GRAND PHARMA (00512) has received Fast Track designation from the FDA for its independently developed global innovative radiolabeled conjugate drug GPN01530-2.

GRAND PHARMA (00512) announced that its self-developed globally innovative radioactive nuclide conjugate drug (RDC) GPN01530-2, designed for the diagnosis of solid tumors, has recently received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). The FDA has established the Fast Track mechanism to expedite and facilitate the review of new drugs intended for the treatment of serious or life-threatening diseases for which there are no effective treatment options currently available, and that demonstrate potential to meet the unmet medical needs for these conditions. Candidates granted Fast Track status may qualify for more frequent communication with the FDA, prioritized review (if relevant criteria are met), and rolling review for new drug applications, thereby accelerating the development and market introduction of the relevant drugs. Previously, GPN01530-2 had received FDA approval to conduct Phase I/II clinical trials for the diagnosis of solid tumors. Successfully obtaining FTD qualification marks an important milestone in the groups global R&D and registration layout for nuclear medicines anti-tumor treatment sector, fully confirming the groups comprehensive strength in constructing advanced nuclear medicine technology platforms, international clinical development, and registration applications. The group will rely on "dual submission" registration pathways in China and the U.S. to continue advancing global R&D and registration for GPN01530-2, and based on this, further deepen the globalization development strategy of this sector, actively promoting more internationally registered clinical research for self-developed innovative nuclear medicine products, and continually enhancing the group's core competitiveness and international influence in the field of nuclear medicine anti-tumor treatment. GPN01530-2 is a small molecule RDC drug that targets fibroblast activation protein (FAP). FAP is one of the important markers for cancer-associated fibroblasts (CAFs), participating in processes such as extracellular matrix remodeling, regulation of tumor cell proliferation, and tumor immune suppression, thereby facilitating tumor invasion. Research indicates that FAP is not expressed or is expressed at low levels in normal tissues, but is highly expressed in 90% of epithelial tumor tissues and various tumor microenvironments of CAFs. The specific targeting of FAP by GPN01530-2 provides new diagnostic possibilities for various malignant tumors. Currently, the clinically commonly used PET/CT imaging agent is fluorine-18-deoxyglucose (18F-FDG), which assesses diseases by determining the level of glucose metabolism in lesions, but its sensitivity is relatively low (40%-68%), limiting its value in early tumor diagnosis. In contrast, imaging agents targeting FAP possess broad applicability to solid tumors and high sensitivity and have become a popular target in radioactive drug research. The GPN01530-2 developed by the group optimized the structure of the FAP ligand, improving its uptake in tumor tissues while reducing its uptake in normal tissues. Preclinical studies have shown that this product exhibits rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic characteristics compared to other FAP ligands. Furthermore, ongoing investigator-initiated human studies have demonstrated that this product has good safety, rapid background clearance, and strong and long-lasting lesion uptake, showing better clinical image contrast and accurate detection rate of positive lesions compared to 18F-FDG. Based on existing preclinical and clinical research results, this product significantly enhances the diagnostic efficacy of FAP-targeted RDC drugs and is expected to provide a new diagnostic solution for a large number of solid tumor patients. The early research on the GPN01530-2 project was accomplished independently at the groups nuclear medicine base in Chengdu, utilizing its radiochemical labeling and animal molecular imaging platforms, completing the labeling process development and animal imaging studies. It also achieved the production and inspection release of the registration batch through a production line compliant with Good Manufacturing Practice (GMP). This project is the first self-developed product from the Chengdu nuclear medicine base to enter the FDA clinical stage since it became operational, demonstrating the excellent preclinical development and international registration capabilities of this technology platform. Cancer is one of the leading causes of death worldwide. According to GLOBOCAN data, in 2022 there were approximately 20 million new cases of cancer globally and about 9.7 million deaths, with predictions suggesting nearly 24 million new cases and around 12 million deaths by 2030. In the foreseeable future, cancer will remain a significant public health issue threatening human health. It is widely recognized that precise diagnosis and treatment play a crucial role in cancer prognosis, leading to radioactive drugs with integrated diagnostic and therapeutic potential becoming a hot research area. Statistics indicate that the global radioactive drug market size has grown from $5 billion in 2018 to $9.7 billion in 2024, with a compound annual growth rate of 11.7%. It is projected to rise to $57.3 billion by 2035, with a compound annual growth rate of 17.5% between 2024 and 2035. In the Chinese market during the same period, the scale is expected to increase from RMB 3.6 billion in 2018 to RMB 7.4 billion in 2024, with a compound annual growth rate of 13.0%. By 2035, it is predicted to reach RMB 75.8 billion, with a compound annual growth rate of 23.5% from 2024 to 2035. The continuous advancement of imaging technologies and radioactive ligand therapies, along with an aging population, will sustain high growth momentum in the radioactive drug market. If GPN01530-2 develops smoothly, this product is expected to become a significant breakthrough in addressing the challenges of solid tumor diagnosis, reshaping the diagnostic landscape with its substantial product advantages, securing a leading global market position, and bringing new hope to patients