The Board of Grand Pharmaceutical Group Limited announced that the Phase III clinical trial conducted by the Group of TLX591-CDx (Illuccix®?, gallium Ga 68 PSMA-11), an innovative radionuclide-drug conjugate ("RDC") for the diagnosis of prostate cancer, in China has completed the first patient enrollment and dosing recently. The study is a single-arm, open-label Phase III clinical study. It is planned to use TLX591-CDx and perform Positron Emission Tomography/Computed Tomography (PET/CT) or Positron EmissionTomography/Magnetic Resonance Imaging (PET/MRI) detection in more than 100 patients with biochemical recurrence after radical prostatectomy and/or radical radiotherapy, to evaluate the diagnostic effectiveness of the product, and at the same time, to evaluate the safety and tolerability of the product in the Chinese population.

The Group has exclusive licenses of this product in Mainland China, Hong Kong SAR, Macau SAR and Taiwan, and the first patient enrollment and dosed in this Phase III clinical trial is another important research and development progress of the Group in the field of nuclear medicine anti-tumor diagnosis and treatment. TLX591-CDx is a globally innovative, radionuclide-small molecule based diagnostic radiopharmaceutical targeting prostate-specific membrane antigen ("PSMA"), suitable for the diagnosis of metastatic and recurrent prostate cancer. The targeting agent PSMA-11 in TLX591-CDx can specifically bind to PSMA in prostate cancer in a high-affinity manner.

It was also approved for commercialization in Canada in October 2022. Marketing authorisation applications for this investigational candidate are currently progressing in the United Kingdom and the European Union. In terms of clinical research, TLX591-CDx completed a Phase I trial in Japan in February 2022, which included 10 subjects.

The results of the study showed that TLX591-CDx was safe and well tolerated. No serious adverse events were observed among all subjects, and systemic and organ-specific radiation dosimetry and pharmacokinetic data showed no significant differences between Japanese and Western patients. The first patient enrollment and dosing in this Phase III clinical trial will further accelerate the process of the product's commercialization in China.

By adhering to the treatment concept of integrated oncology diagnosis and treatment, the Group has reserved 13 innovative products in its nuclear medicine anti-tumOR diagnosis and treatment segment, including 6 radionuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr and 99mTc and covering 8 cancers including liver cancer, prostate cancer and brain cancer. (Yi Gan Tai ®?) Yttrium-90 resin microsphere injections ("YiGanTai") has been granted approval for commercialization by the National Medical Products Administration of the People's Republic of China in January 2022. The product provides a new and effective treatment modality for patients with liver malignancies in China, offering the opportunity for translational therapy and further surgical resection to achieve clinical cure, bridging the gap in the local treatment of liver metastases from colorectal cancer, improving the long-term treatment outcome of the Chinese patient population with liver cancer, and marking the arrival of a new international precision interventional treatment option in the field of liver malignancies in China.

Since the official commercialization of YiGanTai in May 2022, more than 60 hospitals have completed the nuclide transfer procedures, its official surgeries have been carried out in more than 40 hospitals in 17 provinces and cities in China. Among them, the symptoms of more than 30 patients were completely relieved with no resection required, and the disease control rate of the follow-up patients exceeded 70%, showing a remarkable therapeutic effect. In order to speed up the implementation and popularization of YiGanTai microsphere precise interventional therapy in China, the Group relied on the high-quality reputation and practical experience accumulated overseas for the product over the years, assisted domestic doctors in conducting multiple personalized practical trainings by well-known overseas clinical experts.

At present, it has trained more than 400 doctors in 70 hospitals on the theory or skills of YiGanTai surgery, nearly 20 experts in 70 hospitals on the theory and skills of YiGanTai Surgery, nearly 20 experts have obtained the theory or skills of Yi GanTai surgery, nearly 20 professionals of YiGanTai surgery. At present, nearly 20 experts have obtained The Group on the theory or skills ofYGanTai surgery, nearly 200 experts. At present, nearly 20 professionals of Yi G&&&&&&&A surgery, nearly 20 experts.

At present, nearly 200 experts have obtained the theory or capabilities of YiGanTai surgery and skills of YiGan Tai surgery, nearly 20 experts of YiGanTai surgery.