GP (HK)’s Two Global Innovative RDC Products Usher in a New Breakthrough, TLX591-CDx Dosed the First Patient in Japan; And TLX591 was Approved for Phase III Clinical Trials in Australia
(June 2, 2021 - Hong Kong) China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that Telix Pharmaceuticals Limited (ASX: TLX) (“Telix”), the Group’s partner in the field of radionuclide-drug conjugates (“RDC”), has successfully dosed the first patient for TLX591-CDx (Illuccix®, 68Ga-HBED-CC-PSMA11) (“TLX591-CDx”), the world’s innovative RDC for the imaging of prostate cancer, recently in Japan. TLX591 (177Lu-DOTA-Rosopatamab) (“TLX591”), a RDC for the treatment of prostate cancer, has been approved in Australia for Phase III clinical trials and has received ethical approval by Human Research Ethics Committee (HREC).
The Group always puts focus on the research and development (“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.
TLX591-CDx is a world’s innovative radionuclide-antibody conjugated diagnostic radiopharmaceutical product targeting prostate-specific membrane antigen (“PSMA”), for the diagnostics of metastatic prostate cancer and recurrent prostate cancer. After United States Food and Drug Administration (“FDA”) accepted the commercialization application in November 2020 and the priority review granted by the Australian Therapeutic Goods Administration (“TGA”) in December 2020, due to its significant clinical efficacy, safety and innovative superiority, it was included in the priority evaluation process by TGA in April 2021. It is currently the positron emission tomography (PET) diagnostic drug for prostate cancer base on 68Ga closest to be approved by FDA. Moreover, the marketing authorisation applications for TLX591-CDx in the European Union and Canada is also progressing actively.
The clinical trials of TLX591-CDx in Japan is a collaborative research conducted by Telix and Kanazawa University. The study will enroll ten patients with advanced prostate cancer to evaluate the safety of TLX591-CDx in Japanese population. This is the first clinical development of 68Ga-PSMA. The objective is to obtain the product’s safety data in Japanese population and demonstrate the targeting and biodistribution of the product is consistent with other international data. The clinical data facilitates Telix to discuss with Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and other Asian regulators on product development plans, meanwhile contribute to provide reference materials for registration and development in China. Clinical trials have shown that TLX591-CDx is an innovative positron-emitting radiopharmaceutical for diagnosis of prostate cancer with high sensitivity and specificity. The sensitivity and specificity of preoperative evaluation of patients with high metastasis risk are higher than that of conventional computed tomography imaging. PSMA imaging is already included in the leading clinical practice guidelines in the United States and Europe, based on evidence that definitively demonstrates superiority over conventional imaging. This is highly supportive of rapid promotion of TLX591-CDx upon approval for commercialization.
TLX591 (177Lu-DOTA-Rosopatamab) is a therapeutic radiopharmaceutical product targeting PSMA based on radionuclide-antibody conjugated technology, which has shown favorable safety and efficacy in the completed phase II clinical trials. The phase III clinical trials approved in Australia is an international, multi-centre, randomised controlledtrial. It will enroll 390 PSMA-positive patients with metastatic castrate-resistant prostate cancer (mCRPC) that have disease progression after previous treatment. The study will use TLX591-CDx detection technology to compare the therapeutic effect of TLX591 combined with standard therapy versus standard therapy alone, with a primary endpoint of radiographic progression-free survival (rPFS) and a secondary endpoint of overall survival (OS) and quality of life assessment.
According to data from the World Health Organization (WHO) in 2018, the standardized incidence rate of prostate cancer in China is 9.1 per 100,000. According to the the Chinese National Cancer Center in 2019 statistics showed that the incidence of prostate cancer in China has been rising recently and it is one of the cancer types with high incidence for males in China. In recent years, the incidence rate of tumors of urinary system has exhibited an upward trend. Due to the limited treatment options for metastatic prostate cancer, the 5-year survival rate of Chinese patients is significantly lower than that patients in United States. For recurrent metastatic castrate-resistant prostate cancer patients, there is still huge clinical needs for precise diagnosis and treatment.
The Group entered into agreement with Telix in November 2020, subscribed its certain equity interests for US$25 million, and obtained the exclusive rights of 6 global innovative RDC products including TLX591-CDx and TLX591 in Mainland China, Hong Kong SAR, Macau SAR and Taiwan, covering the diagnosis and treatment of prostate cancer, clear cell renal cell carcinoma and glioblastoma. The development of clinical study of TLX591-CDx in Japan facilitates accumulation of safety data for the product in Asian populations, demonstrates that the pharmacokinetics of the product are consistent with other international data, and lays a solid foundation for the product registration in China in the future. At the same time, the Phase III clinical trials of TLX591 in Australia will also accelerate commercialization process of the product.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “The smooth global development of the two radionuclide products of Telix deepens the competitive advantages of related products, and promotes the process of its commercialization. At the same time, it also reflects the precise vision of the Group’s strategic planning in the field of high-innovative and high-barrier nuclear medicine. Radionuclide drug is one of the key strategic directions in the field of anti-tumor. Looking forward, the Group will cooperate with major associate Sirtex Medical Pty Ltd and invested company Telix, to increase investment in and development of global innovative products in the field of radiopharmaceuticals in response to unmet clinical needs and enrich product pipeline and improve industrial layout, dedicating itself into building a world-leading radiopharmaceutical diagnosis and treatment platform.”