February 9, 2022—Sirtex Medical announced with its shareholder, Grand Pharmaceutical Group Limited, that the company’s SIR-Spheres Y-90 resin microspheres have been approved by China’s National Medical Products Administration (NMPA) for the treatment of patients with colorectal cancer liver metastases.

The NMPA approval for the radioactive microsphere product is based on clinical trial data obtained outside of China, noted the company.

According to Sirtex, the first procedure of selective internal radiation therapy using SIR-Spheres in China was successfully performed for a patient in September 2021, which at that time utilized the pilot implementation policy for commercialized medical devices in Hainan province.

The company noted that GLOBOCAN 2020 estimated that morbidity and mortality rates for liver and colorectal cancer in China are approximately twice as high as average global rates. In China in 2020, there were 410,000 new cases of liver cancer with 390,000 deaths and more than 550,000 new cases of colorectal cancer with more than 280,000 deaths.

Tang Weikun, PhD, who is Chairman of the Board at Grand Pharmaceutical Group Limited, commented in the press release, “The prognosis for patients suffering from liver cancer in China is poor, with the 5-year survival rate being roughly 12%. 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.”