The IND of Grand Pharma’s Global Innovative RDC TLX591-CDx has been approved by NMPA

The IND of Grand Pharma’s Global Innovative RDC TLX591-CDx has been approved by NMPA

  • TLX591-CDx is a globally innovative, radionuclide-small molecule conjugated technology-based diagnostic radiopharmaceutical targeting PSMA, suitable for the diagnosis of metastatic and recurrent prostate cancer;
  • TLX591-CDx was approved for commercialization in the United States, Australia and Canada, and was specially authorized in Brazil to allow sales prior to the official approval. It also submitted commercialization applications in 16 countries;
  • The results of a phase I trial in Japan in February 2022 showed that TLX591-CDx was safe and well tolerated. No serious adverse events were observed among all subjects, and no significant differences between Japanese and Western races.

(October 17, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the investigational new drug (IND) application for the Group’s radionuclide-drug conjugate (“RDC”) drug TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11, for the diagnosis of prostate cancer) obtained implied approval from the National Medical Products Administration of the People’s Republic of China (“NMPA”) recently. It is an important progress of localizing the Group’s nuclear medicine anti-tumor diagnosis and treatment platform in China.

TLX591-CDx is a globally innovative, radionuclide-small molecule conjugated technology-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 has five characteristics, including internalization into cells, stable biological activity, short circulation half-life in vivo, good permeability to tumor parenchyma, and rapid clearance by non-targeted tissues.

Previously, this product was approved for commercialization in Australia in November 2021. In December of the same year, it was approved for commercialization in the United States and was specially authorized in Brazil to allow sales prior to the official approval. And it was approved for commercialization in Canada in October 2022. At the same time, it also submitted commercialization applications in 16 countries. 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 races.

This time the IND application submitted by the Group in China is a clinical bridging study of the product in the Chinese population. TLX591-CDx will be used in more than 100 patients with biochemical recurrence after radical prostatectomy and/or radical radiotherapy, and Positron Emission Tomography/Computed Tomography (PET/CT) or Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) tests to evaluate the diagnostic effectiveness of products in patients with biochemical recurrence of prostate cancer. At the same time, it will evaluate the safety and tolerability of the product in the Chinese population, and provides support for the product 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, covering 6 nuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr and 99mTc as well as 8 cancers including liver cancer, prostate cancer and brain cancer. In terms of product types. It covers two types of radionuclide drugs for diagnosis and treatment, providing patients with multi-indication treatment options, multi-method and integrated diagnosis and treatment of the world’s leading anti-tumor solutions. At the same time, the Group and Shandong University jointly established Grand Pharma - Shandong University Radiopharmaceutical Research Institute (遠大醫藥-山東大學放射藥物研究院) to jointly carry out the R&D of RDC drugs on the basis of radionuclide research by the Laboratory Nuclear Medicine Research Institute (實驗核醫學研究所) of Shandong University.

The nuclear medicine anti-tumor diagnosis and treatment platform is the Group’s high-end technology platform in the field of anti-tumor. The Group has achieved a comprehensive strategic plan in the fields of R&D, production, sales, regulatory qualifications and established a complete industrial chain. The Group, together with Sirtex Medical Pty Limited, cooperated with Telix Pharmaceutical Limited (ASX: TLX) and ITM Isotope Technologies Munich SE to establish a world-class tumor intervention R&D platform and a radionuclide-drug conjugate R&D platform. It has more than 400 employees, with approximately 35% of them holding master’s degrees and doctoral degrees, and is one of the most globalized segments of the Group. The Group has become a leading enterprise in nuclear medicine anti-tumor diagnosis and treatment in China.

In the next 1 to 2 years, the Group will continue to strengthen the R&D and investment in the nuclear medicine anti-tumor diagnosis and treatment segment, enrich and improve the product pipeline and industrial layout, establish at least one production platform with Grade A qualification in China, realize the pipeline layout of more than twenty-five nuclear medicine anti-tumor diagnosis and treatment products, form a nuclear medicine anti-tumor diagnosis and treatment product cluster with the core of Yttrium-90 microsphere injections.

The Board of Grand Pharmaceutical Group Limited, commented, “The approval of IND of the innovative RDC product TLX591-CDx is another important progress of localizing the Group’s nuclear medicine anti-tumor diagnosis and treatment platform in China. In the future, the Group will continue to increase investment and development of global innovative products in the field of radionuclide diagnosis and treatment drugs for unmet clinical needs, enrich and improve product pipelines and industrial strategic plan, constantly enhance the Group’s global R&D strength in this field, make contribution to the development of radiopharmaceutical industry in China, and strive to build an internationally leading nuclear medicine anti-tumor diagnosis and treatment platform with a dual-system development path of local + global R&D and production.”