Yuanda Pharmaceutical Yttrium [90Y] microsphere injection approved for listing is expected to become a new "weapon" for liver cancer treatment

On the evening of February 9, Hong Kong stock company Yuanda Pharmaceutical announced that its core product of company Sitex Medical Pty Ltd, SIR-Spheres Yttrium [90Y] microsphere injection, has recently obtained a drug registration certificate issued by the State Food and Drug Administration (NMPA) and can be used for the treatment of patients with non-resectable colorectal cancer liver metastases who have failed standard treatment.

So far, the most important product of Yuanda Pharma's radiopharmaceutical diagnosis and treatment platform, yttrium [90Y] microsphere injection, has successfully landed in the Chinese market, becoming the first therapeutic radiopharmaceutical approved for listing by NMPA in 2022, and the first product in mainland China to be approved for the treatment of liver metastases of colorectal cancer.

In retrospect, yttrium [90Y] microsphere injection was approved for marketing by the US FDA and the EU EMA in 2002, and is still the only product in the world for selective internal radiation therapy (SIRT) for liver metastasis of colorectal cancer.

Studies have shown that about 30% to 50% of colorectal cancer patients develop liver metastases, 80% to 90% of liver metastases cannot be initially resected radically, and patients with unresectable liver metastases have a 5-year survival rate of less than 10%.

Yttrium [90Y] microsphere injection has been listed overseas for more than 20 years, has accumulated more than 120,000 clinical applications, safety and efficacy have been widely recognized clinically, and entered the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2022 Edition)" and other authoritative guidelines at home and abroad, with high clinical recognition.

The successful introduction of yttrium [90Y] microsphere injection provides a new and effective treatment method for patients with liver malignancy in China, and provides potential surgical opportunities, making up for the gap in the local treatment of liver metastasis of colorectal cancer, and also marking a new international precision interventional treatment program in the field of liver malignancy in China.

In fact, as early as 2018, Yuanda Pharmaceutical co-opted with CDH Genetech to acquire Sitex, introduced SIR-Spheres yttrium [90Y] microsphere injection, determined the strategic direction of differentiated R&D layout in the field of oncology, and was approved to apply for listing based on clinical trial data obtained overseas in August 2020.

It is worth mentioning that Yuanda Pharmaceutical has also established a radiopharmaceutical diagnosis and treatment platform with SIR-Spheres yttrium [90Y] microsphere injection as the core and the global layout as the development idea. At present, the broad pharmaceutical radiological diagnosis and treatment platform has 10 products, covering multiple cancer species, providing patients with multi-cancer, multi-means and integrated diagnosis and treatment of the world's leading anti-tumor solutions.

Broad Pharmaceutical said that in the future, it will work with the important associated company Sitex, the shareholding company Telix and the recently cooperated ITM company to increase investment and development of global innovative products in the field of radionuclide diagnosis and treatment drugs for unmet clinical needs, enrich and improve product pipelines and industrial layouts, and strive to build a leading radionuclide drug diagnosis and treatment platform with a dual system development path of local + global research and development and production. (In painting)