Grand Pharma’s Global Innovative Radiopharmaceutical Drugs SIR-Spheres® Y-90 Microsphere Injection Were Approved for Commercialization by NMPA in China, For The Treatment of Colorectal Cancer Liver Metastases

Grand Pharma’s Global Innovative Radiopharmaceutical Drugs SIR-Spheres® Y-90 Microsphere Injection Were Approved for Commercialization by NMPA in China, For The Treatment of Colorectal Cancer Liver Metastases

(February 9, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that SIR-Spheres® Y-90 microsphere injection, the product of Sirtex Medical Pty Ltd (“Sirtex”), an associate company of the Group, has recently obtained the Drug Registration Certificate issued by the National Medical Products Administration of the People’s Republic of China (“NMPA”). The first indication of the drug approved in China is for the treatment of patients with unresectable liver metastases from colorectal cancer who have failed standard treatment.

According to the latest cancer database data of the International Agency for Research on Cancer (IARC), there was more than 550,000 new cases and more than 280,000 deaths of colorectal cancer in China in 2020. The “Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Liver Metastasis (2020 edition)” show that, liver metastasis is an important cause of death of colorectal cancer patients in China. About 30-50% of colorectal cancer patients will develop liver metastasis, and 80-90% of the 5-year survival rate of patients with unresectable liver metastases is less than 10%. SIR-Spheres® Y-90 microsphere injection is the first product approved in China for the treatment of liver metastases of colorectal cancer.

In 2002, SIR-Spheres® Y-90 microsphere injection was approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and it is still the only product in the world for selective internal radiation therapy (SIRT) for colorectal cancer liver metastases. During the 20 years since it was launched, SIR-Spheres® Y-90 microsphere injection has treated more than 120,000 patients worldwide, and its safety and efficacy have been widely clinically recognized. It is recommended by the guidelines issued by different institutions such as European Society for Medical Oncology (ESMO), National Comprehensive Cancer Network (NCCN), National Institute for Health and Care Excellence (NICE) for the treatment of colorectal liver metastases. For patients with unresectable liver metastases from colorectal cancer who failed standard treatment, the results of post-marketing clinical studies showed that the liver metastases were effectively controlled after treatment with SIR-Spheres® Y-90 microsphere injection, and the technical resection rate of inoperable patients is improved, allowing the patient to regain the opportunity for surgery.

In 2018, the Group and CDH Genetech Limited jointly acquired Sirtex and introduced SIR-Spheres® Y-90 microsphere injection. SIR-Spheres® Y-90 microsphere injection was approved in China to apply for commercialization in August 2020 based on clinical trial data obtained overseas. In November of the same year, NMPA officially accepted New Drug Application (NDA) of SIR-Spheres® Y-90 microsphere injection for colorectal cancer liver metastases. In September 2021, with the assistance of the Group, Sirtex successfully completed China’s first privileged licensed SIR-Spheres® Y-90 microsphere injection for the indication of primary liver cancer relying on the “Early and Pilot Implementation” policy for the overseas commercialized medical devices of Hainan Free Trade Port Boao Hope City International Medical Tourism Pilot Zone.

The Board of Grand Pharmaceutical Group Limited, commented, “The approval of SIR-Spheres® Y-90 microsphere injection for commercialization in China is expected to provide a brand new and effective treatment method for Chinese patients with liver malignant tumors, and provides potential surgical opportunities, which fills the gap of local treatment for colorectal cancer liver metastases, marking the field of liver malignant tumors in China ushered in a new international precision interventional treatment plan.

The Group always put a high value on the R&D of innovative products and advanced technologies in the field of radiopharmaceuticals, join hands with the important associate company Sirtex Medical Pty Ltd, the shareholding company Telix and the ITM company that has recently cooperated to increase the investment and development of global innovative products in the field of radionuclide diagnosis and treatment drugs for unmet clinical needs, enrich and improve product pipeline and industrial layout, and continuously enhance the Group’s global R&D strength in this field, provide assistance for the development of the industry, and strive to build an internationally leading radionuclide drug diagnosis and treatment platform with a dual-system development path of local + global R&D and production, strive to build an international leading radiopharmaceutical diagnosis and treatment platform.”