"Go Global" once again bears fruit! GRAND PHARMA (00512) Yttrium [90Y] microspheres injection has reached the endpoint data of clinical trials in the United States, leading globally, driving a surge in independent global sales.

GRAND PHARMA (00512) Milestone Progress for Heavyweight Nucleic Acid Drug SIR-Spheres Yttrium [90Y] Microsphere Injection (Yi Gangtai)! On April 13, GRAND PHARMA announced that the clinical study of Yttrium [90Y] Microsphere Injection for the treatment of inoperable hepatocellular carcinoma (HCC) in the United States (DOORwaY90 study) has successfully reached its predetermined clinical endpoints, achieving very promising clinical data. The excellent clinical data not only signifies that the personalized dosimetric treatment mode of SIR-Spheres surpasses traditional treatment regimens, but also further expands the application space for targeted liver treatment of inoperable HCC patients, fully demonstrating the powerful efficacy and market potential of the product, and is expected to further promote the continuous high-speed sales of GRAND PHARMA's Yttrium [90Y] Microsphere Injection in global markets. It is worth mentioning that the U.S. FDA has previously approved Yttrium [90Y] Microsphere Injection for the indication of inoperable hepatocellular carcinoma based on the groundbreaking interim data from the DOORwaY90 clinical trial, making it the world's first and only selective internal radiation therapy product approved by the FDA for dual indications of inoperable HCC and colorectal cancer liver metastasis. The successful achievement of the clinical endpoints in the DOORwaY90 study not only provides solid clinical evidence for Yttrium [90Y] radioembolization therapy as a definitive treatment option for high-efficiency and liver-protective inoperable HCC, but the related clinical data will also provide strong support for its indication expansion in China. At the same time, this achievement also showcases GRAND PHARMA's excellent overseas clinical registration capabilities, laying an important foundation for the subsequent overseas development and registration of self-developed innovative nucleic acid drug products. The excellent clinical research data suggest that Yttrium [90Y] Microsphere Injection can achieve tumor response without damaging liver reserve function, and may completely change the landscape of HCC diagnosis and treatment, providing patients with longer survival and higher quality of life. In addition, the personalized dosimetric treatment mode of Yttrium [90Y] Microsphere Injection not only surpasses traditional treatment regimens but also further expands the application space for targeted liver treatment of inoperable HCC patients, offering patients more precise treatment options. The successful achievement of the predetermined endpoints in this clinical study will provide strong support for the further expansion of the indications of Yttrium [90Y] Microsphere Injection and directly promote the strategic expansion of the product's market space. Liver cancer is the sixth most common new cancer and the third leading cause of cancer death worldwide. According to GLOBOCAN 2022 data, there are approximately 870,000 new cases of liver cancer globally, with about 760,000 deaths. The 2024 National Cancer Report from the China National Cancer Center shows that in 2022, there were around 370,000 new cases of liver cancer in China (42.5% of the global total), ranking fourth among tumors; the number of deaths was about 320,000 (42.1% of the global total), ranking second; both proportions are the highest globally. Among all types of liver cancer, hepatocellular carcinoma (HCC) is the most common, accounting for 85%-90%. However, early symptoms of liver cancer are insidious and difficult to detect in a timely manner, resulting in less than 30% of patients being able to undergo curative surgery at the time of initial diagnosis. Even after undergoing surgery, the five-year recurrence and metastasis rate remains as high as 50%-70%. In terms of survival outcomes, the five-year survival rate for Chinese liver cancer patients is only 12%, indicating significant unmet treatment needs. Data suggests that by 2030, the global liver cancer treatment drug market is expected to reach around US$9.81 billion, and the HCC drug market in China is expected to reach around 48.7 billion RMB by 2030, indicating a very substantial market opportunity. The outstanding performance of Yttrium [90Y] Microsphere Injection in clinical trials provides an effective, accessible, and better-tolerated treatment option for mid- to late-stage liver cancer patients. With the successful clinical trial in the United States, its global commercial breakthrough will be further supported by strong data, not only benefiting domestic patients more quickly and widely in the future, but also assisting in improving the overall diagnosis and treatment level of liver cancer in China, and providing a better treatment choice for global patients, further promoting the high-speed growth of GRAND PHARMA's nucleic acid drug sector. Leading the global full-chain layout, continuously strengthening the barriers to the entire nucleic acid drug industry chain The successful completion of the Yttrium [90Y] Microsphere Injection clinical trial in the United States is a milestone progress for GRAND PHARMA's "Go Global" strategy, further showcasing the company's strong international research and development capabilities, and also reflecting the enormous potential of the company's nucleic acid drug platform. In the future, GRAND PHARMA is expected to continue to strengthen its global competitive advantage in the nucleic acid drug field, accelerate the research and development and commercialization of more innovative nucleic acid drugs, contribute to overcoming more malignant tumors and improving the quality of life for patients, and continue to consolidate its leading position in the global nucleic acid drug race. Over the years, GRAND PHARMA's core products and heavy pipeline in the nucleic acid drug sector have successively achieved milestone breakthroughs. The company's independently developed global innovative small molecule RDC drug targeting fibroblast activation protein (FAP), GPN01530, has been approved by the FDA to conduct Phase I/II clinical trials, becoming the company's first self-developed RDC product approved for clinical trials by the FDA. Its clinical approval also provides an important paradigm for the international development of the company's nucleic acid drug product pipeline, and demonstrates the excellent pre-clinical development and international registration capabilities of GRAND PHARMA's nucleic acid drug technology platform; the researcher-initiated clinical study of GPN02006 in China has made a milestone breakthrough, and received an oral presentation at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in North America, potentially becoming the world's first RDC product targeting GPC-3 for hepatocellular carcinoma diagnosis, continuously showcasing its global innovation strength. In terms of industrial infrastructure construction, the company's nucleic acid drug industry has achieved comprehensive independent and controllable capabilities. In June 2025, GRAND PHARMA's Chengdu Wenjiang Radiopharmaceutical Research and Production Base was officially put into operation, becoming the world's first closed-loop platform for the entire nucleic acid drug industry. The base has 14 high-standard GMP production lines, achieving independent and controllable full-chain production of isotopes, research and development, production, clinical and commercialization, overcoming critical bottlenecks in the nucleic acid drug process. The base is one of the most comprehensive in terms of radioisotope variety and automation level, providing solid support for the rapid industrialization of the company's global innovation achievements. The excellent performance of Yttrium [90Y] Microsphere Injection in clinical trials provides a high-efficiency, accessible, and better-tolerated treatment option for mid- to late-stage liver cancer patients. With the successful completion of its clinical trial in the United States, the product's global commercial breakthrough will be further supported by strong data, not only benefiting domestic patients more quickly and widely in the future but also assisting in improving the overall diagnosis and treatment level of liver cancer in China and providing a better treatment choice for global patients, further promoting the high-speed growth of GRAND PHARMA's nucleic acid drug sector.