SIR-Spheres® Y-90 Resin Microspheres Obtains Recommendation from NICE and Approval from the FDA to Conduct Clinical Trials on Primary Liver Cancer
(March 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 Group’s associate Sirtex Medical Pty Ltd core anti-tumor drug SIR-Spheres® Y-90 resin microspheres obtained recommendation from the National Institute for Health and Care Excellence (“NICE”) in the treatment of unresectable advanced hepatocellular carcinoma (“HCC”) in adults, and obtained an approval from the US Food and Drug Administration (“FDA”) to conduct clinical trials on primary liver cancer.
SIR-Spheres® Y-90 resin microspheres are used in selective internal radiation therapy for malignant liver tumors. The SIR-Spheres® Y-90 resin microspheres are delivered to the vasculature of liver tumor via a worldwide leading interventional technology, and then emit high doses of beta radiation to destroy tumor cells, which are the only radioactive microspheres around the world approved by the FDA.
NICE is an important organization of National Health Service (“NHS”) in England, and is one of the recognized premier health technology assessment organizations in the world. More than 75% of the governments and health technology assessment agencies in the world regard NICE’s recommendations as an important decision-making basis for bringing products into their own medical insurance reimbursement. As recommended by NICE, the use of selective internal radiation therapy (“SIRT”) using SIR-Spheres® Y-90 resin microspheres in England and Wales will be a fully funded and reimbursed option for adult patients with HCC, on the conditions that it is used for patients with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate. This approval opens the potential to treat thousands of patients who would apply to treat with SIR-Spheres® Y90 resin microspheres, annually, in the UK. Besides, SIR-Spheres® Y-90 resin microspheres obtaining recommendation from NICE is a milestone for its global medical insurance reimbursement access, which is expected to accelerate its access to medical insurance reimbursement in other emerging markets (such as Brazil), further expand its market shares, and help more liver cancer patients worldwide to receive the treatment of SIR-Spheres® Y-90 resin microspheres.
In addition, SIR-Spheres® Y-90 resin microspheres have been approved by the FDA to conduct clinical trials on primary liver cancer in order to apply for marketing license of primary liver cancer in the United States. The clinical trial is a single arm trial and patients will be recruited in the near future.
The results of clinical studies prove that SIR-Spheres® Y-90 resin microspheres can significantly increase tumor response rate, reduce tumor burden and achieve tumor downstaging, so that patients can gain the chances to undergo surgical resection. It can also significantly prolong the progression-free survival, control tumor progression and increase the waiting time for liver transplantation. In the meantime, SIR-Spheres® Y-90 resin microspheres bring less side effects and higher quality of life for patients. With its remarkable clinical efficacy, SIR-Spheres® Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. 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).
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: “Two important developments demonstrate the clinical efficacy and competitive advantages of SIR-Spheres® Y-90 resin microspheres, helping more liver cancer patients worldwide receive treatment. The NICE recommendation proves that the treatment of SIR-Spheres® Y-90 resin microspheres has positive effects on the quality of life and economic benefits of HCC patients.”
“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. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including United Stated based OncoSec, Australia based Sirtex and Telix Pharmaceuticals Limited (ASX: TLX), the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich 3product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and Immunotherapy 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 Group makes full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization processes for innovative products and provide cancer patients with more advanced and diverse treatment options in the world.”