Yuanda Pharmaceutical (00512): Innovative global radioactive product Sir-spheres® yttrium [90Y] microsphere injection approved for new indications in Europe

Zhitong Finance App News, Yuanda Pharmaceutical (00512) announced that Sir-spheres® yttrium [90Y] microsphere injection (Yigantai®) of Sirtex Medical Pty Ltd, an associated company of the Group, has recently been granted CE certification for new indications in Europe for the treatment of patients with liver cancer. The new indications approved this time have expanded the scope of application of the treatment to multiple indications such as unresectable hepatocellular carcinoma (HCC) and unresectable colorectal cancer liver metastasis (mCRC), to include multiple indications such as unresectable intrahepatic cholangiocarcinoma (ICC), liver metastasis due to neuroendocrine tumors (MNeT), or other liver metastases, covering a more comprehensive classification of primary liver cancer and secondary liver metastases. In addition, the US Food and Drug Administration (FDA) recently approved new HCC indications for sir-spheres® yttrium [90Y] microsphere injections. The registration milestones achieved by yttrium [90Y] microsphere injections in the two major markets of Europe and the US have further promoted the comprehensive coverage of this product in the treatment of unresectable liver cancer, achieved a strategic expansion of market space, and also demonstrated the Group's excellent overseas clinical registration capabilities and commercial operation capabilities, providing an important guarantee for the subsequent global development of self-developed and innovative nuclear drug products. On the other hand, overseas relevant clinical data will also provide key support for the product to expand liver cancer-related indications in China. At the same time, the Group is actively cooperating with Chinese and foreign experts to develop other indications for yttrium [90Y] microsphere injections, and will use the “China and US Double News” international registration path to promote the global market expansion of this product. Relying on the global layout of nuclear drugs and an autonomous and controllable industrial ecosystem, the Group has built a nuclear medicine innovation matrix covering integrated diagnosis and treatment and domestic and international dual cycles, forming a closed-loop system for the entire “R&D, production and sales” industry chain, continuing to lead the global expansion of nuclear drug anti-tumor diagnosis and treatment products and consolidating its position as an industry leader.

Sir-spheres® yttrium [90Y] microsphere injection was approved for marketing by the FDA and Europe in 2002, obtained marketing approval from the China Drug Administration in 2022 to treat patients with colorectal cancer liver metastases that cannot be surgically resected, and was approved by the China Drug Administration in May 2025 to carry out phase II registered clinical trials to treat unresectable HCC. E-Gantai® Yttrium [90Y] microsphere injection has been rapidly released since it was approved for marketing in China. By the end of 2024, it had treated nearly 2,000 patients, and achieved sales revenue of nearly HK$500 million in 2024, with a year-on-year growth rate of over 140%. In July 2025, SIR-spheres® yttrium [90Y] microsphere injection was officially approved by the FDA in advance for additional indications based on groundbreaking mid-term data from the DoorWay90 clinical trial. It is used for non-resectable HCC, and there is no limit on tumor diameter. According to mid-term clinical results, the objective remission rate of ir-spheres® yttrium [90Y] microsphere injection for unresectable HCC was as high as 98.5%; all evaluable patients showed treatment response, indicating a 100% local tumor control rate; furthermore, the median duration of remission was over 300 days. The FDA's approval of the new indications marks Sir-spheres® yttrium [90Y] microsphere injection as the world's first and only FDA-approved selective internal radiation therapy product for unresectable HCC and liver metastases in colorectal cancer. Combined with the European approval of the new indications, these registration milestones mark additional international recognition of SIR-spheres® in the treatment of liver cancer.

Over the 20 years since its launch, the product has been used more than 150,000 times in more than 50 countries and regions around the world, and its safety and efficacy have been widely recognized. It has obtained the Barcelona Clinical Liver Cancer Guidelines (BCLC), the US National Comprehensive Cancer Network (NCCN), the European Society of Internal Oncology Guidelines (ESMO), the European Association for the Study of the Liver (EASL), the British National Health Care Professional Organization ( The National Institute for Health and Care Excellence (NICE) has recommended treatment guidelines from various international authorities, and has entered the “2024 CSCO Primary Liver Cancer Diagnosis and Treatment Guidelines”, “Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)”, “China Colorectal Cancer Liver Metastasis Diagnosis and Comprehensive Treatment Guidelines (2023 Edition)”, and “Clinical Practice Guidelines for Liver Cancer Liver Transplantation in China (2021 edition)”.

According to GLOBOCAN's 2022 data, liver cancer has about 870,000 new cases worldwide, ranking sixth among tumors; the number of deaths is around 760,000, ranking third. According to the 2024 National Cancer Report of the National Cancer Center of China, in 2022, there were about 370,000 new cases of liver cancer in China (42.5% of the world), ranking fourth among tumors; the number of deaths was about 320,000 (accounting for 42.1% of the world), ranking second; they all ranked first in the world. Primary liver cancer mainly includes three different pathological types: HCC, ICC, and mixed hepatocellular carcinoma-cholangiocarcinoma. Among them, HCC is the most common, accounting for about 85%, and ICC accounting for more than 10%. Surgical resection is the preferred method for treating early-stage liver cancer, but since the incidence of liver cancer is hidden, early symptoms are not obvious or typical, and early diagnosis is difficult, less than 30% of liver cancer patients are suitable for curative treatment at the time of initial diagnosis, and treatment is difficult, so the prognosis is poor, and the ratio of incidence rate to death rate is as high as 1: (0.8-0.9); even through radical resection, tumor recurrence and metastasis rate 5 years after liver cancer resection is as high as 50% to 70%; the 5-year survival rate in North American countries and regions is less than 20%, and even lower, only in China, so it is extremely necessary for 12% of liver cancer patients Effective treatment means. With the expansion of new indications and clinical popularization of SIR-spheres® yttrium [90Y] microsphere injection for precise interventional treatment methods around the world, it will significantly improve the accessibility of this product and bring new treatment options to liver cancer patients around the world.

