By Fineline Cube 
Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR‑Spheres Y‑90 resin microsphere injection (brand name: YiGanTai), a product of its associate company Sirtex Medical Pty Ltd., has received CE Mark approval in Europe for a broader range of liver‑cancer indications.
New Indications Covered
- Unresectable intrahepatic cholangiocarcinoma (ICC)
- Hepatic metastases from neuroendocrine tumors (mNET)
- Other liver metastases (e.g., from pancreatic, breast, or sarcoma origins)
The expansion lifts the therapy’s scope from its original focus on unresectable hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC) liver lesions to a comprehensive set of primary and secondary liver malignancies.
Global Regulatory Momentum
- European CE Mark – Adds a new therapeutic window for liver‑cancer patients in the EU.
- FDA Approval – The United States Food and Drug Administration recently authorized SIR‑Spheres for a novel HCC indication, reinforcing its standing in the U.S. market.
- NMPA Approval – The drug was first commercialized in China in 2022 for unresectable colorectal‑cancer liver metastases.
Clinical Impact
- DOORwaY90 Trial Interim Results – Demonstrated an objective response rate of 98.5% in unresectable HCC, with 100% local tumor control across all evaluable patients.
- Durable Response – Median duration of response exceeded 300 days, underscoring the treatment’s long‑lasting efficacy.
These data reinforce SIR‑Spheres’ position as a leading option for patients with inoperable liver tumors worldwide.-Fineline Info & Tech