Grand Pharmaceutical’s Nuclear Medicine Meets Primary Endpoint in US Clinical Trial for Unresectable HCC

On April 13th, Grand Pharmaceutical issued an announcement stating that the US DOORwaY90 clinical trial of its nuclear medicine product SIR-Spheres® Yttrium [90Y] Microspheres Injection (Yigantai®) for unresectable hepatocellular carcinoma (HCC) has successfully reached the preset clinical endpoint, according to China Pharmaceutical News. This achievement provides crucial clinical data support for the liver-directed treatment of unresectable hepatocellular carcinoma.

Yttrium [90Y] Microspheres Injection is a selective internal radiation therapy product for malignant liver tumors. It delivers yttrium [90Y] resin microspheres to liver tumor blood vessels through interventional technology, releasing high-energy beta radiation to kill tumor cells, integrating the dual characteristics of radioactive drugs and precise interventional therapy, as reported by Medical Device Technology.

With more than 20 years on the market, the product has been applied in over 50 countries and regions worldwide, with a cumulative usage of more than 150,000 person-times. It has been recommended by international authoritative guidelines such as the National Comprehensive Cancer Network (NCCN) and included in domestic clinical practice guidelines such as the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026 Edition)".

The DOORwaY90 study is the first prospective, multi-center pivotal clinical trial in the United States to conduct 90Y selective internal radiation therapy for unresectable HCC using fractional dosimetry technology. Previously, the US Food and Drug Administration (FDA) had approved Yttrium [90Y] Microspheres Injection for the indication of unresectable HCC based on the breakthrough interim data of this study, making it the world’s first and only selective internal radiation therapy product approved by the FDA to cover both unresectable HCC and colorectal cancer liver metastasis indications.

The achievement of the clinical endpoint this time provides complete clinical evidence for Yttrium [90Y] radioembolization as an efficient and liver-protective treatment plan for unresectable HCC, and also offers data support for the expansion of the product’s indications in China, according to China National Medical Products Administration (NMPA) official website.

Data from the World Health Organization (WHO) shows that in 2022, there were approximately 870,000 new cases of liver cancer and 760,000 deaths worldwide; China had 370,000 new liver cancer cases and 320,000 deaths, accounting for more than 40% of the global total. Hepatocellular carcinoma accounts for 85% to 90% of all liver cancer cases. Due to insidious early symptoms, less than 30% of patients can receive curative surgery when diagnosed, with a 5-year recurrence and metastasis rate of 50% to 70% after surgery, and the 5-year survival rate of Chinese liver cancer patients is only 12%, leaving significant unmet clinical needs.

In the field of nuclear medicine, Grand Pharmaceutical has built a global R&D, production and sales system, with Boston and Chengdu as the R&D cores, and production bases in Boston, Frankfurt, Singapore and Chengdu, covering more than 50 countries and regions with its sales network. Zhang Wei, Director of Grand Pharmaceutical’s Global Nuclear Medicine R&D Center, stated that the company focuses on "integrated diagnosis and treatment", with 16 innovative nuclear medicine products in the R&D and registration stage, covering 5 key radionuclides and 7 major cancer types.

Six innovative RDC drugs have entered registered clinical studies, 1 has entered the NDA stage, and 3 have entered Phase III clinical trials. In June 2025, Grand Pharmaceutical’s Chengdu Wenjiang Radioactive Drug R&D and Production Base was put into operation, building a closed-loop platform for the entire nuclear medicine industry chain and realizing independent control of isotope preparation, R&D, production and other links.

The achievement of the preset endpoint in this US clinical study is an important reflection of Grand Pharmaceutical’s international R&D and registration capabilities, and lays a foundation for the global commercialization and indication expansion of Yttrium [90Y] Microspheres Injection. The product is expected to benefit more global hepatocellular carcinoma patients, and Grand Pharmaceutical will continue to promote the innovative R&D of nuclear medicine to strengthen its layout in the global nuclear medicine anti-tumor field.