The leading pharmaceutical company, GRAND PHARMA (00512), has achieved further research and development progress in global innovative RDC, which may provide a new treatment option for brain glioma.

Recently, good news came from the Hong Kong stock technology innovation pharmaceutical company GRAND PHARMA (00512). The company's important strategic partner in the field of radiopharmaceuticals, Telix Pharmaceuticals Limited (ASX: TLX), announced the preliminary results of the overseas Phase II clinical trial (IPAX-Linz study) of the global innovative RDC product TLX101 for the treatment of glioblastoma (brain cancer), confirming the benefits to patients. This is an important development in GRAND PHARMA's global layout in the field of nuclear medicine for anti-tumor diagnosis and treatment. TLX101 product has considerable potential and has received FDA orphan drug designation. It is reported that TLX101 can freely pass through the blood-brain barrier to reach the brain and target the overexpressed L-type amino acid transporter 1 (LAT-1) in glioblastoma cells to induce apoptosis for therapeutic effect. The product has received FDA orphan drug designation. Currently, TLX101's global R&D progress is smooth, with its Phase I clinical trial in China approved in April 2023, and overseas, the product is expected to submit a new drug clinical trial (IND) to the FDA in the first half of 2025 and start clinical trials in the second half of 2025. The IPAX-Linz study is an investigator-initiated Phase II clinical study aimed at evaluating the safety, tolerability, and preliminary efficacy of TLX101 in combination with external beam radiation therapy (EBRT) in patients with first or second recurrent high-grade gliomas (HGG), including glioblastomas. Clinical results show that TLX101 treatment is well tolerated, with no serious adverse events reported. The median overall survival (OS) of patients receiving TLX101 treatment was approximately 12.4 months (approximately 32.2 months from initial diagnosis). In comparison, the median survival of recurrent glioblastoma patients treated with EBRT alone was only 9.9 months. Josef Pichler, professor at Kepler University Hospital in Austria and chief investigator of the IPAX-Linz study, said, "TLX101 continues to demonstrate its enormous potential to improve the prognosis of high-grade glioma patients." According to the "Report on the Development of Malignant Tumors in China (2022)," the annual incidence rate of glioblastoma in China is about 6.4/100,000, making it the highest incidence malignant tumor in the adult central nervous system. The incidence rate of grade 4 glioblastomas is about 4.03/100,000, accounting for 50.1% of all primary malignant tumors in the central nervous system. Glioblastomas are highly malignant, and despite current clinical treatment options including surgery, radiotherapy, and chemotherapy, patients have a short survival period. In the future, TLX101 is expected to become a pioneering treatment method in the field of glioblastoma therapy. According to research data from Bezos Consulting, the global market capacity for the treatment of glioblastoma 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 about 8.8%. If the development of GRAND PHARMA's TLX101 progresses smoothly in the future, it is expected to provide a new treatment option for glioblastoma and provide a new source of performance growth for the company. Continuously deepening the industrial layout of nuclear medicine and consolidating the leading position of global nuclear medicine enterprises In recent years, nuclear medicine has continued to receive market favor, coupled with the trend of pharmaceutical companies' layouts, the global market for radiopharmaceuticals is expected to further expand. According to data from the China Nuclear Safety Administration, the domestic market size of radiopharmaceuticals is expected to reach 9.3 billion RMB by 2025, and by 2030, the market size will increase to 26 billion RMB. As one of the first domestic companies to enter the nuclear medicine field, GRAND PHARMA has gradually entered the period of benefit release. For example, the company's flagship innovative product Yttrium [90Y] Microspheres, or TheraSphere, has continued to increase in volume since its launch, driving GRAND PHARMA's nuclear medicine sector to achieve revenue of nearly 600 million Hong Kong dollars in 2024, a year-on-year growth of nearly 177%. After years of cultivation, GRAND PHARMA has achieved a comprehensive layout in many aspects of research and development, production, sales, and regulatory qualifications in the field of nuclear medicine for anti-tumor treatment. In terms of products, the company currently has 13 innovative products in the research and registration stage, covering 5 radioactive isotopes including 68Ga, 177Lu, 131I, 90Y, and 89Zr, targeting 7 cancers including liver cancer, prostate cancer, kidney cancer, and brain cancer; in terms of product types, covering diagnostic and therapeutic nuclear medicine, providing patients with multiple indications for treatment options, and a comprehensive global leading anti-tumor solution. It is worth noting that GRAND PHARMA not only has a rich pipeline of RDC drugs, but most of them have the best potential in the same category, giving them a differentiated advantage compared to existing nuclear medicine. For example, take the innovative RDC product TLX591-CDx used for diagnosing prostate cancer. The product is expected to complete Phase III clinical trials in China by 2025, and after its launch overseas, it has achieved over 700 million US dollars in revenue in just two years, driving the stock price of GRAND PHARMA's important strategic partner Telix to continue to rise, with a increase of over 500% since the product was released and its market value once surpassing 10 billion US dollars. Currently, GRAND PHARMA has the most reserves of diagnostic and therapeutic RDC innovative drugs in Phase III clinical trials in China, and is one of the innovative drug companies with the most abundant product pipeline and a comprehensive layout in the field of nuclear medicine for anti-tumor treatment globally. With the active advancement of the company's innovative pipeline in clinical research and development, the process of product launch is expected to accelerate, indicating that in the future, GRAND PHARMA's innovative layout in the field of nuclear medicine for anti-tumor treatment will provide continuous strong driving force for the company's performance growth.