Yttrium-90 resin microspheres have a disease control rate of over 90%, GRAND PHARMA (00512) has achieved the closure of the industrial chain to build a leading position in the field of nuclear medicine.

Following the innovative core drug TLX591-CDx and TLX591 for prostate cancer diagnosis and treatment, GRAND PHARMA (00512) has released another product-related positive news. Recently, the company's innovative core drug product Yisuantai Yttrium [90Y] Microsphere Injection has made multiple research achievements debut at the American Society of Clinical Oncology (ASCO) and the Asia-Pacific Primary Liver Cancer Experts Meeting (APPLE) in 2025, garnering international recognition for its drug potential and showcasing the huge clinical potential of GRAND PHARMA's core drug products. In addition, GRAND PHARMA has also launched innovative products in the ophthalmology field, such as GPN01768 (TP-03, Lotilana eye drops, 0.25%), a global innovative ophthalmic drug for the treatment of demodex blepharitis, which has recently been officially approved for marketing in Macau, China. This not only lays a foundation for the future approval of the product in the Greater Bay Area of Guangdong, Hong Kong, and Macau, but also has the potential to further promote its landing in mainland China. The positive news has driven the company's valuation reshaping, with several research institutions raising the company's stock price expectations. CICC has raised GRAND PHARMA's target price three times, with the latest target price being 9.6 Hong Kong dollars, while Huatai has given the company a target price of 10.15 Hong Kong dollars. As of the closing on May 23, the company's stock price reached a historical high of 9.19 Hong Kong dollars, up more than 50% compared to early May, and up more than 130% from the low point of the year. The research results presented at the global industry conference have achieved a disease control rate of 90% and have refreshed the landscape of liver cancer treatment. ASCO and APPLE conferences are both authoritative conferences in the industry. ASCO's annual meeting is the world's largest and most authoritative clinical oncology conference, bringing together many world-class oncology experts and serving as the first release platform for many important clinical research findings and clinical trial results in oncology. APPLE serves as an international leading academic platform for global hepatologists, oncologists, basic researchers, and clinicians to exchange and share research results and clinical advances in the field of liver cancer, making it one of the most influential liver cancer research conferences in the Asia-Pacific region. Yisuantai Yttrium [90Y] Microsphere Injection is a heavyweight core product in GRAND PHARMA's anticancer diagnosis and treatment sector. It is the world's only product for selective internal radiation therapy (SIRT) for liver metastases from colorectal cancer. The product was officially launched in China in May 2022 and has been used by over 150,000 people in more than 50 countries and regions globally. The continued selection of research results at two major global conferences signifies international recognition of the clinical value of the product. It has become a global focus in the treatment of hepatocellular carcinoma (HCC). Among the over 70 Chinese studies selected at this year's ASCO, two were solely dedicated to GRAND PHARMA's Yisuantai Yttrium [90Y] Microsphere Injection, one from the team of Academician Dong Jiahong at Tsinghua University's Affiliated Chang Gung Hospital and the other from the team of Professor Zhang Hui at the First Affiliated Hospital of the Military Medical University. In addition, there were 15 research results on Yttrium-90 resin microspheres included in the APPLE conference. This indicates that Yisuantai Yttrium [90Y] Microsphere Injection has become a leading mainstream treatment for HCC. The research not only provides a precise predictive model for the clinical efficacy of Yttrium-90 resin microspheres but also further confirms its significant advantages in tumor control, tumor regression, and increasing chances for surgery. This fully highlights the clinical advantages and global impact of the product, which will further boost China's academic influence in the field of liver cancer treatment. According to the actual research results, Yttrium-90 resin microspheres achieved an objective response rate of 87.8%, a disease control rate of 90.9%, and a regression rate of 76.9% for HCC patients, providing them with opportunities for curative surgery. As one of GRAND PHARMA's core products in the anticancer diagnosis and treatment sector, Yisuantai Yttrium [90Y] Microsphere Injection has already demonstrated its clinical potential to the market with impressive sales performance. By the end of 2024, the product had treated nearly 2,000 patients, achieving nearly 500 million Hong Kong dollars in sales revenue in 2024, with a year-on-year growth rate exceeding 140%. Sales revenue has increased by over 100% for two consecutive years. GRAND PHARMA continues to accelerate the clinical popularization of its products through operator supervision and training. The company has provided surgical theory or skills training to over 1,100 doctors from 70 hospitals, enabled over 170 doctors to register as surgical doctors, and trained 70 doctors through strict one-on-one training with international and domestic renowned experts to acquire qualifications for independent surgery. Another 85 doctors have obtained qualifications for assistant surgical operations, and 16 experts have become training tutors. With the accelerated deployment and increase in the volume of Yisuantai Yttrium [90Y] Microsphere Injection, the company's overall revenue is expected to reach new heights in the future. Building an integrated product ecosystem for diagnosis and treatment to solidify its global innovative product pipeline layout, GRAND PHARMA is currently one of only four companies in the world to have successfully commercialized nuclear medicine. The company continues to enrich and improve its product pipeline and industry layout, forming a cluster of core products in anticancer diagnosis and treatment with Yisuantai Yttrium [90Y] Microsphere Injection at its core, solidifying its leadership position in the global anticancer diagnosis and treatment sector. In terms of HCC diagnosis and treatment, the company's integrated product layout is beginning to take shape. In addition to the successfully marketed Yisuantai Yttrium [90Y] Microsphere Injection, the company has also made breakthrough progress in GPN02006, a precise diagnostic nuclear medicine for HCC. GPN02006 is a global innovative diagnostic radiopharmaceutical targeting glypican-3 (GPC-3) based on radionuclide-antibody conjugation technology, showing high specificity and affinity for the GPC-3 target. From the clinical research