China's FAP-targeted nuclear medicine for the diagnosis of solid tumors has received FDA fast track designation for the first time. GRAND PHARMA (00512) has developed a product that directly addresses the unmet market demand of over a hundred billion dollars for general solid tumors.

As radioactive drugs become a popular avenue for innovation in oncology globally, FAP-targeting assets, which possess both diagnostic and therapeutic potential, have become the focus of competition among pharmaceutical companies worldwide. As a leader in nuclear medicine, GRAND PHARMA (00512) recently achieved a significant breakthrough in this field. The companys innovative nuclear drug GPN01530-2, targeting FAP, has been granted Fast Track Designation (FTD) by the U.S. FDA, becoming the worlds first nuclear drug for the diagnosis of solid tumors with FDA fast-track recognition targeting the FAP pathway. FTD is primarily awarded to investigational drugs intended to treat serious conditions that demonstrate the potential to address unmet medical needs, aiming to accelerate the review process of high-value pipelines. It is reported that GPN01530-2 had previously received FDA approval to conduct Phase I/II clinical studies for diagnosing solid tumors. The recent designation of FTD marks recognition from American regulatory bodies of the product's significant potential in solid tumor diagnostics, which may expedite the future development and market launch of GPN01530-2, benefiting global patients sooner. Notably, the acquisition of the FTD designation by GPN01530-2 holds considerable significance within the industry; against the backdrop of major global nuclear medicine companies aggressively investing in FAP-targeted nuclear drugs, an innovative nuclear drug developed independently by a Chinese enterprise securing this crucial regulatory qualification demonstrates GRAND PHARMA's research capabilities in FAP-targeting nuclear medicine, placing it among the top tier globally. It also reflects the best-in-class (BIC) development potential of GPN01530-2. Furthermore, as a self-developed product from GRAND PHARMA that has received FDA approval for clinical studies, this milestone also substantiates the company's comprehensive strength in cutting-edge nuclear medicine technology platform development, international clinical trials, and regulatory applications. Optimizing the FAP Ligand Structure to Unlock the Vast Market Potential of Solid Tumors According to the announcement, GPN01530-2 is a small-molecule radioactive drug targeting fibroblast activation protein (FAP), which is not expressed or is expressed at low levels in normal tissues but is highly expressed in 90% of epithelial tumors and in tumor-associated fibroblasts (CAFs) in various tumor microenvironments, making it a novel specific target for cancer diagnosis and treatment. The specific expression characteristics of FAP make it an ideal target for pan-cancer diagnosis and treatment, potentially covering various solid tumors including lung cancer, colorectal cancer, pancreatic cancer, etc. The intrinsic compatibility with "diagnosis + treatment" integrated RDC drug development is viewed by the industry as a billion-dollar target with significant imaginative space, attracting major multinational pharmaceutical companies such as Novartis to stake claims. Notably, GRAND PHARMA has improved GPN01530-2 by optimizing the structure of the FAP ligand, enhancing its uptake in tumor tissues while reducing its uptake in normal tissue. Compared with similar FAP-targeted products and currently mainstream PET/CT imaging agent fluorine-18-fluorodeoxyglucose (18F-FDG), GPN01530-2 demonstrates significant advantages, showcasing strong best-in-class potential. Based on existing research results, GPN01530-2 shows faster tumor targeting, higher tumor uptake, and superior pharmacokinetic properties relative to other FAP ligands. Additionally, completed IIT human studies indicate that GPN01530-2 exhibits rapid background clearance, strong and sustained lesion uptake, with better clinical image contrast and higher accuracy in detecting positive lesions compared to 18F-FDG. It is evident that GPN01530-2 significantly enhances the diagnostic efficacy of FAP-targeting RDC drugs and is expected to provide a new cancer diagnosis solution for a wide range of solid tumor patients. From a market perspective, GPN01530-2 represents a product with substantial commercialization potential; merely estimating its replacement market for 18F-FDG indicates a potential market space exceeding $5 billion, with the patient population it targets continually growing. According to GLOBOCAN data, in 2022, there were approximately 20 million new cancer cases globally and around 9.7 million deaths, with projections indicating that by 2030, new cancer cases will approach 24 million and deaths will nearly reach 12 million. As the patient population grows, the global oncology drug market is also on the rise, with Frost & Sullivan estimating that the global oncology drug market will reach $702.7 billion by 2035. In this large and continually expanding cancer diagnosis and treatment market, precise, efficient, and safe integrated diagnostic and therapeutic solutions have become a core need for the industry, creating excellent competitive opportunities for GPN01530-2. Currently, GPN01530-2 has been approved to conduct clinical research in the United States. If subsequent development proceeds smoothly, it could become an important breakthrough in resolving diagnostic challenges for solid tumors. Additionally, leveraging the specialized policy benefits of the FTD, this product is expected to shorten development and market launch timelines, reshaping the diagnostic landscape for solid tumors with its significant product advantages and being the first to capture the global solid tumor diagnostic market, bringing new hope to patients worldwide. Furthermore, as the world's first and currently the only FAP-targeted nuclear drug for solid tumors to obtain FTD recognition, the substantial clinical value and BIC development potential