China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the official launch of its SIR-Spheres (Y-90 microsphere injection) in mainland China for the treatment of malignant liver tumors. The product received approval in February 2022 for patients with unresectable liver metastases from colorectal cancer who have failed standard therapy.
Product Mechanism and Innovation
SIR-Spheres is a targeted internal radionuclide therapy consisting of millions of radioactive resin microspheres (20-60 microns in diameter) delivered via catheter into the liver arteries supplying blood to tumors. These microspheres release high-energy beta radiation to kill tumor cells with precision. It remains the only product globally approved for selective internal radiation therapy (SIRT) of colorectal cancer liver metastases and was added to China’s “Guidelines for the diagnosis and treatment of primary liver cancer” in 2019.
Market Potential and Acquisition Background
Grand Pharma acquired the SIR-Spheres product through its USD 1.4 billion purchase of Australian firm Sirtex Medical Ltd in September 2018. First approved in the US in 2003, the medical device has been administered to 120,000 patients worldwide. The product entered China’s Hainan Boao Lecheng International Medical Tourism Pilot Zone via a special access scheme in September 2021.
Commercialization and Development Plans
Grand Pharma aims to make this treatment available to China’s large market, where there are 400,000 new liver cancer cases and about 380,000 new colorectal cancer cases annually, with 30%-50% of colorectal cancer patients developing liver metastasis. The company is also leveraging the SIR-Spheres platform to enhance its radiopharmaceutical capabilities, with 10 innovative products in development based on six nuclides, including Y-90.-Fineline Info & Tech
