GRAND PHARMA (00512) nuclear medicine partner Telix innovative product TLX101 for the treatment of newly diagnosed primary glioblastoma overseas phase I study made a key progress setting a new benchmark for global brain cancer treatment.

Recently, GRAND PHARMA (00512), a tech-innovative and international pharmaceutical company listed on the Hong Kong Stock Exchange, announced progress in the development of its nuclear medicine. The company's global innovative radiopharmaceutical drug (RDC) TLX101, which is used for the treatment of primary glioblastoma multiforme (brain cancer), has completed patient enrollment for its Phase I clinical trial (IPAX-2) conducted overseas. No dose-limiting toxicity (DLT) was observed, even at the maximum dose administered (two doses of 5GBq each, totaling 10GBq). Industry experts believe that TLX101 has the potential to overcome traditional treatment bottlenecks in glioblastoma and become a pioneering innovative treatment in the field. The successful completion of this overseas clinical milestone is a strong validation of the clinical value and development potential of TLX101. With the accelerated global development pace of GRAND PHARMA's innovative nuclear medicine products, the company is expected to further strengthen its leading position in the global blue ocean market of nuclear medicine. TLX101 achieves a new breakthrough in clinical trials, leading the way in innovative treatments for glioblastoma multiforme GRAND PHARMA's TLX101 is an RDC drug used for the treatment of glioblastoma multiforme, which can freely penetrate the blood-brain barrier and target the overexpressed L-type amino acid transporter 1 (LAT-1) in glioblastoma cells to induce apoptosis for therapeutic effects. This "targeted + radiotherapy" dual-action mode can precisely target solid tumors and eliminate tiny metastases that are difficult to reach with surgery and radiotherapy. Through the use of the companion diagnostic agent TLX101-CDx and PET imaging technology, precise patient stratification before treatment can be achieved. TLX101 has been granted orphan drug designation by the US FDA and is a highly promising innovative treatment for brain gliomas worldwide. The IPAX-2 study conducted in this release is an international multicenter, open-label Phase I dose-exploration clinical trial aimed at evaluating the safety and tolerability of TLX101 in combination with postoperative standard therapy (external radiotherapy and temozolomide) for the treatment of primary glioblastoma multiforme. The research covers four study centers in Australia, Austria, and the Netherlands and has enrolled 12 patients in three escalating dose cohorts. As of now, the study has reached the maximum dose administered, with no observed dose-limiting toxicity throughout, demonstrating excellent safety and tolerability data and providing a solid foundation for determining the maximum tolerated dose for subsequent key clinical trials. Patients will continue to receive standard therapy until the end of the study, after which the MTD will be confirmed as the primary endpoint. At the same time, a pivotal study of TLX101 for the treatment of recurrent glioblastoma multiforme (IPAX BrIGHT) is actively enrolling and dosing patients in Australia and the Netherlands, and has also been approved in Austria and Belgium and is about to enroll patients. This marks TLX101 as the first radiotherapeutic drug therapy to enter Phase III development for glioblastoma multiforme, leading the global clinical development process. Previously, the overseas Phase II clinical trial of TLX101 (IPAX-Linz study) has preliminarily validated the clinical benefits of TLX101. Clinical results have shown that the median overall survival (OS) for patients with recurrent glioblastoma multiforme treated with TLX101 is approximately 11.9 months (around 32.2 months since initial diagnosis), significantly better than traditional treatment regimens, with overall good safety and no serious adverse events, laying a solid foundation for the subsequent clinical development and application of the product. It is reported that central nervous system tumors are the tenth leading cause of death worldwide, with up to 90% being brain tumors. Glioblastoma multiforme originates from astrocytes, accounting for 50.1% of all malignant primary central nervous system tumors and is one of the most aggressive primary brain tumors, also known as the "king of cancer." This disease is classified as Grade 4 by the World Health Organization (WHO), indicating the highest degree of malignancy. The annual incidence of glioblastoma in China is approximately 6.4 per 100,000 people, with an incidence of 3-5 per 100,000 for glioblastoma multiforme, and a median age of diagnosis of 65 years. The high malignancy and high recurrence rates of this tumor, even with standard treatment combining surgery, radiotherapy, and chemotherapy, results in a median survival period of only 12-15 months for patients, with a 10% five-year survival rate, highlighting the significant unmet clinical needs for effective treatments. According to data from Bain Consulting, the global market size for glioblastoma treatments has reached 7.522 billion RMB in 2023, and it is expected to reach 13.968 billion RMB by 2029, with an average annual compound growth rate of approximately 8.8%. If the development of GRAND PHARMA's TLX101 progresses smoothly in the future, it may provide a new treatment option for glioblastoma multiforme and serve as a new growth driver for the company. With a comprehensive global strategy and continuous reinforcement of the entire industrial chain, GRAND PHARMA's nuclear medicine anti-tumor sector maintains high-quality and high-speed growth. The core product's sales volume and innovation pipeline advancement form a virtuous cycle, with innovative barrier products' revenue proportion continuing to increase, becoming the core growth engine for the company's long-term development. The overseas clinical breakthrough of TLX101 further deepens the company's treatment layout in the field of brain cancer and validates the company's "Go Global" global development strategy. GRAND PHARMA stated that in the future, the company will continue to adhere to an innovative concept centered around patients, increase research and development investment in the global nuclear medicine field, accelerate the clinical progress and translation of key innovative products, and continuously enrich and improve the product pipeline and overall industrial chain layout in a global operation. With a strategic layout of global operation and dual-loop development, the company will continue to consolidate its leading position in the global nuclear medicine anti-tumor field, contribute to overcoming more malignant tumors, improve the quality of life for global patients, and drive China's nuclear medicine industry towards the forefront of the world.