GRAND PHARMA (00512): The global innovative radiopharmaceutical product SIR-Spheres yttrium [90Y] microspheres injection has reached the clinical endpoint in the treatment of HCC clinical trials conducted in the United States.

GRAND PHARMA (00512) announced that its joint venture company Sirtex Medical Pty Ltd's SIR-Spheres yttrium [90Y] microspheres injection (Y-90 TheraSphere) has successfully reached the clinical endpoint in the United States for the treatment of inoperable hepatocellular carcinoma (HCC) in the DOORwaY90 study. Previously, the Food and Drug Administration (FDA) in the United States had formally approved the SIR-Spheres yttrium [90Y] microspheres injection for a new indication for the treatment of inoperable HCC based on the groundbreaking mid-term data from the DOORwaY90 clinical trial. The successful completion of the DOORwaY90 study not only signifies the completion of the clinical research but also provides solid clinical evidence for yttrium [90Y] radioembolization therapy as a definitive treatment option for inoperable HCC that is both effective and hepatoprotective. SIR-Spheres yttrium [90Y] microspheres injection is the first and only selective internal radiation therapy product approved by the FDA for dual indications of inoperable HCC and colorectal cancer liver metastases, and the related clinical data will provide strong support for expanding indications in China. This achievement demonstrates the group's excellent overseas clinical registration capabilities, laying a solid foundation for the subsequent overseas research and registration of self-developed innovative nuclear medicine products. SIR-Spheres yttrium [90Y] microspheres injection is a selective internal radiation therapy product for malignant liver tumors that uses leading global interventional technology to inject yttrium [90Y] resin microspheres into the tumor blood vessels in the liver, releasing high-energy beta radiation to kill tumor cells, providing the dual advantages of radioactive drugs and precise interventional therapy. The DOORwaY90 study conducted in the United States is a key, forward-looking, multicenter clinical study that uses segmented dose-response technology to perform yttrium-90 selective internal radiation therapy (SIRT) for inoperable HCC patients. The data from the study shows that the study has successfully achieved the pre-specified primary endpoints: a complete response rate (CR) as high as 90% as assessed by independent central review and an overall response rate (ORR) of 99%. All evaluable patients responded to treatment, with a local tumor control rate of 100%, making it one of the highest response rates reported for Y-90 therapy to date. In addition, the therapeutic effect of SIR-Spheres yttrium [90Y] microspheres injection is long-lasting, with 75% of patients experiencing a duration of response exceeding 6 months, a median duration of response of 295 days, and over 95% of patients maintaining stable liver function at 12 months. The excellent clinical results of this study fully reflect the personalized dosimetry plan of SIR-Spheres yttrium [90Y] microspheres injection, which achieves significant tumor response without damaging liver reserve function, surpassing traditional treatment options and further expanding the application space for targeted liver treatment of inoperable HCC. The product was approved by the FDA and the European Medicines Agency in 2002 and received marketing approval from the China Food and Drug Administration in 2022 for the treatment of patients with inoperable colorectal cancer liver metastases. For more than two decades, the product has been used by more than 150,000 patients in over 50 countries and regions worldwide, and its safety and efficacy have been widely recognized by the clinical community. It has been recommended by several international authoritative organizations including the Barcelona Clinical Liver Cancer Guidelines (BCLC), the National Comprehensive Cancer Network (NCCN), the European Society for Medical Oncology (ESMO) Guidelines for the Diagnosis, Treatment, and Follow-up of Liver Cancer (2025 edition), the European Association for the Study of the Liver (EASL) Guidelines for Liver Cancer (2025 edition), the National Institute for Health and Care Excellence (NICE) in the United Kingdom, and has been included in the Primary Liver Cancer Diagnosis and Treatment Guidelines (2026 edition), the Colorectal Cancer Liver Metastasis Diagnosis, and Comprehensive Treatment Guidelines (2025 edition), the Chinese Society of Clinical Oncology (CSCO) Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 edition), and the Chinese Liver Transplant Clinical Practice Guidelines (2021 edition). According to GLOBOCAN 2022 data, there are approximately 870,000 new cases of liver cancer globally, ranking it as the sixth most common cancer, with about 760,000 deaths, ranking it the third leading cause of cancer deaths. According to the 2024 National Cancer Center report in China, there were around 370,000 new cases of liver cancer in 2022 (accounting for 42.5% of global cases), ranking it as the fourth most common cancer, with approximately 320,000 deaths (accounting for 42.1% of global deaths), ranking it as the second leading cause of cancer deaths, with the highest proportion in the world. Primary liver cancer, particularly HCC, accounts for 85-90% of cases, with surgery being the preferred treatment for early HCC. However, due to the insidious nature of liver cancer, lack of early symptoms, and difficulties in early diagnosis, less than 30% of liver cancer patients are suitable for curative treatment at the initial diagnosis. The recurrence and metastasis rate of liver cancer after curative resection is as high as 50-70% within 5 years, with a 5-year survival rate of less than 20% in North America and even lower in China, at only 12%. Therefore, effective treatment methods are urgently needed for HCC patients. With the precision interventional treatment of Y-90 TheraSphere microsphere injections in China and the expansion of new indications, accessibility of the product for liver cancer patients in China will increase, bringing new treatment options for more Chinese patients with liver cancer. The group's oncology nucleotide diagnosis and treatment sector has achieved a comprehensive layout in research and development, production, distribution, and sales. With over 1,000 employees worldwide, research and development is centered in Boston, Massachusetts, and Chengdu, Sichuan Province, with production facilities in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries and regions globally. The group's oncology nucleotide diagnosis and treatment sector recorded revenue of approximately 950 million Hong Kong dollars in 22025, representing a year-on-year increase of approximately 61.0%. The core product Y-90 TheraSphere microsphere injection continued to rapidly expand its volume, with revenue growing approximately fifteenfold over the past four years. The group has established a world-class international platform for tumor