The nuclear medicine sector has made further progress! GRANDPHARMA (00512) completed the first patient dosing in the global innovative TLX591 phase III clinical trial for prostate cancer treatment overseas, continuing to solidify its leading position in nuclear medicine.

Recently, Hong Kong's technology innovation pharmaceutical company GRANDPHARMA (00512) has received positive news. The overseas Phase III clinical trial (ProstACT GLOBAL) of the global innovative drug TLX591 (177Lu-rosopatamab tetraxetan) in the field of radiolabeled drugs coupled with nucleotides has completed the dosing of the first patient. TLX591 is a therapeutic radiopharmaceutical based on radiolabeled-antibody conjugation technology that targets prostate-specific membrane antigen (PSMA). The ProstACT GLOBAL, which completed the dosing of the first patient, is an international, multicenter, prospective, randomized, controlled, open-label Phase III clinical trial that plans to recruit approximately 400 patients. ProstACT GLOBAL is the first evaluation of the benefits and risks of SOC combined with TLX591 dosing compared to SOC alone in adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Previously, TLX591 has completed a total of 8 Phase I and II clinical trials, including ProstACT SELECT, treating a total of 242 patients, confirming the clinical efficacy and safety of the optimal dosing regimen. Preliminary data from the ProstACT SELECT study showed that PSMA has a high tumor-targeting ability and minimizes uptake and toxicity issues in organs such as the kidneys. It also demonstrated the longer drug retention time, absorption rate, and potential efficacy benefits of 177Lu-labeled PSMA antibody targeted therapy. In addition, ProstACT GLOBAL plans to expand internationally and obtain approvals from regulatory authorities including Europe and the United States. The submission of a new drug clinical trial application (IND) to the US FDA is currently being prepared according to plan, and mid-term data analysis is expected to be conducted after treatment in the first 120 patients. It is worth noting that TLX591, together with GRANDPHARMA's other global innovative radiolabeled drug TLX591-CDx (Illuccix), forms a combined therapeutic and diagnostic solution for metastatic castration-resistant prostate cancer. The sales of Illuccix after its launch have achieved unexpected growth - the sales revenue in the third quarter of this year was approximately AUD 130 million (approximately CNY 610 million), with a quarter-on-quarter growth of about 13% and a year-on-year growth of nearly 143%. The product's sales revenue in the United States for the first three quarters of this year totaled approximately AUD 340 million (approximately CNY 1.6 billion). With the continuous development of TLX591's global research and development, it is also expected to bring new performance growth momentum to the company in the future. Continuing to practice differentiated innovation development strategy to solidify the leading position in the nuclear medicine field It is reported that nuclear medicine anti-tumor diagnosis and treatment is one of the key areas of GRANDPHARMA's layout. The company has achieved comprehensive layout in multiple aspects such as research and development, production, sales, and regulatory qualifications in the nuclear medicine anti-tumor field, establishing a complete industrial chain. The nuclear medicine sector of the company has more than 400 employees, with nearly 40% having master's or doctoral degrees. It is one of the sectors with the highest level of globalization in GRANDPHARMA. Based on the concept of integrated treatment of tumor diagnosis and treatment, the company currently has 13 innovative products in the nuclear medicine anti-tumor diagnosis and treatment field, covering 6 radiolabeled nucleotides and 8 types of cancer. The product range covers both diagnostic and therapeutic drugs, providing patients with multiple indications treatment options and a globally leading integrated approach to anti-tumor treatment. As the core product of the nuclear medicine anti-tumor diagnosis and treatment sector of GRANDPHARMA, Yttrium-90 microsphere injection (Y-90) -YGOTAN officially launched in China in May 2022. More than 60 hospitals have completed the transfer of nucleotides, and the product's official operations have been carried out in more than 40 hospitals in 17 provinces and cities in China. Follow-up results show that patients who have undergone Y-90 surgery have overall positive responses, and most patients have achieved good clinical efficacy and extended survival. The disease control rate of the followed-up patients exceeds 70%, and more than 30 patients have complete symptom relief without the need for resection, demonstrating significant treatment effects. On the other hand, the research and development of the company's innovative radiolabeled drug pipeline has also made progress recently. TLX591-CDx for prostate cancer diagnosis completed the dosing of the first patient in Phase III clinical trials in China; TLX250-CDx for renal clear cell carcinoma diagnosis completed the dosing of the first patient in Phase I clinical trials in China; TLX101 and ITM-11 have been approved for domestic clinical trials, and multiple innovative products are advancing in clinical trials simultaneously. GRANDPHARMA stated that the company has always attached great importance to the research and development of innovative products and advanced technologies, and will continue to strengthen the research and investment in the nuclear medicine anti-tumor diagnosis and treatment sector. The company aims to have 10 nuclear medicine products enter the clinical stage within the next three years, establish a pipeline layout of more than 25 nuclear medicine anti-tumor diagnosis and treatment products, and form a cluster of nuclear medicine anti-tumor diagnosis and treatment products with Y-90 microsphere injection (Y-90) -YGOTAN as the core, continuously consolidating the company's leading position as a global leader in nuclear medicine anti-tumor diagnosis and treatment.