Grand Pharma Entered into an Equity Investment Agreement with ITM in Germany, Further Consolidate the Group’s Comprehensive Industrial Chain Layout in Research, Production and Commercialization of Radionuclides

Grand Pharma Entered into an Equity Investment Agreement with ITM in Germany, Further Consolidate the Group’s Comprehensive Industrial Chain Layout in Research, Production and Commercialization of Radionuclides

(February 16, 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 Group has recently entered an equity investment agreement with ITM Isotope Technologies Munich SE (“ITM”) in Germany, whereby the Group will subscribe newly issued shares of ITM equivalent to approximately 1.31% of its enlarged share capital at the consideration of EUR 25 million. Previously, the Group has obtained the exclusive development, production and commercialization rights of 3 global innovative radionuclide-drug conjugates (the “RDC”) candidates developed by ITM in Greater China region (Mainland China, Hong Kong, Macau, Taiwan), including: (1) TOCscan® (68Ga-Edotreotide) for the diagnosis of gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”); (2) ITM-11 (n.c.a.177Lu-Edotreotide) for the treatment of GEP-NETs; and (3) ITM-41 (n.c.a.177Lu- Zoledronate) for the treatment of malignant tumors with bone metastases. The equity investment this time will further deepen the cooperation between the Group and ITM and lay a solid foundation for the Group's global deployment of the entire industrial chain of radionuclide production, research and sales.

Radionuclide diagnosis and treatment drug is one of the strategic directions of the Group in anti-tumor field which has achieved a comprehensive layout in the fields of research, production and commercialization worldwide. The Group will cooperate with its associate company Sirtex Medical Pty Ltd, its invested company Telix Pharmaceuticals Limited (ASX: TLX) and ITM 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 layout, 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.

ITM, founded in 2004 in Munich, Germany, is a radiopharmaceutical biotech company focused on the research and development, production and global supply of medical radioisotopes and radiopharmaceuticals for targeted radionuclide diagnostics and therapy of various tumors. ITM is also one of the largest medical radioisotope manufacturers in the world. ITM’s R&D team has gathered senior experts in mechanical engineering, radiopharmaceutical chemistry, nuclear physics and medicine, and has been deeply involved in the R&D and production of radiopharmaceuticals for more than 10 years. ITM has maintained close cooperation with Technical University of Munich for many years. In addition, ITM has established a GMP-compliant laboratory for the production of new generation radioisotopes and radiopharmaceuticals, equipped with clean rooms and dedicated hot cells for radiolabelling. At the same time, ITM has established a strong global radioisotope supply network by virtue of its geographical advantage of being backed by the German research neutron source Heinz Maier-Leibnitz FRM-II and Munich International Airport. ITM is one of the few leading radiopharmaceutical biotech companies in the world that integrates R&D, production and supply.

The business of ITM mainly covers three major directions: radiopharmaceuticals and medical radioisotopes, radiolabelling and quality control equipment, and GMP radiolabelling services, which can form a good complementary advantage with the development of the Group's radiopharmaceutical platform. The Group's equity investment in ITM this time will enable two parties to achieve a strong alliance in the field of radiopharmaceuticals, which will enhance the radiopharmaceutical platform of the Group in global R&D, production and supply capabilities. At the same time, the equity investment in ITM is also a successful case of in-depth cooperation between upstream and downstream enterprises in the radiopharmaceutical industry at domestic and abroad, promoting the rapid development of the domestic radiopharmaceutical industry.

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 Food and Drug Administration (“FDA”) and was recently approved by the National Medical Products Administration (“NMPA”) for commercialization in China. In terms of RDC drugs, TLX591-CDx for the diagnosis of prostate cancer was recently approved in the United States and Australia and it also obtained special authorization in Brazil to allow sales before formal approval; TLX250-CDx for the diagnosis of clear cell renal cell carcinoma has been approved by the FDA for breakthrough therapy and completed the first patient administration of Phase I clinical study in Australia; TLX101 for the treatment of glioblastoma has been granted orphan drug designation by FDA; TLX591 for the treatment of prostate cancer has been approved for Phase III clinical studies in Australia; TOCscan® for the diagnosis of neuroendocrine tumors was approved in Germany, Austria and France in 2018; ITM-11 for the treatment of GEP-NETs received orphan drug designation from the FDA and the European Medicines Agency (EMA) and is currently being evaluated compared to best standard of care treatments in ITM’s two phase III clinical trials, called COMPETE and COMPOSE; ITM-41 for the treatment of malignant tumor bone metastases is currently in Phase I clinical research. The registration of a number of RDC drugs in China is also actively being pushed forward, among which TLX591-CDx is expected to submit an Investigational New Drug (IND) application to NMPA in the first quarter of 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.

The Board of Grand Pharmaceutical Group Limited, commented, “The Group always put a high value on the R&D of innovative products and world-leading technologies in the field of radiopharmaceuticals. This equity investment in ITM this time will further consolidates the strategic cooperation between the Group and ITM. 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."