GP (HK)’s Blockbuster Product SIR-Spheres® Y-90 Resin Microspheres Completes the First Patient Administration, Making Steady R&D Progress in the Field of Tumor Treatment
(May 9, 2021 - Hong Kong) China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the core product SIR-Spheres® Y-90 resin microspheres of Sirtex Medical Pty Ltd (“Sirtex”), an associate company of the Group, has been successfully completed the first patient administration recently, following the approval by the US Food and Drug Administration (“FDA”) to conduct a clinical trial for hepatocellular carcinoma (“HCC”).
Sticking to patients-centered and innovation-driven, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. The Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and anti-tumor platform integrating diagnostics and treatment. The Group adopts the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other.
The SIR-Spheres® Y-90 resin microspheres clinical study, DOORwaY90, is being conducted in the United States to evaluate the safety and efficacy of SIR-Spheres® Y-90 resin microspheres as a first-line treatment for patients with unresectable or inoperable HCC patients in order to obtain approval for the HCC indication in the United States. The study will be conducted at 15 oncology centers, led by MD Anderson Cancer Center, and will enroll 100 patients in an open-arm study. The primary clinical endpoints will be the overall response rate (ORR) and duration of response (DoR). DOORwaY90 will be the first U.S. registration trial to utilize and delineate personalized dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment, further providing high-quality supporting data for the use of SIR-Spheres® Y-90 resin microspheres in HCC patients to benefit more HCC patients.
SIR-Spheres® Y-90 resin microspheres is a targeted internal radionuclide product for liver malignant tumors, applying the world’s leading interventional technology is used to inject SIR-Spheres® Y-90 resin microspheres into the blood vessels of liver tumors and release high-energy beta radiation to kill tumor cells. In 2002, this product was approved by the U.S. FDA for the treatment of unresectable colorectal cancer liver metastases (mCRC) based on the pivotal research CRI9101 (n=74), and in the same year it was approved by the European Union for the treatment of unresectable advanced liver malignancies.
SIR-Spheres® Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. With its remarkable clinical efficacy, it is recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO). It is also covered by medical insurance in places such as the United States and Europe. In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition) , delineating clear clinical demands.
The registration of SIR-Spheres® Y-90 resin microspheres in China is progressing smoothly. In August 2020, the National Medical Products Administration of the PRC was approved to file the new drug application for the treatment of colorectal liver metastases based on clinical trial data obtained overseas. The new drug application was accepted in November, 2020.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The successful completion of the first patient administration of SIR-Spheres® Y-90 resin microspheres is an important progress made by the Group in the field of tumor treatment, laying the foundation for benefiting more liver cancer patients worldwide in the future. Looking ahead, the Group will make full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide cancer patients with more advanced and diverse treatment options in the world.”