of GPN01530-2 have been recognized by authoritative regulatory agencies, marking a breakthrough where Chinese innovative nuclear drugs have achieved global leadership, synchronized standards, and prioritized benefits in the cutting-edge FAP-targeted nuclear drug field. GRAND PHARMA will also rely on the dual registration strategy in both China and the U.S. to continue advancing the global development and registration of GPN01530-2 and, based on this, further deepen the globalization development strategy of the nuclear medicine oncology sector, actively promoting international clinical research and registration applications for more independently developed innovative nuclear drug products, continually enhancing the companys core competencies and international influence in the field of nuclear medicine cancer diagnosis and treatment. Building a Complete Nuclear Medicine Industry Ecosystem, Aiming for Global Export of Chinese Self-Developed Products The overseas clinical breakthrough of GPN01530-2 is a reflection of the implementation of GRAND PHARMA's globalization strategy in the nuclear medicine oncology sector. As one of the earliest domestic innovative pharmaceutical companies to layout the entire nuclear medicine industry chain, GRAND PHARMA has established comprehensive arrangements in R&D, production, distribution, and sales within this sector. The company has now built a global nuclear medicine industry chain, establishing R&D bases centered in Boston and Chengdu, with production bases in Boston, Frankfurt, Singapore, and Chengdu, along with a sales network covering over 50 countries and regions, employing more than a thousand researchers and industry personnel worldwide. In terms of its product pipeline, GRAND PHARMA, centered around the integrated concept of cancer diagnosis and treatment, has accumulated 16 innovative nuclear drug products in the R&D registration phase, encompassing five types of radioactive isotopes including 68Ga, 177Lu, 131I, 90Y, and 89Zr, targeting seven types of cancers including liver cancer, prostate cancer, and brain cancer. Early-stage R&D is primarily focused on RDC drugs, with over 10 products in the pipeline that encompass both diagnostic and therapeutic categories, offering multiple treatment options and globally leading integrated diagnostic and therapeutic solutions for patients. Aiming at the global market, GRAND PHARMA is systematically advancing the clinical research and commercialization of nuclear medicine products. In China, as the sales of Yttrium-90 microsphere injection () continuously increase, the companys product TLX591-CDx for diagnosing prostate cancer has entered the NDA stage. Internationally, GRAND PHARMA's SIR-Spheres Yttrium-90 microsphere injection has received early FDA approval in July 2025 for a new indication for the treatment of unresectable hepatocellular carcinoma (HCC), becoming the worlds first and only selective internal radiation therapy product approved by the FDA for dual indications of unresectable HCC and colorectal cancer liver metastasis. In August of the same year, it received European CE mark certification for additional indications in liver cancer, further promoting comprehensive coverage in the treatment of unresectable liver cancer and achieving strategic market space expansion. The company is also collaborating with domestic and foreign experts to develop additional indications for the Yttrium-90 microsphere injection and will utilize the dual registration international approach to expedite the global market expansion of this product. Moreover, international conferences further validate GRAND PHARMA's global R&D level, with the research outcomes of GRAND PHARMA's innovative targeted phosphatidylinositol glycan class protein 3 (GPC-3) diagnostic radioactive drug GPN02006 winning a presentation slot at the 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, with the product expected to become the worlds first diagnostic RDC product targeting the GPC-3 for hepatocellular carcinoma (HCC). In terms of production, GRAND PHARMA's Chengdu Wenjiang radioactive drug R&D and production base is set to be fully operational by 2025, as the worlds first closed-loop platform for the entire nuclear drug industry chain. This base is recognized as one of the most comprehensive in terms of the types of isotopes and has the highest level of automation among intelligent factories internationally, covering the entire chain from "isotope preparation - nuclear drug R&D - clinical production - commercialization." The base's 14 high-standard GMP production lines meet diverse and large-scale preparation demands, resolving the "bottleneck" issues faced by nuclear drugs, achieving 100% self-sufficient production, eliminating dependency on imports, and further reinforcing GRAND PHARMAs nuclear medicine industry foundation. This accelerates the realization of high-quality development in the nuclear medicine industry, cultivates high-value products, and lays a solid foundation for the localization of radioactive drugs. Looking at the global nuclear medicine industry, competition in the nuclear medicine arena is no longer limited to products alone but encompasses a comprehensive comparison of isotope resources, manufacturing processes, and international clinical operation capabilities. While continuously enriching its pipeline of nuclear medicine products, GRAND PHARMA is also enhancing its self-developed platform, simultaneously filling gaps in overseas clinical applications, self-research platform construction, and large-scale production capabilities. This allows for the rapid introduction of mature and high-quality global assets for domestic transformation, while also supporting domestic innovative projects like GPN01530-2 to conduct overseas clinical trials directly with the FDA. Looking to the future, GRAND PHARMA is expected to leverage its global industrial system to export more innovative nuclear drugs originating from China and serving cancer patients worldwide, deeply engaging in the global transformation of the nuclear medicine industry.