solid tumor patients.
The early-stage research for the GPN01530-2 project was fully and independently completed by the company's radiochemistry platform and animal molecular imaging platform at its Chengdu nuclear medicine base. This included the one-stop development of labeling processes and animal imaging studies. The project also utilized the base's GMP-compliant production line to produce registration batches and complete release testing. This project is the first independently developed product from the Chengdu nuclear medicine base to enter the FDA clinical stage since its operation, demonstrating the strong preclinical development and international registration capabilities of this technology platform.
Cancer remains a leading cause of death worldwide. According to GLOBOCAN data, there were approximately 20 million new cancer cases and 9.7 million deaths globally in 2022. Forecasts predict close to 24 million new cases and nearly 12 million deaths by 2030. For the foreseeable future, cancer will remain a major public health issue threatening human health. Currently, it is widely recognized that precise diagnosis and treatment are crucial for cancer prognosis. Therefore, radiopharmaceuticals with theranostic potential have become a hot area of research. According to statistics, the global radiopharmaceutical market grew from USD 5.0 billion in 2018 to USD 9.7 billion in 2024, with a compound annual growth rate (CAGR) of 11.7%. It is projected to climb to USD 57.3 billion by 2035, representing a CAGR of 17.5% from 2024 to 2035. During the same period, the Chinese market grew from RMB 3.6 billion in 2018 to RMB 7.4 billion in 2024, a CAGR of 13.0%, and is expected to reach RMB 75.8 billion by 2035, with a CAGR of 23.5% from 2024 to 2035. Driven by continuous advancements in imaging technology and radioligand therapy, coupled with an aging population, the radiopharmaceutical market is expected to maintain high growth momentum. If GPN01530-2's development proceeds smoothly, the product could become a key breakthrough in solving the diagnostic dilemma for solid tumors, reshaping the diagnostic landscape with its significant product advantages, securing a leading global market position, and bringing new hope to patients worldwide.
The company has established a comprehensive layout in the nuclear medicine oncology segment, covering research, production, distribution, and sales. With over 1,000 employees globally, the company's operations are underpinned by R&D centers in Boston and Chengdu; manufacturing bases in Boston, Frankfurt, Singapore, and Chengdu; and a sales network spanning over 50 countries and regions, achieving a globalized radiopharmaceutical industry chain. The company has built internationally competitive tumor interventional therapy and RDC drug research platforms. Focusing on the concept of integrated diagnosis and therapy, the company currently has 16 innovative products in the research and registration stage, covering 5 types of radionuclides (including 68Ga, 177Lu, 131I, 90Y, and 89Zr) and targeting 7 cancer types including liver cancer, prostate cancer, and brain cancer. The early-stage R&D pipeline is mainly focused on RDC drugs, with over 10 products in reserve. The product portfolio includes both diagnostic and therapeutic radionuclide drugs, offering patients multiple treatment options across various indications and a leading global anti-tumor solution incorporating integrated diagnosis and therapy.
The global development of innovative products within the segment is progressing smoothly. In China, the SIR-Spheres® Y-90 microspheres injection was successfully launched in January 2022 for treating colorectal cancer liver metastases. In May 2025, the China National Medical Products Administration (NMPA) approved a Phase II registrational clinical trial for the product in treating unresectable HCC. The global innovative temperature-sensitive embolic agent GPN00289 completed enrollment of all patients for its registrational clinical study in October 2025. Regarding overseas registrations, the SIR-Spheres® Y-90 microspheres injection received an early formal FDA approval for a new indication in July 2025 for treating unresectable HCC, making it the first and only selective internal radiation therapy (SIRT) product globally with FDA approval for both unresectable HCC and colorectal cancer liver metastases. In August 2025, it received CE Mark certification in Europe for additional liver cancer indications, further expanding its coverage in the treatment of unresectable liver cancer and achieving a strategic expansion of market potential. Additionally, the company is collaborating with Chinese and international experts to develop other indications for the Y-90 microspheres injection, using a dual-filing international registration pathway to accelerate the product's global market expansion.
Currently, the company has six innovative RDC products in the nuclear medicine oncology segment approved for registrational clinical studies, with one in the NDA stage and three in Phase III clinical trials. These include TLX591 CDx for diagnosing prostate cancer, TLX591 for treating prostate cancer, TLX250-CDx for diagnosing clear cell renal cell carcinoma, and ITM-11 for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The company's global innovative, radionuclide-antibody-conjugate-based diagnostic radiopharmaceutical targeting glypican-3 (GPC-3), GPN02006, achieved a landmark breakthrough in an investigator-initiated clinical study (IIT) in China and was presented as an oral presentation at the 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. This product holds significant potential to become the world's first diagnostic RDC product targeting GPC-3 for hepatocellular carcinoma (HCC).
The company's radiopharmaceutical R&D and manufacturing base located in Wenjiang District, Chengdu, Sichuan Province, China, completed construction acceptance in April 2025, received 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 closed-loop platform for the entire radiopharmaceutical industry chain, covering "isotope preparation - radiopharmaceutical R&D - clinical production - commercialization." It provides full lifecycle management capabilities from early-stage R&D to clinical translation and market launch, with internationally leading R&D efficiency. The base solves the "bottleneck" problem in radiopharmaceuticals by achieving 100% independent production, breaking the reliance on imports. It features 14 high-standard GMP production lines capable of multi-product, large-scale manufacturing. The facility establishes a comprehensive intelligent management system, with nuclear power-grade safety and unmanned intelligent manufacturing, aiming for "zero radiation leakage," "zero external pollution," and "zero occupational exposure exceedance," meeting top-tier global nuclear facility standards. It is one of the world's most advanced smart factories regarding the variety of radionuclides handled and the level of automation. This R&D and manufacturing base will further strengthen the company's foundation in the radiopharmaceutical industry, accelerate the realization of its global innovative R&D pipeline, drive high-quality development in the radiopharmaceutical segment, and cultivate high-value, blockbuster products, laying a solid foundation for the domestic localization of the company's radiopharmaceuticals. Looking ahead, the company will continue to strengthen the R&D and construction of its nuclear medicine oncology segment, enrich and refine its product pipeline and industrial layout, and form a cluster of nuclear medicine oncology products centered around SIR-Spheres® Y-90 microspheres injection, continuously consolidating its leading position in the global nuclear medicine oncology field. The company consistently prioritizes the R&D of innovative products and advanced technologies. Driven by patient needs and technological innovation, it will increase investment in global innovation and advanced technologies to address unmet clinical needs, enrich its product pipeline and industrial layout, and adopt a strategy of "globalized operations and dual-cycle business development." This creates a new pattern of mutually reinforcing domestic and international dual-cycle development, fully leveraging the company's industrial advantages and R&D capabilities, to rapidly bring innovative technological products to market and provide patients worldwide with more advanced and diverse treatment options.
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