お知らせ • Mar 21
Grand Pharmaceutical Group Limited Completes First Patient Enrolment and Dosing for International Multi-Center Phase III Clinical Trial in China of the Innovative RDC Product ITM-11
The Board of Grand Pharmaceutical Group Limited announced that an international multi-center Phase III clinical trial ("COMPOSE Trial") with ITM-11, an innovative radionuclide-drug conjugate ("RDC") product introduced by the Group, has completed the first patient enrolment and dosing in China recently. Previously, the Group entered into a product strategic cooperation agreement with ITM Isotope Technologies Munich SE ("ITM SE") in December 2021, through which the Group obtained the exclusive development, production and commercialization rights of three innovative RDC products developed by ITM SE, including ITM-11 and ITM-14D (TOCscan®), in Greater China (Mainland China, Hong Kong Special Administrative Region of China, Macau Special Administrative Region of China, and Taiwan Region of China). The completion of the first patient enrolment and dosing in China in the COMPOSE trial is another significant R&D progress for the Group in the field of nuclear medicine anti-tumor diagnosis and treatment. COMPOSE trial is a prospective, randomized, controlled, open-label, and international multi- center Phase III clinical trial. It plans to enrol approximately 250 patients in 11 countries around the world, including China, the United States, the United Kingdom, France, Germany, and Australia, to evaluate the efficacy and safety of ITM-11 compared with best standard of care therapy in patients with aggressive Grade 2 and Grade 3 well-differentiated, somatostatin receptor-positive ("SSTR+") gasteroenteropancreatic neuroendocrine tumors ("GEP-NETs"). The trial is currently in progress. In addition, the Group received approval in December 2024 from the National Medical Products Administration of the People's Republic of China ("NMPA") to conduct another Phase III clinical trial (the "COMPETE Bridging Trial") with ITM-11 in China, which aims to evaluate the efficacy and safety of ITM-11 Peptide Receptor Radionuclide Therapy (PRRT) in patients with inoperable, progressive, Grade 1 or Grade 2 well-differentiated, SSTR+ GEP- NETs compared to standard therapy. In terms of overseas research, the COMPETE Phase III clinical trial conducted by ITM SE successfully reached the primary clinical endpoint in January 2025, which will also provide positive data support for COMPETE bridging trial in China. These two Phase III clinical trials will help the ITM-11 product to fully cover all stages of the GEP-NETs. The Group obtained approval from the NMPA in March 2024 to participate in an international multi-center Phase III clinical trial (COMPOSE trial), which aims to evaluate the efficacy, safety, and patient-reported outcomes of ITM-11 PRRT compared with best standard therapy in patients with aggressive Grade 2 and Grade 3 well-differentiated, SSTR+ GEP-NETs. This clinical trial is in progress. The COMPETE bridging trial is designed to expand the potential applicable population of ITM-11 products to patients in China, and achieve full coverage of ITM-11 at all stages of the disease course of GEP-NETs. ITM-11 is a therapeutic RDC product based on radionuclide conjugated technology that targets GEP-NETs. It conjugates non-carrier-added 177Lu with a somatostatin analog, and attacks tumor cells by binding to the somatostatin receptor (SSTR) which is highly expressed on the surface of GEP-NET tumors. The non-carrier-added 177Lu in ITM-11 has several advantages over carrier added 177Lu: higher specific activity and purity, and fewer impurities with long half-lives, thus simplifying the handling of radioactive waste. ITM-11 received orphan drug designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). According to data from Frost & Sullivan, there were 71,300 newly diagnosed cases of GEP- NETs in China in 2020, with the incidence rate increasing yearly. The "Guidelines of Chinese Society of Clinical Oncology (CSCO) for Neuroendocrine Neoplasms (2021)" indicated that peptide receptor radionuclide therapy based on 177Lu is superior to the high-dose octreotide (somatostatin analogue) currently used as first-line treatment in terms of progression-free survival time (PFS) and objective response rate (ORR). ITM-11 together with ITM-14D, another RDC product introduced by the Group for the diagnosis of GEP-NETs, could form a product group to realize the integration of the diagnosis and treatment of GEP-NETs, which the group expects to provide a new diagnosis and treatment option for patients with GEP-NETs in China. By adhering to the treatment concept of integrated oncology diagnosis and treatment, the Group's nuclear medicine anti-tumor diagnosis and treatment segment has reserved 12 innovative products, including 5 radionuclides including 68Ga, 177Lu, 131I, 90Y and 89Zr, and covering 7 cancers including liver cancer, prostate cancer and brain cancer. In terms of product types, it covers two types of radionuclide drugs for diagnosis and therapy, providing patients with multi-indication treatment options, multi-methods and integrated diagnosis and treatment of the anti-tumor solutions. Currently, the Group has 4 innovative RDC drugs that have been approved to conduct clinical research in the nuclear medicine anti-tumor diagnosis and treatment segment, 3 of which have entered the Phase III clinical stage, including TLX591-CDx, for the diagnosis of prostate cancer, TLX250-CDx, for the diagnosis of clear cell renal cell carcinoma, and ITM-11, for the treatment of GEP-NETs. As for now, the Group has the largest total reserve of innovative diagnostic and therapeutic RDC drugs that have entered Phase III clinical studies in China, and also one of the innovative pharmaceutical companies in the world with the richest product pipeline and integrated diagnosis and treatment strategic plan in the field of nuclear medicine anti-tumor. The nuclear medicine anti-tumor diagnosis and treatment platform is the Group's high-end technology platform in the field of anti-tumor. The Group has achieved a comprehensive strategic plan in the fields of R&D, production, sales, regulatory qualifications and established a complete industrial chain. The Group, together with Sirtex Medical Pty Limited, cooperated with Telix Pharmaceuticals Limited and ITM SE to establish a world-class tumor intervention R&D platform and a radionuclide-drug conjugate R&D platform. It has nearly 800 employees, and is one of the most globalized segments of the Group. At the same time, the Group and Shandong University jointly established Grand Pharma - Shandong University Radiopharmaceutical Research Institute (-), and with the institute as the core, an early R&D platform for nuclear drugs has been established to carry out the independent R&D of RDC drugs. Currently, it has 12 products in the pipeline at the early R&D stage.
