Hope City Brings New Breakthrough for Liver Cancer Patients in China with Y-90 Glass Microspheres

　　【Pharmaceutical Network Industry Dynamics】Boao Lecheng Pilot Zone in Hainan is regarded as the "City of Hope" by patients in China, thanks to its special zone policies and the benefits of the Free Trade Port policy. Through a series of innovative measures such as optimized approval processes,打通channels, and advance stockpiling, the zone accelerates the availability of international innovative drugs and medical devices, ensuring that "medicine waits for patients" instead of "patients waiting for medicine." Recently, there has been new progress in the Lecheng Pilot Zone, this time bringing good news for liver cancer patients!
 

May 6 news: Boston Scientific announced that the company's TheraSphere Yttrium-90 Glass Microspheres System (Y90 Glass Microspheres), as a clinically urgently needed imported medical device, has been approved by the Hainan Provincial Drug Administration for the treatment of liver malignancies at Boao Super Hospital within the Lecheng Pilot Zone.
 

Liver cancer is a tumor disease that poses a serious threat to human health. Globally, about 850,000 new cases of liver cancer are reported each year, and in China, new cases account for 45% annually. A large number of patients still face significant unmet needs.
 

It is reported that Y90 glass microspheres are the world's first radioactive glass microspheres and have also received FDA approval in the United States as a selective internal radiation therapy technology for unresectable primary liver cancer. They have been used internationally for over 20 years.
 

According to a press release from Boston Scientific, Y90 glass microspheres combine traditional radiotherapy with transvascular interventional therapy, offering liver cancer patients an innovative "Selective Internal Radiation Therapy" (SIRT).
 

The treatment principle is as follows: Through a single minimally invasive interventional surgery, millions of glass microspheres containing the radioactive substance Y90 are injected into the nourishing blood vessels of liver tumors and embedded within the tumor. The β-rays released by Y90 kill tumor cells at close range. With an average penetration distance of only 2.5mm, the β-rays minimize damage to normal liver tissue and adjacent organs, making the treatment more direct and precise.
 

In 2018, Grand Pharmaceutical Group, in collaboration with CDH Genetech, acquired Sirtex and introduced Yttrium-90 Microspheres Injection. In August 2020, the injection was approved for marketing in China based on clinical trial data obtained overseas, successfully resolving the long-standing issue of Yttrium-90 Microspheres Injection being available abroad but not in the Chinese market. In May 2022, Grand Pharmaceutical announced that its globally innovative product, SIR-Spheres Yttrium-90 Microspheres Injection for treating malignant liver tumors, had been officially applied in China. Additionally, Southeast University Affiliated Zhongda Hospital, Tianjin Medical University Cancer Institute and Hospital, Hunan Provincial People's Hospital, and the First Affiliated Hospital of Xi'an Jiaotong University have all successfully completed precise interventional clinical surgeries using Yttrium-90 Microspheres Injection.
 

In addition, the Y90 glass microsphere system clinical trial project, led by Zhongda Hospital Affiliated to Southeast University and jointly participated by 10 tertiary hospitals in China, has been officially implemented, with the first surgery completed in September 2021.
 

Notably, in March 2021, Boston Scientific signed a cooperation agreement with Chengdu Nuret Medical Technology Co., Ltd. regarding equity investment, technology transfer, and localized production. According to the agreement, Boston Scientific transferred its TheraSphere Y90 glass microsphere technology for internal radiation therapy of liver cancer to Nuret, in order to accelerate the localized production of this medical product in China.
 

As Boston Scientific's Y90 glass microspheres have been approved for urgent clinical import, they will bring good news to some Chinese liver cancer patients, allowing them to receive treatment with this medical technology. It is also hoped that this medical product will be officially approved in China as soon as possible, benefiting more liver cancer patients in China.