Breakthrough FAP target technology bottleneck! GRAND PHARMA (00512) independently developed innovative RDC in the United States has obtained FDA approval and is aiming at the multi-billion dollar oncology drug market.

Heavy positive news came from the leader in nuclear medicine! Recently, GRAND PHARMA (00512) received official approval from the U.S. FDA to conduct Phase I/II clinical trials for its globally innovative FAP target radioisotope-linked drug (RDC) GPN01530 for diagnosing solid tumors. It is reported that GPN01530 is GRAND PHARMA's first self-developed RDC product to receive FDA approval for clinical trials. This clinical approval marks an important milestone in GRAND PHARMA's "Go Global" strategy, not only providing an important paradigm for the international development of its nuclear medicine product pipeline, but also showcasing the company's comprehensive strength in cutting-edge nuclear medicine technology platform construction, international clinical development, and registration applications. At the same time, GPN01530 is expected to provide a significant example of China's innovative drugs entering the global market with its Best-in-Class (BIC) potential. Optimizing FAP ligand structure to address technological bottlenecks, enhancing market competitiveness in pan-cancer diagnosis FAP (fibroblast activation protein) is an important marker of cancer-associated fibroblasts (CAFs) involved in processes such as extracellular matrix remodeling, regulation of tumor cell proliferation, tumor immune suppression, promoting tumor invasion and metastasis, and is a new type of specific target for cancer diagnosis and treatment. Studies have shown that FAP is not expressed or expressed at low levels in normal tissues, but highly expressed in 90% of epithelial tumors and various tumor microenvironments containing CAFs. In terms of cancer diagnosis, compared to the commonly used PET/CT imaging agent fluorine [18F]-fluorodeoxyglucose (18F-FDG), imaging agents targeting FAP have the advantages of broader applicability in solid tumors and higher sensitivity, with detection sensitivities reaching 80%-90% in gastric cancer, colorectal cancer, and liver cancer, significantly higher than the 40%-68% sensitivity of 18F-FDG. The clinical application potential of FAP targets in cancer diagnosis and treatment has become an industry consensus, and the research and development of radioactive drugs targeting this target is accelerating from early stage research to clinical research. Leveraging its research and development technology in the field of nuclear medicine, GRAND PHARMA innovatively optimized the structure of the FAP ligandcompany GPN01530 increased uptake in tumor tissues while reducing uptake in normal tissues. Preclinical studies have shown that compared to other FAP ligands, GPN01530 demonstrates rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties. Furthermore, early human studies in which IIT was conducted showed that this product has good safety, rapid clearance from background, strong and sustained uptake in lesions, and better clinical image contrast and accurate detection rate of positive lesions compared to 18F-FDG. Based on existing preclinical and clinical research results, GPN01530 significantly enhances the diagnostic efficacy of RDC drugs targeting the FAP target. GPN01530 is expected to break through the technological bottleneck of current FAP target RDC drugs, or provide a new tumor diagnostic solution for a large number of solid tumor patients, representing a drug with significant BIC potential. Based on the FAP target, GPN01530 may have the potential to achieve "pan-cancer" clinical applications in the future, expanding to other common cancers such as gastric cancer, thereby enhancing its market competitiveness. According to GLOBOCAN data, there are approximately 20 million new cancer cases worldwide in 2022, with around 9.7 million deaths, and it is estimated that new cancer cases will reach close to 24 million and deaths will reach close to 12 million by 2030. In terms of market size, the global oncology drug market has grown from $150.3 billion in 2020 to $253.3 billion in 2024, with a compound annual growth rate of 13.9%, and is projected to grow at a compound annual growth rate of 10.2% to reach $452.5 billion by 2030, indicating a huge market space for cancer diagnostics and treatments. In the future, if the development of GPN01530 progresses smoothly, this product may become an important breakthrough in solving the dilemma of solid tumor diagnosis and treatment, reshaping the landscape of solid tumor diagnosis and treatment with its high specificity and integrated diagnosis and treatment advantages, bringing new hope to global patients. In addition, based on this product, GRAND PHARMA will further advance international clinical research and registration applications for more innovative self-developed products, continuously enhancing the company's global core competitiveness in the field of nuclear medicine. The Go Global strategy provides a sustainable template for international expansion, continuously consolidating