intervention research and development and a RDC drug development platform. Following the treatment concept of integrated tumor diagnosis and treatment, the group has reserved 16 innovative products in the research and development registration stage, covering five radioactive isotopes including 68Ga, 177Lu, 131I, 90Y, and 89Zr, and spanning seven types of cancer including liver cancer, prostate cancer, brain cancer, among others. At the early stage of development, the focus is on RDC drugs, with over 10 products in the pipeline. In terms of product categories, covering both diagnostic and therapeutic nuclear medicines, the group provides a global leading anti-tumor solution with multiple indications for patient treatment and an integrative approach to diagnosis and treatment. The global research and development of innovative products within the sector have progressed smoothly. In China, Y-90 TheraSphere microsphere injections were successfully launched in January 2022 for the treatment of colorectal cancer liver metastases and received approval for a Phase II registration clinical trial for inoperable HCC in May 2025. The global innovative temperature-sensitive embolization agent GPN00289 completed patient enrollment for a registration clinical trial in October 2025. In terms of overseas registration, SIR-Spheres yttrium [90Y] microspheres injection was formally approved for a new indication earlier than scheduled in the United States in July 2025 for the treatment of inoperable HCC, making it the first and only selective internal radiation therapy product approved by the FDA for dual indications of inoperable HCC and colorectal cancer liver metastases. In August 2025, it received European CE certification for additional indications for liver cancer, further expanding its comprehensive coverage in the treatment of inoperable liver cancer and strategically expanding its market space. Additionally, the group is collaborating with domestic and international experts to develop other indications for yttrium [90Y] microsphere injections and will adopt an internationalized registration pathway to accelerate the global market expansion of the product. Currently, the group has six innovative RDC products approved for registration clinical trials within the oncology nucleotide diagnosis and treatment sector, one of which has entered the NDA stage, and three have entered Phase III clinical trials, including the products TLX591-CDx for diagnosing prostate cancer, TLX591 for treating prostate cancer, TLX250-CDx for diagnosing clear cell renal cell carcinoma, and ITM-11 for treating gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). In addition, the group's globally innovative targeted fibroblast activation protein (FAP) small molecule RDC drug GPN01530 received FDA approval for a Phase I/II clinical trial for diagnosing solid tumors, marking the group's first self-developed RDC product to receive FDA approval for clinical research. Its successful approval for clinical research sets an important precedent for the group's international development of its nuclear medicine product pipeline, showcasing the outstanding clinical pre-development and international registration capabilities of the group's nuclear medicine technology platform and representing a significant milestone in the global research and registration process of the group's oncology nucleotide diagnosis and treatment sector. Furthermore, the group's global innovative diagnostic radionuclide drug GPN02006 targeting fibroblast activation protein glycosylating three ("GPC-3") achieved a milestone breakthrough in a researcher-initiated Phase I clinical study (IIT clinical study) conducted in China and garnered an oral presentation at the 2025 North American Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. The product has great potential and is expected to become the world's first diagnostic RDC product for hepatocellular carcinoma (HCC) targeting the GPC-3 marker. The group's radiopharmaceutical research and production base, GRAND PHARMA, located in the Wengjiang District of Chengdu, Sichuan Province, China, completed acceptance in April 2025, received a Class A "Radiation Safety Permit" from the Ministry of Ecology and Environment in May, and officially commenced operations at the end of June. The base is the world's first closed-loop platform for nuclear medicine, covering the full cycle from isotope preparation, nuclear medicine research, clinical production, to commercialization, and has the capability to manage the entire lifecycle from early research to clinical transformation and market sales. The research efficiency is internationally leading; it addresses the bottleneck issue of nuclear medicine, breaking the import dependency deadlock with 14 high-standard GMP production lines that meet the requirements for a variety of scale-up production needs. It has established a comprehensive intelligent management system across the entire process, ensuring nuclear power-level safety and unmanned intelligent manufacturing to achieve zero radiation leakage, zero pollution discharge, and zero excess professional irradiation, meeting the highest global standards for nuclear facilities. It has established a world-class research and production quality and operational system, making it one of the most comprehensive and high-level intelligent factories in terms of nuclide variety and automation worldwide. The research and production base will further solidify the group's foundation in the nuclear medicine industry, accelerate the implementation of the global innovative research pipeline, promote high-quality development of the group in the nuclear medicine industry, cultivate high-value blockbuster products, and lay a solid foundation for the localization of the group's radiopharmaceuticals. In the future, the group will continue to strengthen research and development in the oncology nucleotide diagnosis and treatment sector, enrich and improve product pipelines and industry layout, form a cluster of nucleotide anticancer diagnosis and treatment products with Y-90 TheraSphere microsphere injections as the core, and continuously consolidate the group's leading position in the global field of nuclear medicine and cancer treatment. The group has always attached great importance to the research and development of innovative products and advanced technologies, putting patient needs at the core and driving technological innovation. Targeting unmet clinical needs, the group has increased investment in global innovative products and advanced technologies, enriched and improved product pipelines and industry layouts, adopted a "global operating layout, dual-cycle business development" strategy, forming a new pattern of development with mutual promotion between domestic and international cycles. Leveraging the group's industrial advantages and research and development capabilities, rapidly bringing innovative technological products to market, the group aims to provide more advanced and diverse treatment options for patients globally.