GP (HK)’s Global Innovative RDC Drug TLX591-CDX Was Approved in The United States, Another Milestone Progress of the Group’s Innovative Products’ Commercialization

GP (HK)’s Global Innovative RDC Drug TLX591-CDX Was Approved in The United States, Another Milestone Progress of the Group’s Innovative Products’ Commercialization

(December 21, 2021 - Hong Kong) Grand Pharmaceutical Group Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that a global innovative radionuclide-drug conjugates (“RDC”) product TLX591-CDx (Illuccix®, 68Ga-HBED-CC-PSMA11) for prostate cancer imaging from Telix Pharmaceuticals Limited (ASX: TLX, the Group owned 7.35%), an important strategic partner of the Group in the field of RDC, has recently been officially approved by the Food and Drug Administration (“FDA”) of the United States.

Radionuclide drug is one of the strategic directions of the Group in the field of nuclear medicine and gene intervention therapy for anti-tumor. SIR-Spheres® Y-90 resin microspheres, a radionuclide drug of the Group for the treatment of liver cancer, is expected to be approved by the end of this year or next year and officially launched in Mainland China. In the future, the Group will cooperate with its associate company Sirtex Medical Pty Ltd and its invested company Telix to increase the investment and development of global innovative products in the field of radiopharmaceuticals to meet unmet clinical needs, enrich product pipelines and improve industrial strategic plan.

TLX591-CDx is a globally innovative radionuclide-antibody conjugated diagnostic radiopharmaceutical product targeting prostate-specific membrane antigen (“PSMA”), for the diagnosis of metastatic and recurrent prostate cancer. The targeting agent PSMA11 in TLX591-CDx can specifically bind to the high-expressed PSMA in prostate cancer with high affinity. It has five characteristics including the ability to be internally incorporated into cells, stable biological activity, short circulation half-life in vivo, good permeability to tumour cells and can be quickly eliminated by non-targeted tissues.

PSMA imaging has been included in the clinical practice guidelines of the United States and Europe. The “CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer (2020)” also recommended the use of PSMA imaging for the diagnosis of recurrent prostate cancer, fully reflects the superiority of PSMA imaging which laid a foundation for the rapid commercialization for TLX591-CDx after be approved. The NDA progress of TLX591-CDx in the European Union and Canada is also active.

The registration of TLX591-CDx in China is progressing steadily and it is expected to submit the investigational new drug application (IND) to the China National Medical Products Administration (NMPA) in the first quarter of 2022. The FDA's approval this time and the clinical research in Japan in June this year that accumulates the safety data of Asian populations will further lay a solid foundation for the product's registration in China.

Prostate cancer is one of the most common male cancers. According to “GLOBOCAN 2020”, the number of global prostate cancer incidences will exceed 1.4 million and the death toll will exceed 370,000 in 2020, while the number of prostate cancer incidences in China will exceed 110,000 and the death toll is more than 50,000. The morbidity is about 10.2 per 100,000, and it is increasing year by year.

At present, the most effective treatment for localized prostate cancer is radical resection, but the biochemical recurrence rate is as high as 17% to 53% after surgery within 10 years. The standard treatment for metastatic prostate cancer is androgen deprivation treatment (ADT), but 86% of patients will eventually develop to metastatic castration-resistant prostate cancer. There is no effective clinical treatment and the prognosis is poor. Therefore, early diagnosis of recurrence or metastasis prostate cancer is significant to the success of salvage treatment.

Currently, the main diagnostic methods for recurrent and metastatic prostate cancer are serum prostate-specific antigen (“PSA”) test, computer tomography (“CT”) and magnetic resonance imaging (“MRI”) which all have some deficiencies in specificity and sensitivity. These methods cannot fully meet the current clinical needs.

The 2020 edition of National Comprehensive Cancer Network (NCCN) prostate cancer guideline recommended TLX591-CDx as a new positron-emitting radiopharmaceutical (“PET Tracer”) tracer, which is more effective than other approved tracers in detecting recurrence in patients with low PSA levels. The clinical trials have shown that TLX591-CDx is a new type of positron radiopharmaceuticals with high accuracy and sensitivity for the diagnosis of prostate cancer. Its sensitivity and accuracy are higher than that of conventional CT in the preoperative evaluation of patients with high metastasis risk. At the same time, the detection rate and dominance rate of TLX591-CDx for the recurrence of prostate cancer are significantly better than the radioactive PET tracer 18F-Fluciclovine PET-CT for the recurrence of prostate cancer.

The Board of Grand Pharmaceutical Group Limited, commented, “TLX591-CDx was approved by FDA of the United States is an important milestone of the Group's global deployment in the field of RDC drugs and anti-tumor, and lay a solid foundation for the product's registration in China. Looking ahead, the Group will continue to adopts the strategy of ‘global expansion and dual-cycle operation’ continuously increase the investment and development of global innovative products in the field of radiopharmaceuticals, enrich and improve product pipelines and industrial strategic plan, and strive to build an international leading radiopharmaceutical diagnosis and treatment platform."