worldwide. The group has achieved a comprehensive layout encompassing R&D, production, distribution, and sales in the nuclear medicine anti-tumor treatment sector, employing over 1,000 staff globally, with R&D bases centered in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, as well as a sales network covering more than 50 countries and regions, establishing a globally integrated nuclear medicine industry chain. The group has established a tumor intervention R&D platform and an RDC drug R&D platform with international first-class standards. Currently, 16 innovative products have been reserved in the R&D registration phase, covering five radioactive nuclides, including 68Ga, 177Lu, 131I, 90Y, and 89Zr, addressing seven cancer types including liver cancer, prostate cancer, and brain cancer. In the early R&D phase, RDC drugs are prioritized, with over ten products in reserve. Regarding product types, the portfolio includes both diagnostic and therapeutic nuclide drugs, providing patients with multi-indication treatment options and global leading anti-tumor solutions with integrated diagnosis and treatment. The global R&D work on innovative products within the sector is progressing smoothly. In China, Ygantai Yttrium-90 microsphere injection debuted successfully in January 2022 for treating colorectal cancer liver metastasis and was approved by the Chinese National Medical Products Administration in May 2025 to proceed with a Phase II registration clinical trial for treating unresectable HCC; the globally innovative temperature-sensitive embolic agent GPN00289 completed patient enrollment for its registration clinical study by October 2025. Regarding overseas registration, SIR-Spheres Yttrium-90 microsphere injection received early formal FDA approval in July 2025 for a new indication to treat unresectable HCC, marking it as the world's first and only FDA-approved selective internal radiation therapy product for both unresectable HCC and colorectal cancer liver metastasis indications; in August 2025, it obtained European CE mark certification for additional liver cancer indications, further promoting comprehensive coverage of this product in the treatment of unresectable liver cancer, resulting in strategic market expansion; additionally, the group is collaborating with experts both domestically and internationally to develop other indications for Yttrium-90 microsphere injection, employing a "dual submission" international registration path to accelerate the product's global market expansion. Currently, the group has six innovative RDC drugs approved for registration clinical research in the nuclear medicine anti-tumor treatment sector, where one has entered the NDA stage, and three have entered Phase III clinical stages, including 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 groups globally innovative diagnostic radioactive drug targeting glypican-3 (GPC-3) based on radioactive nuclide-antibody conjugation technology, GPN02006, achieved a milestone breakthrough in investigator-initiated clinical research (IIT) conducted in China and won a verbal report at the SNMMI annual meeting in North America in 2025, showcasing its potential to be the worlds first RDC product targeting the GPC-3 marker for hepatocellular carcinoma (HCC) diagnosis. The GRAND PHARMA radioactive drug R&D and production base located in Wenjiang District, Chengdu, Sichuan Province, China, completed acceptance in April 2025, received a top-level "Radiation Safety License" from the Ministry of Ecology and Environment in May, and officially commenced operations at the end of June. This base is the worlds first closed-loop platform for the entire nuclear medicine industry chain, covering the full range from "isotope preparation - nuclear medicine R&D - production and clinical application - commercialization," forming a full lifecycle management capability from early R&D to clinical translation to market sale, achieving industry-leading R&D efficiency; it addresses the "bottleneck" problem in nuclear medicine, enabling 100% domestic production to resolve reliance on imports with 14 high-standard GMP production lines to meet the needs for multiple varieties and large-scale production; establishing a full-process intelligent management system, nuclear-grade safety, and unmanned intelligent manufacturing, achieving "zero leakage" of radiation, "zero discharge" of pollution, and "zero exceedance" of occupational exposure, reaching global top nuclear facility standards; it has established a world-class quality and operational system for R&D and production, making it one of the most automated smart factories with the most comprehensive range of nuclides internationally. This R&D and production base will further strengthen the foundation of the groups nuclear medicine industry, accelerate the implementation of the global innovative R&D pipeline, promote high-quality development of the nuclear medicine industry, cultivate high-value flagship products, and lay a solid foundation for the localization of the groups radioactive drugs. In the future, the group will continue to enhance R&D and construction in the nuclear medicine anti-tumor treatment sector, enrich and perfect its product pipeline and industrial layout, forming a cluster of nuclear medicine anti-tumor treatment products centered around Ygantai Yttrium-90 microsphere injection, further solidifying the groups position as a leading enterprise in the global nuclear medicine anti-tumor treatment field. The group has always placed significant emphasis on the R&D of innovative products and advanced technologies, centering on patient needs and driving technological innovation. In response to unmet clinical needs, it has increased investment in global innovative products and advanced technologies, enriching and refining its product pipeline and industrial layout. Adopting a strategy of "global operational layout with dual circulation development," a new pattern is being formed where domestic and international dual circulation develops in tandem and promotes each other. This strategy will fully leverage the groups industrial advantages and R&D strength, rapidly bringing tech-innovative products to market, thereby providing global patients with more advanced and diversified treatment options.