The registration clinical study conducted in China of GPN00289, a global innovative temperature-sensitive embolic agent product of Grand Pharma, for transarterial chemoembolization of primary liver cancer has completed the first patient enrollment recently.
The study is a prospective, multi-center, randomized, parallel-controlled clinical study. It aims to evaluate the safety and effectiveness of GPN00289 for transarterial chemoembolization of primary liver cancer. The completion of the first patient enrolment in the registration clinical study of GPN00289 is another major R&D progress of the Group in the direction of tumor intervention in the field of nuclear medicine anti-tumor diagnosis and treatment.
GPN00289 is a temperature sensitive embolic material that granted innovative medical device qualification certification by the National Medical Products Administration of China (NMPA) for the treatment of hypervascular benign and malignant tumors. The product has the characteristics of temperature response and high plasticity. It can undergo liquid-solid phase transition with changes in temperature, and can embolize blood vessels of different sizes and shapes.
The product has good fluidity at the room temperature. After being transported to the blood vessels of the diseased tissue through the microcatheter, in-situ solidification from the peripheral blood vessels to the main supply blood vessels is formed at human body temperature, thereby achieve complete embolization of the peripheral blood vessels of the diseased tissue. It can effectively prevent the formation of collateral circulation, block arterial blood flow more completely, permanently and effectively, and is suitable for embolization treatment of various hypervascular parenchymal organ tumors, especially the embolization therapy for benign and malignant tumors of the hypervascular liver.
In addition to being used in combination with existing chemotherapy drugs, GPN00289 is also expected to be used in combination with the Group’s global innovative internal radiotherapy drug, YiGanTai Yttrium-90 Microsphere Injections. On the one hand, it can further enhance the therapeutic effect on liver cancer, and on the other hand, it is expected to expand the potential indications of YiGanTai Yttrium-90 Microsphere Injections. The product entered the registered clinical research stage in July 2024.
The nuclear medicine anti-tumor diagnosis and treatment platform is Grand Pharma’s high-end technology platform in the field of anti-tumor. Grand Pharma has achieved a comprehensive strategic plan in the fields of R&D, production, sales, regulatory qualifications and established a complete industrial chain. Grand Pharma, together with Sirtex Medical Pty Limited, cooperated with Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX) and ITM Isotope Technologies Munich SE to establish a world-class tumor intervention R&D platform and a radionuclide-drug conjugate R&D platform.
