The IND of Grand Pharma’s Global Innovative RDC TLX250-CDx has been approved by NMPA

The IND of Grand Pharma’s Global Innovative RDC TLX250-CDx has been approved by NMPA

  • TLX250-CDx is a globally innovative radionuclide conjugated drug for the diagnosis of urological malignant tumors. Its target is carbonic anhydrase IX which is overexpressed in urological malignancies;
  • TLX250-CDx was granted Breakthrough Therapy Designation by the U.S. FDA in July 2020. Its overseas phase III clinical study has completed the recruitment of all 300 subjects in July 2022, and is expected to complete the study and report the results in the second half of 2022;
  • The Group has reserved 13 innovative products in its nuclear medicine anti-tumor diagnosis and treatment segment, covering 6 nuclides as well as 8 cancers.

(September 28, 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 TLX250-CDx (for the diagnosis of clear cell renal cell carcinoma (“ccRCC”)) obtained implied approval (Class I new drug) 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.

TLX250-CDx is a globally innovative radionuclide conjugated drug for the diagnosis of urological malignant tumors. Its target is carbonic anhydrase IX (“CA9”). CA9 is overexpressed in urological malignancies. TLX250-CDx was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in July 2020 based on its important breakthroughs in non-invasive diagnosis for the most common and aggressive type of kidney cancer - ccRCC as well as the patients’ follow-up treatment and management decisions. The overseas phase III clinical study has completed the recruitment of all 300 subjects in July 2022, and is expected to complete the study and report the results in the second half of 2022.

Among the Phase I clinical trial and the confirmatory clinical trial of TLX250-CDx approved in China this time, the Phase I clinical trial aims to evaluate the safety, radiation dosimetry and pharmacokinetic characteristics of the product in patients with indeterminate renal masses or suspected recurrent ccRCC; and the confirmatory clinical trials will evaluate the safety and tolerability of the product in the diagnosis of ccRCC by non-invasive detection of PET/CT imaging in patients with indeterminate renal masses, and to evaluate the sensitivity and specificity of TLX250-CDx based on histological diagnosis for supporting the commercialization application of the product 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 products is an 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 radiopharmaceutical diagnosis and treatment platform with a dual-system development path of local + global R&D and production.”