NDA for Y-90 Resin Microspheres of GP(HK) Accepted by NMPA and NDA for Prostate Cancer Imaging RDC Product TLX591-CDx Accepted by FDA, Actively Promote the Commercialization Process of Innovative Products and Expand Strategic Planning in the Field of Radiopharmaceuticals
(November 25, 2020, 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 the Group’s subsidiary Grand Pharma (China) Co., Ltd. (“Grand Pharma (China)”) and the Group’s associate Sirtex Medical Pty Ltd (“Sirtex”) submitted new drug application (“NDA”) for the world’s innovative product SIR-Spheres® Y-90 resin microspheres to the National Medical Products Administration of the PRC (“NMPA”) and got formally accepted. SIR-Spheres® Y-90 resin microspheres is one of the Group's blockbuster products in precision interventional therapy and anti-tumor radioactive pharmaceuticals. Meanwhile, Telix Pharmaceuticals Limited (ASX: TLX) (“Telix”), the Group’s partner in the field of radionuclide-drug conjugates (“RDC”), has submitted the NDA for TLX591-CDx (68Ga-HBED-CCPSMA11) (“TLX591-CDx”), the world’s innovative RDC product for the imaging of prostate cancer. The NDA has been recently accepted for filling by the United States Food and Drug Administration (“FDA”), and it is expected to receive the outcome of the request for priority review on 10 December 2020, with the expectation of shortening the time for US approval for commercialization through priority review.
The Group adopts the strategy of “global expansion and dual-cycle operation”, and regards anti-tumor radiopharmaceuticals and precision interventional therapy as one of the focus areas in future strategic planning, gradually forming a new pattern of domestic and international cycles that synergize with each other. At present, the Group has obtained seven innovative first-in-class RDC including Y-90 resin microspheres and TLX591-CDx in the field of radioactive pharmaceuticals, for diagnostics and treatment of prostate cancer, clear cell renal cell carcinoma and glioblastoma. In the field of precision interventional therapy, TAVOTM, the core product of OncoSec Medical Incorporated (NASDAQ: ONCS) (“OncoSec”, an associate of the Group), the Group’s research and development platform in tumor immunotherapy and DNA technology, are undergoing clinical trials in treating metastatic melanoma, triple-negative breast cancer and squamous cell tumors, having shown satisfactory effectiveness. The Group so far has owned 11 innovative products globally, covering 8 major solid tumors. The variety and quantity of the Group’s product pipeline are at the leading level in this industry.
Y-90 resin microspheres is the only radioactive microspheres around the world approved by the FDA, which are used in selective internal radiation therapy for malignant liver tumors, and has the dual advantages of radiopharmaceuticals and precision interventional therapy. A number of high-quality and large-sample clinical studies on Y-90 resin microspheres have been carried out in Europe, US, Hong Kong and Taiwan, and the results prove that Y-90 resin microspheres can significantly increase response rate, reduce tumor burden and achieve tumor downstaging, so that patients can gain the chances to undergo surgical resection. It can also significantly prolong the progression-free survival, control tumor progression and increase the waiting time for liver transplantation. In the meantime, Y-90 resin microspheres bring less side effects and higher quality of life for patients.
Y-90 resin microspheres has been given to over 100,000 people in 50 countries and regions around the world. With its remarkable clinical efficacy, it has been covered by medical insurance in places such as the United States and Europe. It is also recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (“NCCN”) and European Society for Medical Oncology (“ESMO”). In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition) with clear clinical demands delineated. Y-90 resin microspheres will provide new treatment option to hundreds of thousands of cancer patients in China after being launched to the market.
TLX591-CDx is a world’s innovative radionuclide-antibody conjugated diagnostic radiopharmaceutical product targeting prostate-specific membrane antigen (“PSMA”), for diagnostics of metastatic prostate cancer. It is currently the fastest RDC project under development using Positron Emission Tomography (“PET”) for the imaging of prostate cancer, expected to be the first approved radiopharmaceutical product by the FDA. 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.
The 2020 edition of NCCN guidelines for prostate cancer recommends TLX591-CDx as a new type of positron-emitting radiopharmaceutical (“PET Tracer”), which may provide better detection of recurrences at lower prostate-specific antigen (“PSA”) levels than approved imaging agents.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: “The FDA has accepted NDA for TLX591-CDx and is likely to be granted priority review next month, together with NDA for the world’s innovative product SIR-Spheres® Y-90 resin microspheres being formally accepted by the NMPA, which further demonstrates the Group’s capabilities of selecting world-class innovative products, precise and powerful business development capabilities at home and abroad as well as ability to introduce and fully implement international advanced technologies.”
“Looking ahead, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including US based OncoSec, Australia based Sirtex and Telix, the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and precision interventional platform integrating diagnostics and treatment. Meanwhile, the Group makes full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products and provide Chinese cancer patients with more advanced and diverse treatment options.”