Announcement • Apr 16
Grand Pharmaceutical Group Limited Announces Clinical Study Results and Product Pipeline Updates
Grand Pharmaceutical Group Limited announced that the clinical trial (“DOORwaY90”) conducted in the United States for the treatment of unresectable hepatocellular carcinoma (“HCC”) of SIR-Spheres® Y-90 resin microsphere injection of Sirtex Medical Pty Ltd, an associate company of the Group, has successfully met its clinical endpoint recently. Previously, the United States Food and Drug Administration (“FDA”) had officially approved SIR-Spheres® Y-90 microsphere injection for a new indication of unresectable HCC based on breakthrough interim data from the DOORwaY90 clinical trial. The successful completion of the DOORwaY90 study, which reached its clinical endpoint, not only marks the successful conclusion of this clinical research, but also provides solid clinical evidence for Y-90 radioembolization therapy as a definitive treatment option for unresectable HCC that is both highly effective and hepatoprotective. SIR-Spheres® Y-90 microsphere injection is the world’s first and only FDA-approved selective internal radiotherapy product for the dual indications of unresectable HCC and colorectal cancer liver metastases. The relevant clinical data will also provide strong support for the expansion of indications in China; at the same time, this achievement demonstrates the Group’s excellent overseas clinical registration capabilities and lays an important foundation for the overseas R&D and registration of subsequent self-developed innovative radiopharmaceutical products. SIR-Spheres® Y-90 resin microsphere injection is a selective internal radiotherapy product for liver malignant tumors. It uses interventional technology to inject Y-90 resin microspheres into liver tumor blood vessels, releasing high-energy ß radiation to kill tumor cells. It has the dual advantages of radioactive drugs and precise interventional treatment. The DOORwaY90 study conducted in the United States was the first pivotal, prospective, multicenter clinical study of Y-90 selective internal radiation therapy (SIRT) using partition dosimetry in patients with unresectable HCC in the United States. The study data shows that this research has successfully met its prespecified co-primary endpoints: demonstrating a 90% complete response (CR) rate and a best overall response rate (ORR) of 99%, as assessed by blinded independent central review; all evaluable patients responded to treatment, resulting in 100% local tumor control. In addition, the responses of SIR-Spheres® Y-90 microsphere injection were durable, with 75% lasting beyond 6 months and a median duration of 295 days, and over 95% of patients maintained stable liver function at 12 months. These clinical results fully demonstrate that the personalized dosimetry of SIR-Spheres® Y-90 microsphere injection can achieve significant tumor response without damaging liver reserve function. The product was approved for commercialization by the FDA and the European Medicines Agency in 2002, and was approved for commercialization by the National Medical Products Administration of the People’s Republic of China (NMPA) in 2022 for the treatment of patients with unresectable colorectal cancer liver metastases. Over the past 20 years since its commercialization, the product has been used by more than 150,000 people in more than 50 countries and regions around the world, and its safety and effectiveness have been widely recognized in clinical practice. It is also recommended in the treatment guidelines issued by different international authoritative organizations such as Barcelona Clinic Liver Cancer Guidelines (BCLC), National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO) Clinical Practice Guideline for diagnosis, treatment and follow-up of Hepatocellular carcinoma (2025), European Association for the Study of the Liver (EASL) Clinical Practice Guidelines for Hepatocellular Carcinoma (2025), National Institute for Health and Care Excellence (NICE), and has been included in several authoritative clinical practice guidelines in China, including Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2026 edition), Guideline for diagnosis and comprehensive treatment of colorectal liver metastases (2025 edition), Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition) of Chinese Society of Clinical Oncology (CSCO), Chinese clinical practice guidelines on liver transplantation for hepatocellular carcinoma (2021 edition). According to the data from GLOBOCAN 2022, there are approximately 870,000 new cases of liver cancer worldwide, ranking sixth among tumors; and approximately 760,000 deaths, ranking third. The 2024 National Cancer Report of the National Cancer Center of China shows that in 2022, there were approximately 370,000 new cases of liver cancer in China (accounting for 42.5% of the world), ranking fourth among tumors; there were approximately 320,000 deaths (accounting for 42.1% of the world), ranking second; and the proportions ranked first in the world. HCC is the most common primary liver cancer, accounting for 85%-90%. Surgical resection is the preferred method for treating early HCC, but because liver cancer is insidious, early symptoms are not obvious or typical, its early diagnosis is difficult, less than 30% of liver cancer patients are suitable for radical treatment at the initial diagnosis, and treatment is difficult, so the prognosis is poor, and the ratio of morbidity to mortality is as high as 1: (0.8- 0.9); even with radical resection, the 5-year tumor recurrence and metastasis rate after liver cancer resection is as high as 50% to 70%. In the nuclear medicine anti-tumor diagnosis and treatment segment, the Group has achieved a comprehensive layout in the fields of R&D, production, distribution, and sales, with over 1,000 employees worldwide. The Group has established a global nuclear medicine industry chain layout based on its R&D centers in Boston and Chengdu, production facilities in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries and regions worldwide. In 2025, the Group’s nuclear medicine anti-tumor diagnosis and treatment segment recorded revenue of approximately HKD 950 million, representing an increase of approximately 61.0% on an annual basis. Core product SIR-Spheres® Y-90 microsphere injection has continued to grow rapidly. This segment has achieved revenue growth of approximately fifteen times over four years. The Group has established a tumor intervention technology platform and a RDC technology platform. The Group adheres to the treatment concept of integrated oncology diagnosis and treatment. Currently, the Group has 16 innovative products in the pipeline at the R&D registration stage, covering 5 radionuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr as well as 7 cancers including liver cancer, prostate cancer and brain cancer.
