Go Global strategy breaks through again! GRAND PHARMA (00512) independently developed innovative FAP targeting core drug approved for clinical use in the United States, opening up a market space of over a trillion yuan.

Recently, there has been a significant breakthrough in the innovative field of China Meheco Group GRAND PHARMA (00512), an independently developed global innovative radiopharmaceutical agent (RDC) GPN01530, has officially received FDA approval to conduct Phase I/II clinical studies for the diagnosis of solid tumors in the United States. This not only signifies the international recognition of GRAND PHARMA's layout in the star target fibroblast activation protein (FAP), but also reflects the company's comprehensive strength in international clinical development and registration applications, which will be an important milestone for the company to further promote the global layout of other innovative drugs in the future. If GPN01530's development progresses smoothly in the future, the product is expected to become a significant breakthrough in overcoming the challenges in the diagnosis and treatment of solid tumors, reshaping the landscape of solid tumor diagnosis and treatment with remarkable product advantages, seizing a leading market position globally, and bringing new hope to patients worldwide. Targeting a billion-dollar level target, benefiting tens of millions of patients worldwide GRAND PHARMA's GPN01530 is not just another innovative nuclear drug in the conventional sense. Its uniqueness lies in the broad application prospects of the target behind the product, the technological bottlenecks it overcomes, and the vision of "diagnosis and treatment integration" it embodies. This makes the product a core competitive edge for enterprises in the nuclear drug field, with the potential to become a benchmark example of Chinese innovative nuclear drugs going global. The announcement shows that GPN01530 has optimized the structure of FAP ligands, increasing their uptake in tumor tissue while reducing their uptake in normal tissue. Preclinical research results show that compared to other FAP ligands, GPN01530 demonstrates rapid tumor targeting, higher tumor uptake, and better pharmacokinetic properties. Additionally, preliminary studies on humans in phases I and II have shown that GPN01530 is well tolerated, provides rapid background clearance, strong and lasting lesion uptake, and, compared to 18F-FDG, displays better clinical image contrast and accurate detection of positive lesions, significantly improving diagnostic efficiency compared to other RDC drugs targeting FAP-like targets. This superior performance compared to similar and alternative products signifies that GPN01530 has the potential to be Best-in-Class, not only replacing 18F-FDG in the market but also potentially setting new standards for FAP-targeted drugs in the current market. Fibroblast activation protein (FAP) is one of the important markers of tumor-associated fibroblasts (CAFs), playing a vital role in processes such as extracellular matrix remodeling, tumor cell proliferation regulation, and tumor immune suppression, promoting tumor invasion and metastasis, making it a novel, specific target for tumor diagnosis and treatment. Studies have shown that FAP is not expressed or has low expression in normal tissues but is highly expressed in 90% of epithelial tumor tissues and CAFs in various tumor microenvironments. This makes FAP a highly potent target for a wide range of cancers and can be widely used in various cancer types such as lung cancer, gastric cancer, colorectal cancer, and others. Besides its broad application in solid tumors, the high sensitivity of the FAP target adds more certainty to its commercial potential. Compared to the commonly used PET/CT imaging agent Fluorine [18F]-Fluorodeoxyglucose (18F-FDG), the imaging agent of the FAP target has higher sensitivity. Research shows that FAPI PET/CT exhibits better performance in detecting digestive tract tumors compared to 18F-FDG PET/CT, with a sensitivity that remains around 90%, much higher than the 40% to 68% sensitivity of 18F-FDG, and its results are not affected by blood sugar levels, eliminating the need for patients to fast and wait for a long time, thus significantly improving patient compliance. Due to the widespread applicability of the FAP target and its high sensitivity, the target has been regarded by the international academic community as the most promising "billion-dollar-level" cutting-edge target in the nuclear medicine field after PSMA and SSTR, attracting heavy investments from international nuclear drug leaders such as Novartis. According to data from the World Health Organization, the number of cancer cases worldwide is expected to increase from 19.3 million in 2020 to 24.6 million by 2030. The market size for drugs is also continuously expanding, with Frost & Sullivan predicting that the pharmaceutical market in the United States alone is expected to reach nearly $141.5 billion by 2025, exceeding $200 billion by 2030, and the global market size is expected to surpass $480 billion during the same period. If GPN01530 successfully launches in the future and is widely used in clinical practice, it is estimated that it will benefit more than tens of millions of patients worldwide, with immeasurable positive implications for enhancing the global diagnosis and treatment of solid tumors. More importantly, as the core diagnostic product of GRAND PHARMA's FAP platform, GPN01530 is also expected to interact with therapeutic nuclear drug products, truly unlocking the enormous clinical value of "diagnosis and treatment integration," providing a new