The Group has achieved a comprehensive layout of R&D, production, distribution, and sales in the nuclear drug anti-tumor diagnosis and treatment sector. The division has more than 900 employees worldwide, based on R&D bases centered in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, and sales networks covering more than 50 countries and regions around the world. The Group has achieved a global nuclear drug industry chain layout.

The Group cooperated with Sirtex Medical Pty Ltd and collaborated with Telix Pharmaceutical Limited and ITM Isotope Technologies Munich SE to build a world-class oncology intervention research and development platform and radionuclide conjugate drug (RDC) development platform. Focusing on the integrated treatment concept of cancer diagnosis and treatment, we currently have 15 innovative products in the R&D registration stage, covering 5 types of radionuclides, including 68 Ga, 177 Lu, 131I, 90Y, and 89Zr, covering 7 types of cancer including liver cancer, prostate cancer, kidney cancer, brain cancer, etc.; in the early development stage, RDC drugs are the main focus, and the product reserve has reached 12 models. In terms of product types, it covers the diagnosis and treatment of two types of nuclide drugs, providing patients with a world-leading anti-tumor solution with multiple treatment options, multiple methods, and integrated diagnosis and treatment. Currently, the Group has five innovative RDCs approved for registered clinical research in the nuclear drug anti-tumor diagnosis and treatment sector. Four of them have entered phase III clinical phase, including TLx591-cdx, a product for diagnosing prostate cancer, TLX591, a product for diagnosing clear cell renal cell carcinoma, TLx250-cdx, and ITM-11, a product for treating gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). Furthermore, the globally innovative diagnostic radiopharmaceutical GPN02006, which targets phosphatidylinositol proteoglycan 3 (GPC-3) based on radionuclide-antibody conjugation technology, achieved a landmark breakthrough in clinical research (IIT clinical study) initiated by researchers in China and received an oral report at the 2025 North American Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting; clinical study data showed that GPN02006 showed excellent safety and imaging efficacy: none of the subjects reported any drug-related effects after administration Adverse reactions, excellent safety and tolerability; high-quality imaging can be achieved 30 minutes after administration, which fully meets the needs of rapid clinical diagnosis of hepatocellular carcinoma. The GPN02006 product has great potential and is expected to become the world's first hepatocellular carcinoma (HCC) diagnostic RDC product targeting GPC-3. Up to now, the Group is the company with the largest total reserves of innovative diagnostic and therapeutic RDC drugs in phase III clinical research in China, and is also one of the innovative pharmaceutical companies with the richest product pipeline and integrated diagnosis and treatment layout in the field of nuclear drugs against cancer in the world.

The Group's Yuanda Pharmaceutical radiopharmaceutical R&D and production base in Wenjiang District, Chengdu City, Sichuan Province, China was completed and inspected in April 2025, obtained a Class A “Radiation Safety License” issued by the Ministry of Ecology and Environment in May, and officially put into operation at the end of June. The base is the world's first closed-loop platform for the entire nuclear drug industry chain, covering the entire “isotope preparation - nuclear drug development - clinical production - commercialization” chain, forming a full life cycle management capability from early R&D to clinical transformation to marketing and sales, leading international R&D efficiency; solving the “stuck neck” problem of nuclear drugs, 100% independent production to solve the import dependency problem, and 14 high-standard GMP production lines to achieve multi-variety and large-scale preparation requirements; establish a full-process intelligent management system, nuclear power level safety and unmanned intelligent manufacturing, which can achieve “zero leakage” and “zero external emissions” of radiation “, Occupational irradiation” “Zero Exceeding Standards”, meeting the world's top nuclear facility standards; establishing a world-class R&D, production quality and operation system, it is currently one of the smart factories with the most complete range of nuclides and the highest degree of automation in the world. The R&D and production base will further consolidate the foundation of the Group's nuclear drug industry, accelerate the implementation of the global innovative R&D pipeline, promote the Group's high-quality development of the nuclear drug industry, cultivate high-value major varieties, and lay a solid foundation for the localization of the Group's radiopharmaceuticals. In the future, the Group will continue to strengthen the R&D and construction of the nuclear drug anti-tumor diagnosis and treatment sector, enrich and improve the product pipeline and industrial layout, form a nuclear drug anti-tumor diagnosis and treatment product cluster centered on E-Gantai® yttrium [90Y] microsphere injection, and continue to consolidate the Group's position as a leading enterprise in the field of nuclear drug anti-tumor diagnosis and treatment in the world.

The Group has always attached great importance to research and development of innovative products and advanced technology, with patient needs as the core, scientific and technological innovation, increasing investment in innovative global products and advanced technology, enriching and improving product pipelines and industrial layout in response to unmet clinical needs, adopting a “global operation layout, dual cycle business development” strategy to form a new pattern of domestic and international dual cycle linkage development and mutual promotion, giving full play to the Group's industrial advantages and R&D strength, and quickly launch innovative scientific and technological products to provide patients around the world with more advanced and diverse treatment plans.