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ITM And Grand Pharma Enter Into A Commercialization Agreement For Targeted Radiopharmaceuticals In The Greater China Area

Grand Pharma has licensed the development, manufacturing and commercialization rights of ITM’s Targeted Radionuclide Therapeutic candidates ITM-11 (n.c.a 177Lu-edotreotide) and ITM-41 (n.c.a 177Lu-zoledronate) as well as diagnostic TOCscan® (68Ga-edotreotide) for the treatment and diagnosis of cancer patients in Greater China
ITM to receive a significant upfront payment as well as potential regulatory and commercial milestone payments totaling up to approximately EUR 520 M in addition to tiered royalties

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Grand Pharmaceutical Group Limited (GP) a diversified global pharmaceutical company listed in Hong Kong, today announced that they have entered into an exclusive licensing agreement for GP to develop, manufacture and commercialize ITM’s oncological radiopharmaceutical candidates, ITM-11  and ITM-41  as well as the diagnostic TOCscan (68Ga-edotreotide) in the territory of mainland China, Hong Kong, Macau and Taiwan.

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Under the terms of the agreement, ITM grants GP an exclusive license for the named products in the licensed territory and will support the supply of the pharmaceutical materials needed to conduct clinical and commercial activities. GP will be responsible for clinical development, regulatory activities and commercialization of these products in the licensed geographies. ITM is eligible for a significant upfront payment as well as potential aggregate regulatory and commercial milestone payments totalling up to approximately EUR 520 million in addition to tiered royalties.

“In line with our isotope production collaboration with CIRC and the formation of our Shanghai subsidiary (WFOE) in 2021, ITM continues to strengthen its global footprint in Asian regions. This agreement with GP creates a strong partnership that supports the development and future commercial launch of our targeted radiopharmaceutical products with a recognized leader in Asia,” commented Steffen Schuster, Chief Executive Officer of ITM. “We look forward to working with GP to develop and provide our radiopharmaceuticals in a region with a growing patient population in need of precision oncology treatments.”

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“We value our strategic partnership with ITM as we focus on bringing improved precision oncology treatments to Greater China,” said Frank Zhou, Chief Executive Officer of GP. “By combining our resources, expertise and patient-centric approach we are confident in our ability to develop, distribute and commercialize innovative and high quality radiopharmaceutical products.”

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ITM-11 (n.c.a. 177Lu-edotreotide) is ITM’s most advanced Targeted Radionuclide Therapy being developed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is currently undergoing two phase III clinical trials, COMPETE for patients with grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. ITM-11 has already demonstrated a favorable safety and efficacy profile in phase II clinical evaluation in GEP-NET patients. ITM-41 (n.c.a. 177Lu-zoledronate) is in preclinical development for in the treatment of osteosarcoma and bone metastases. TOCscan® (68Ga-edotreotide) is ITM’s radiopharmaceutical for the diagnosis and staging of neuroendocrine tumors (NETs).

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