and comprehensive solution for cancer patients, from precise detection to targeted treatment. Strengthening the global competitiveness of the nuclear drug industry chain, and providing a new sample for overseas independent clinical trials The successful approval of GPN01530 for clinical trials in the United States reflects GRAND PHARMA's strategic choices and capabilities as a leading nuclear drug enterprise in China, as well as the rising trend of the Chinese nuclear drug industry in the global value chain. In fact, GRAND PHARMA has already established a global layout for the nuclear drug industry chain, spanning research and development, production, distribution, sales, and other processes. The company has established research and development centers in Boston and Chengdu as core bases, production facilities in Boston, Frankfurt, Singapore, and Chengdu, and has set up a sales network covering more than 50 countries and regions worldwide. From a product perspective, GRAND PHARMA is one of the most innovative drug enterprises globally in the field of nuclear drugs for anticancer treatment, with the richest product pipeline and integrated diagnosis and treatment layout. It is also the enterprise with the most reserves of Phase III clinical studies of diagnostic and therapeutic RDC innovative drugs in China. The company currently has 16 innovative products in the research and registration stage, covering 5 medical radioactive isotopes and 7 major cancer types, with 5 innovative RDC products approved for registration clinical trials and 4 entering critical Phase III clinical stages. In addition, the company has more than 10 early-stage research and development products, mainly RDC drugs. In terms of product categories, it covers both diagnostic and therapeutic nuclear drugs, providing patients with multiple treatment options for different indications, with a globally leading integrated diagnosis and treatment strategy for cancer. In recent years, GRAND PHARMA's nuclear drug products have been shining globally, continuously refreshing overseas clinical progress. Yttrium [90Y] microspheres, as a successful mature nuclear drug on the market, have been successively approved for new indications in the United States and Europe, expanding market space strategically. The ITM-11 for the treatment of gastrointestinal neuroendocrine tumors (GEP-NETs) in the United States has also been accepted by the FDA for NDA submission. Additionally, the liver cancer diagnostic drug GPN02006 garnered oral presentations at the 2025 SNMMI Annual Meeting, potentially becoming the world's first GPC-3-targeted hepatocellular carcinoma diagnostic RDC. On the industrial chain side, GRAND PHARMA's layout is also becoming increasingly comprehensive. This year, the GRAND PHARMA global research and production base for radiopharmaceuticals in Chengdu's Wenjiang district officially began operations at the end of June. It is currently one of the most comprehensive and highly automated intelligent factories globally in terms of the variety of isotopes, with 14 high-standard GMP production lines that can fully meet the needs for the large-scale preparation of therapeutic and diagnostic nuclear drugs within the group. Based on this, the company has built the world's first closed-loop platform for nuclear drug industrial chain, establishing a closed-loop system covering the research, production, and sales of nuclear drugs, breaking through key links in the global layout of nuclear drugs, truly realizing the complete independent control of the innovative nuclear drug product development, production, and sales industrial chain, bridging the gap from laboratory research to industrial mass production. Notably, based on this manufacturing base for radiolabeling and animal molecular imaging platforms, GRAND PHARMA has independently completed early research on the GPN01530 project, marking its first independently developed product to enter the FDA clinical stage since the Chengdu nuclear drug base began operations in June this year. This demonstrates the remarkable clinical pre-development and international registration capabilities of the technical platform. In addition, using GPN01530 as an example, GRAND PHARMA has also presented a new model for the internationalization of Chinese innovative drugs by deeply participating in overseas clinical trials and promoting the synchronous progress of clinical research both at home and abroad. This outward-bound model, distinct from simple product exports or equity licensing, involves a more in-depth and synergistic approach, enhancing the company's overseas clinical registration and industry layout capabilities through control of overseas clinical trials, and grafting the clinical trial experience of more mature markets back to China to further drive the listing process of products both domestically and internationally. The company stated that it will continue to promote the global research and registration work of GPN01530 based on the international registration pathway of "dual-filing" between China and the United States. Leveraging this as a foundation, the company will further deepen the global development strategy of this sector, actively promote the international clinical research and registration application of more independently developed innovative nuclear drug products, and potentially bring the wisdom of Chinese innovative nuclear drugs to more cancer patients worldwide, actively implementing the "Go Global" development strategy, leading the rise of the Chinese nuclear drug industry in the global value chain, and contributing Chinese solutions and strength to the global anti-cancer treatment industry.