data, GPN02006 combines excellent safety and imaging functionality, and is expected to become the world's first radiolabeled drug targeting the GPC-3 target for HCC diagnosis (RDC). Currently, the investigator-initiated clinical research (IIT clinical research) of this product conducted in China has achieved a milestone breakthrough, and won an oral presentation at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in North America.In addition, the recent development of two other innovative nuclear medicines by the company has further realized the company's innovative layout in the field of nuclear medicine. According to the recent announcement by the company, the innovative investigational RDC drug TLX591-CDx for diagnosing prostate cancer has completed the enrollment and dosing of all patients in the domestic Phase III clinical trial, and plans to submit a domestic market application within this year; the global innovative RDC drug TLX591 for treating prostate cancer has also recently received acceptance for an international multicenter Phase III clinical trial application from the National Medical Products Administration. These two products will achieve a complete "diagnosis and treatment integration" for prostate cancer patients, potentially bringing more precise and efficient diagnosis and treatment solutions for prostate disease patients domestically. During the research and development registration phase, GRAND PHARMA has reserved a total of 15 innovative products covering five radioactive isotopes including 68Ga, 177Lu, 131I, 90Y, and 89Zr, spanning seven types of cancers including liver cancer, prostate cancer, kidney cancer, and brain cancer. The product range includes both diagnostic and therapeutic options, providing patients with multiple treatment choices for various indications and a globally leading integrated approach to cancer treatment. The world's first "zero-radiation" intelligent nuclear medicine factory: High-standard nuclear medicine base achieves industrial chain closure In addition to the continuous market expansion of innovative products, GRAND PHARMA's recent production and research layout in the nuclear medicine industry has once again leveraged its growth potential in the nuclear medicine field. Recently, the company's global research and production base for nuclear medicine in Wenjiang, Chengdu has been awarded a Class A "Radiation Safety Permit" by the National Ministry of Ecology and Environment, and is set to officially commence operation in June 2025. It is reported that this base is the world's first nuclear medicine full industry chain closed-loop platform, with a total planned investment of over 3 billion RMB, focusing on core areas such as isotope process development and preparation, nuclear medicine coupling technology, automated labeling technology, covering nuclear medicine research, process development, quality research, non-clinical research, intelligent production, as well as precise distribution through a one-stop full lifecycle management, establishing a world-class research and production quality and operational system. The base has 14 production lines that meet the requirements of Good Manufacturing Practice (GMP) for drug production, and has built a full chain AI operation system and an intelligent manufacturing system, capable of autonomously producing a variety of isotopes and nuclear medicine formulations, with a reserved production line for alpha nuclide drugs, making it one of the most complete in terms of isotope varieties and automation levels among global intelligent factories, fully meeting the diverse and scalable preparation needs of the company's therapeutic and diagnostic nuclear medicines. Furthermore, the base boasts ten highlights and technological breakthroughs: (1) equipped with a cyclotron from Belgium's IBA, possessing autonomous production capabilities for key isotopes, solving the dilemma of China's reliance on imported isotopes; (2) the full-process automation of isotopes, stabilizing production capacity to an international leading level; (3) a smart manufacturing system has been established, constructing an automated synthesizer for precise control over the "molecular factory," significantly enhancing experimental and production stability; (4) establishing a fully automated packaging system, achieving "zero contact" throughout the entire process; (5) an automated ligand production line enabling parallel development of multiple categories of nuclear medicines, reducing production costs; (6) constructing a fully linked chain system, increasing production efficiency by 300%; (7) achieving full chain AI intelligent operation, greatly improving operational efficiency; (8) equipped with the highest international standard radioactivity operation hot cell, completely blocking the leakage path of radioactive materials; (9) building the world's first comprehensive radiation monitoring system for the radioactive drug field, achieving "zero discharge" and "zero exceedance"; (10) the "ligand + nuclide + technology platform + intelligent production" "four in one" breaking international monopolies. These highlights and technological breakthroughs not only meet the standards of the International Atomic Energy Agency (IAEA), but also set a new safety benchmark for the nuclear medicine industry. The GRAND PHARMA global research and production base for nuclear medicine in Wenjiang, Chengdu is the world's first "zero-radiation" intelligent nuclear medicine factory, as well as one of the world's most complete in terms of isotope varieties and automation levels among intelligent factories. It marks the successful establishment of a global closed-loop platform covering the "research-production-sales" full industry chain, realizing a strategic leap from laboratory research to industrial mass production, filling the gap in international standards for industrialization of radioactive drugs with "China Intelligent Manufacturing," and promoting the global upgrade of the nuclear medicine industry. At the same time, this base will work with the company's R&D center in Boston, the GRAND PHARMA-Shandong University Institute of Radiopharmacy, and others to collectively build a global network of nuclear medicine R&D centers, providing the global market with radioactive drug solutions with completely independent intellectual property rights. GRAND PHARMA stated that in the future, the company will continue to strengthen the research and development and construction of the nuclear medicine anti-tumor diagnosis and treatment sector, enrich and improve the product pipeline and industry layout, forming a core nuclear medicine anti-tumor diagnosis and treatment product cluster centered on Easyganthai Yttrium [90Y] Microspheres Injection, continuously solidifying the company's position as a leading enterprise in the global nuclear medicine anti-tumor diagnosis and treatment field.