The progress of core pharmaceuticals is surging! GRAND PHARMA (00512) innovation RDC drug TLX591-CDx domestic Phase III reached major clinical endpoints, and the layout of diagnosis and treatment integration is ready to take off.

GRAND PHARMA's nuclear medicine pipeline is in full swing! Following the FDA approval of the company's self-developed global innovative FAP-targeted radiopharmaceutical (RDC) GPN01530 in phase I/II clinical trials in the United States, GRAND PHARMA has once again reported good news on December 21st - the innovative RDC drug TLX591-CDx used for diagnosing prostate cancer has achieved positive top-line results in phase III clinical trials conducted in China, successfully meeting the primary clinical endpoints. This also means that TLX591-CDx is about to enter the new drug application phase, bringing the commercialization expectations closer to reality. The nuclear medicine sector has made significant progress one after another, not only deepening GRAND PHARMA's product layout blueprint based on nuclear medicine diagnosis and treatment integration, but also reflecting the company's stage progress in the global layout of the nuclear medicine industry, with continuous enhancement of its global core competitiveness in the nuclear medicine field. TLX591-CDx's clinical data superiority is significant, with a poised nuclear medicine combination for diagnosis and treatment According to the announcement, TLX591-CDx is a globally innovative diagnostic radiopharmaceutical targeting the prostate-specific membrane antigen (PSMA) based on radiopharmaceutical-small molecule conjugation technology, suitable for diagnosing initial and recurrent prostate cancer. Public data shows that the targeting agent PSMA-11 in TLX591-CDx can specifically bind to PSMA highly expressed in prostate cancer in a highly specific and stable manner, with five major features of high affinity, specific cell internalization, stable biological activity, short in vivo circulation half-life, good penetration into tumor tissue, and rapid clearance from non-target tissues. According to the top-line results of this clinical trial, TLX591-CDx demonstrated a high level of diagnostic accuracy, with an overall positive predictive value (PPV) for detecting tumors reaching 94.8%, and a PPV of 100.0% for recurrent prostate bed and non-bone metastatic tumors. At the same time, for bone metastasis and patients with different baseline levels of prostate-specific antigen (PSA), TLX591-CDx also showed high PPV. The excellent clinical results indicate that TLX591-CDx's PET imaging detection has very positive clinical significance for the early diagnosis of suspected biochemical recurrence in prostate cancer patients, potentially providing earlier indication of disease progression and striving for a valuable treatment time window for patients. In addition, more than two-thirds of patients had adjustments to their treatment plans compared to the initial baseline treatment plan after undergoing PET imaging detection with TLX591-CDx, demonstrating that the product's PET imaging detection has an important impact on clinical decision-making, optimizing the clinical treatment strategy for prostate cancer patients with suspected biochemical recurrence. This significant and outstanding clinical research result not only fully confirms the high accuracy and clinical utility of TLX591-CDx in prostate cancer diagnosis, but also provides solid evidence for its subsequent new drug application in China. In fact, the commercial potential of TLX591-CDx has been verified by its outstanding performance in the global market. The product has been approved for marketing in several countries including the United States, Australia, Canada, Brazil, and the United Kingdom. According to public data, TLX591-CDx achieved sales of approximately 517 million US dollars in 2024; sales in the first three quarters of 2025 reached approximately 461 million US dollars, with a year-on-year growth of over 25%. This strong sales performance provides strong support for its commercial prospects in the Chinese market. It is worth noting that the success of the phase III clinical trial of TLX591-CDx in China also means that GRAND PHARMA has taken a key step in building an integrated diagnosis and treatment prostate cancer nuclear medicine product portfolio - in the field of prostate cancer treatment, the company's another innovative RDC product TLX591 has been approved to join international multicenter phase III clinical trials in China, and from the clinical results standpoint, the product has shown clinical potential beyond existing anti-PSMA peptide RLT molecules, with the potential to redefine the treatment standards for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer is a common type of cancer in the male population in China, and with reasons such as aging population, the incidence and mortality rates of prostate cancer patients in China have been significantly increasing. According to Frost & Sullivan data, by 2030, the incidence of prostate cancer in China may exceed 165,000 cases, and during the same period, the market size of prostate cancer drugs in China is expected to reach approximately 37.6 billion RMB. In the future, the above two GRAND PHARMA integrated diagnosis and treatment products are poised to bring more precise and efficient diagnosis and treatment solutions for Chinese