global nuclear medicine competitiveness The successful internationalization of GPN01530 coincides with the outbreak period of the global nuclear medicine industry. Data shows that the global radiopharmaceuticals market is estimated to reach around $9.7 billion by 2024 and is expected to climb to $57.3 billion by 2035, with a compound annual growth rate of about 17.5%. In China, this market is projected to increase from RMB 7.4 billion in 2024 to RMB 75.8 billion in 2035, with a compound annual growth rate of 23.5%. The continuous progress in imaging technology and radioisotope therapy, coupled with the aging population, will drive the radiopharmaceuticals market to continue its rapid growth. GRAND PHARMA's forward-looking layout in this field has established a clear first-mover advantage, not only boasting a rich and globally leading product portfolio, but also achieving a comprehensive layout in various aspects of the industry chain such as research and development, production, distribution, and sales. With research bases in Boston and Chengdu as cores, production bases in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering more than 50 countries and regions, the company has achieved a global nuclear medicine industry chain layout. In terms of product pipeline, GRAND PHARMA has the highest number of RDC innovative drugs for diagnosis and treatment in Phase III clinical trials in China, as well as one of the most extensive product pipelines and integrated diagnostics and treatment layouts in the global nuclear medicine anti-tumor field. Currently, the company has 16 innovative products in the development and registration phase, covering five radioactive isotopes including 68Ga, 177Lu, 131I, 90Y, 89Zr, and seven types of cancers including liver cancer, prostate cancer, and brain cancer; with more than 10 RDC drugs in the early research and development stages. In terms of product categories, it covers both diagnostic and therapeutic nuclear medicine drugs, providing patients with multiple indications for treatment, and a global leading integrated anti-tumor solution. With the advantage of its forward-looking layout, GRAND PHARMA has successfully demonstrated the clinical value of nuclear medicine treatment products in China. In 2024, the company's SIR-Spheres yttrium [90Y] microsphere injection (YiGanTai) experienced rapid growth, driving the nuclear medicine anti-tumor diagnosis and treatment sector to achieve over 170% year-on-year growth. In addition, the company's overseas nuclear medicine research and development has also progressed smoothly, with its innovative RDC product ITM-11 for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) having its U.S. market application accepted by the FDA. In terms of industrial layout, GRAND PHARMA has built the world's first closed-loop platform for the nuclear medicine industry, creating a closed-loop system that covers the entire industry chain, truly achieving full autonomous control of the research and development, production, and sales of innovative nuclear medicine products. The company's radiation medicine research and production base in Wenjiang, Chengdu, was awarded a Class A "Radiation Safety Permit" by the Ministry of Ecology and Environment in May 2025, and officially commenced operations in June of the same year. It is currently one of the most comprehensive and automated intelligent factories in the international arena, fully meeting the diverse and large-scale preparation needs of GRAND PHARMA's therapeutic and diagnostic nuclear medicine products. It is worth noting that the early research of the GPN01530 project was based on GRAND PHARMA's independent completion of the labeling process and animal imaging research through its radiolabeling platform and animal molecular imaging platform at its nuclear medicine base in Chengdu. This platform also relied on GMP production lines to achieve the production and testing release of registered batches. At the same time, GPN01530 is the first self-developed product from GRAND PHARMA's Chengdu nuclear medicine base to enter the FDA clinical stage since its operation in June this year, demonstrating the outstanding pre-clinical development and international registration capabilities of this technology platform. GRAND PHARMA's global layout in the nuclear medicine industry is a concentrated demonstration of the deepening of the company's "Go Global" strategy, and the implementation of this strategy is reshaping the global narrative of Chinese innovative drugs, providing a sustainable benchmark path for domestic pharmaceutical companies. With the support of the international registration path of "dual filing" in China and the U.S., GRAND PHARMA will firmly grasp the global market value of innovative drugs, continuously strengthen the company's core competitiveness in the field of nuclear medicine. In the future, with the successful development of innovative products such as GPN01530 and the continued deepening of the nuclear medicine industry layout, GRAND PHARMA will continue to advance towards becoming the world's first nuclear medicine MNC.