China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) announced that Telix Pharmaceuticals Limited (“Telix”), the Group’s partner in the field of radionuclide-drug conjugates (“RDC”), has successfully dosed the first patient in Phase I clinical study of TLX250-CDx (89Zr-DFO-girentuximab) (“TLX250-CDx”), a global innovative RDC for the treatment of clear cell renal cell carcinoma (“ccRCC”), on its expanding indication, urothelial carcinoma or bladder cancer, in Australia. According to the licensing agreement between the Group and Telix, the expanding indications for the product are also within the licensed scope that the Group has been granted. Moreover, the Group's self-developed product “Tadalafil Tablets” has been granted a drug registration certificate by the National Medical Products Administration of the People's Republic of China. The Group always puts focus on the R&D of innovative products and advanced technologies. Sticking to patients-centered and innovation-driven, the Group will continue to increase its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs and enrich product pipeline and improve supply chain. The Group adopts the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other. In this way, the Group can make full use of its industrial advantages and R&D capabilities, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world. TLX250-CDx is a global innovative diagnosis RDC drug based on radionuclide-antibody conjugated technology, which targeting on Carbonic anhydrase IX (“CA9”). CA9 is over-expressed in urologic malignancies. 89Zr is a positron nuclide with half-life about 78.4 hours and average positron energy 0.389MeV. 89Zr’s physical half-life is matched with the biological half-life of monoclonal antibody and its fragment, thereby is the ideal nuclide for positron emission computed tomography (“PET”) imaging. TLX250-CDx is suitable for the diagnosis of urologic malignancies. Given its possible breakthrough in the diagnosis and staging of the most common and most aggressive form of kidney cancer, ccRCC, TLX250-CDx has been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) in July 2020. Currently, the Phase III clinical study for the diagnosis of ccRCC is progressing smoothly. The clinical study of TLX250-CDx on the diagnosis of urothelial carcinoma or bladder cancer in Australia, is led by Professor Dickon Hayne at the Fiona Stanley Hospital in Perth, Australia. It will evaluate the feasibility of using TLX250-CDx and PET/CT to image CA9 for urothelial carcinoma or bladder cancer diagnosis and staging in 20 patients, and further explore CA9 as a therapeutic target for this type of patient. It is the first study that applies 89Zr to evaluate CA9’s degree of expression in cancers other than renal cancer, thus also lays the foundation for the expansion of clinical application of TLX250-CDx.