prostate cancer patients, significantly improving the quality of life for patients, and will form a strong synergistic effect in the commercial aspect, unleashing huge market value and consolidating GRAND PHARMA's comprehensive advantages in the nuclear medicine field. Advantages of full industrial chain layout highlighted, contributing to the global nuclear medicine "Chinese power" The breakthroughs in the field of nuclear medicine are the inevitable result of GRAND PHARMA's years of deep cultivation in this field. Currently, the company has achieved a comprehensive layout in multiple aspects such as research and development, production, distribution, and sales in the nuclear medicine anti-tumor diagnosis and treatment sector. With research centers in Boston and Chengdu as the core, production facilities in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering more than 50 countries and regions worldwide, the company has realized a global layout of the nuclear medicine industry chain. In terms of product pipeline, focusing on the treatment concept of integrated cancer diagnosis and treatment, GRAND PHARMA has already reserved 16 innovative products in the research and registration stage, covering five radiopharmaceuticals including 68Ga, 177Lu, 131I, 90Y, and 89Zr, covering seven types of cancers including liver cancer, prostate cancer, brain cancer, among others; in the early stage of research and development, focusing on RDC drugs, with more than 10 products reserved, covering both diagnostic and therapeutic nuclear medicine variety, providing patients with multiple indications for treatment selection, and global leading anti-tumor solutions with multiple means and integrated diagnosis and treatment. Currently, GRAND PHARMA has six innovative RDC products approved to conduct registration clinical studies, four of which have entered phase III clinical trials, signifying that the company has entered the harvest period of innovative nuclear medicine products. In July of this year, SIR-Spheres yttrium [90Y] microsphere injection (YiGantai) was formally approved in the United States for the treatment of unresectable HCC, and in September of this year, it obtained the CE mark certification in Europe for additional indications in multiple liver cancer types, becoming the world's first and only selective internal radiation therapeutic product approved by the FDA for dual indications of unresectable HCC and colorectal cancer liver metastases, expanding its market space to a strategic level. In addition, the company's self-developed innovative radiopharmaceutical targeting glypican-3 (GPC-3) GPN02006 based on radiopharmaceutical-antibody conjugation technology for diagnostic radiopharmaceuticals has achieved a milestone breakthrough in the investigator-initiated clinical study (IIT clinical study) conducted in China, and won an oral presentation at the 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, positioning itself to become the world's first RDC product targeting GPC-3 in hepatocellular carcinoma (HCC). Especially worth mentioning is the company's self-developed global innovative FAP-targeted small molecule RDC drug GPN01530, which recently received FDA approval to conduct phase I/II clinical trials for diagnosing solid tumors in the United States. This product is the company's first self-developed RDC product to obtain FDA approval for clinical research, and based on preclinical research results, GPN01530 has the potential to be "the best in class", and is expected to provide a new tumor diagnostic solution in the future, paving the way for a paradigm shift in the international development of the company's nuclear medicine product pipeline, while demonstrating the outstanding pre-clinical development and international registration capabilities of the company's nuclear medicine technology platform. In terms of industrial layout, GRAND PHARMA has also made fruitful achievements, continuously strengthening its "moat" in the field of nuclear medicine - the company's nuclear medicine research and production base in Chengdu, Sichuan is the world's first closed-loop platform for the full industrial chain of nuclear medicine, establishing a closed-loop system covering the entire chain of "research and development-production-sales", truly achieving complete autonomous controllability in the research, production, and sales of innovative nuclear medicine products. It is reported that this base obtained a Grade A "Radiation Safety License" in May 2025, and officially started operations in June of this year, being one of the most comprehensive and highly automated intelligent factories in the world in terms of nuclear isotopes, capable of fully meeting the diverse and large-scale production requirements of the company's therapeutic and diagnostic nuclear medicines. In the future, as the global nuclear medicine market continues to expand, GRAND PHARMA is expected to leverage its first-mover advantage and full industrial chain capabilities to further implement its "Go Global" development strategy, expanding the company's share in the global nuclear medicine market, providing higher-quality diagnosis and treatment solutions for global cancer patients, and promoting greater breakthroughs in China's nuclear medicine industry on the global stage, becoming an indispensable "Chinese power" in the global nuclear medicine field.