The IND of Grand Pharma’s Global Innovative RDC TLX591-CDx and TLX250-CDx has been accepted by NMPA

The IND of Grand Pharma’s Global Innovative RDC TLX591-CDx and TLX250-CDx has been accepted by NMPA

  • TLX591-CDx is commercialized in the United States, Australia, etc. The results of phase I trial in Japan completed in February 2022 showed that it was safe and well tolerated, and no serious adverse events were observed in all subjects.
  • TLX250-CDx was granted Breakthrough Therapy Designation by the 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’s radiopharmaceutical diagnosis and treatment platform now has 10 products, covering 6 nuclides, and its indication covers multiple caner types.

(August 1, 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 conjugates (“RDC”) drug TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11) for the diagnosis of prostate cancer, and the drug TLX250-CDx (89Zr-DFO-girentuximab) for the diagnosis of clear cell renal cell carcinoma (“ccRCC”) have been officially accepted by the National Medical Products Administration of the People’s Republic of China (“NMPA”) recently. It is an important progress of localizing the Group’s radionuclide drug diagnosis and treatment platform in China.

Radionuclide diagnosis and treatment drug is one of the strategic directions of the Group in anti-tumor field. It has achieved a comprehensive strategic plan in the fields of research, production and commercialization worldwide and has built up a complete industrial chain. The Group established international first-class R&D platform for tumor intervention and R&D platform RDC, cooperating with its associate company Sirtex Medical Pty Ltd, its invested company Telix Pharmaceuticals Limited (ASX: TLX) and ITM Isotope Technologies Munich SE.

The radiopharmaceutical diagnosis and treatment platform of the Group currently has 10 products, covering 6 nuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr, 99mTc. Among them, SIR-Spheres® Y-90 resin microsphere is the first radioactive microsphere product approved by FDA and was approved for commercialization in China on 30 January 2022. The Group’s radionuclide drug pipeline is rich and covers a wide range of cancer types. In terms of indications, it covers liver cancer, prostate cancer, clear cell renal cell carcinoma, glioblastoma, gastroenteropancreatic neuroendocrine tumors and bone metastases of malignant tumors. 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 present, the radiopharmaceutical diagnosis and treatment platform of the Group and its associates have more than 400 employees worldwide, nearly 40% of them hold master or doctorate degrees; three radiopharmaceutical R&D bases and five radiopharmaceutical production bases are set around the world, and the radiopharmaceutical diagnosis and treatment platform is currently one of the most globalized segments of the Group.

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.

TLX-591CDx 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. At the same time, it also submitted commercialization applications in 17 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 Positive Electron 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.

TLX250-CDx is also a globally innovative diagnostic radionuclide conjugated drug based on radionuclide-antibody conjugate technology. It is suitable 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.

The phase I clinical trial of TLX250-CDx filed in China aims to evaluate the safety, radiation dosimetry and pharmacokinetic characteristics of the product in 10 patients with indeterminate renal masses or suspected recurrent ccRCC; China 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 98 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.

The Board of Grand Pharmaceutical Group Limited, commented, “The acceptance of the INDs of the Group’s two RDC products by the NMPA is an important progress for the landing of the Group’s radionuclide drug diagnosis and treatment platform in China, and will also lay the solid foundation for the commercialization of the products in China.

Looking forward, the Group will 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.”