Sirtex Medical and Grand Pharmaceutical Group Limited granted NDA approval of SIR-Spheres Y-90 resin microspheres in China 

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Sirtex Medical has announced with Grand Pharmaceutical Group Limited, that SIR-Spheres Y-90 resin microspheres have been approved by the national medical products administration (NMPA) for the treatment of patients with colorectal cancer liver metastases.

According to a recent press release, the NDA approval of SIR-Spheres for the Chinese market is the first therapeutic radiopharmaceutical approved by the NMPA in 2022 and is the only radioactive microsphere product approved by the NMPA based on clinical trial data obtained outside of China. The first procedure of selective internal radiation therapy (SIRT) using SIR-Spheres in China was successfully performed in September 2021, which at that time utilised the pilot implementation policy for commercialised medical devices in Hainan.

According to GLOBOCAN 2020, there were 410,000 new cases of liver cancer with 390,000 deaths in China. Additionally, in 2020, there were over 550,000 new cases of colorectal cancer with more than 280,000 deaths in China. Those morbidity and mortality rates are about twice as high as average global rates.

“The prognosis for patients suffering from liver cancer in China is poor, with the five-year survival rate being roughly 12%,” notes Dr. Tang Weikun, Chairman of the Board at Grand Pharmaceutical Group Limited. “The use of SIR-Spheres to downstage liver tumors to the point where they can be surgically removed has been well documented in other countries. Our hope is that by expanding the reach of SIR-Spheres to China, we will have a similar impact, with improved treatment outcomes and survival rates among patients diagnosed with liver tumors.”


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