As the momentum continues to pick up at NorthStar Medical Technologies, the radioisotope producer is strengthening ties in China, in a move that helps put its actinium-225 supplies on the map for local radiopharmaceutical filings.
NorthStar on Thursday said it had linked up with Beijing-based contract research organization (Quarkmed)—also focused on nuclear medicine and radiopharmaceuticals—under a strategic partnership that will see Quarkmed serve as NorthStar’s registration agent in China. In turn, biopharmas in China and abroad will be able to use NorthStar’s Ac-225 in investigational new drug applications submitted there, according to an Oct. 15 release.
Ac-225 has become an increasingly popular isotope for next-generation radiopharmaceutical therapies, and NorthStar kicked off the year by announcing that it had successfully carried out commercial-scale production of Ac-225 on its electron accelerator-based technology at its campus in Beloit, Wisconsin.
With the Quarkmed tie up, NorthStar will offer up dossiers and other documentation on its isotope to help streamline regulatory submissions, with the overall goal that the collaboration will result in “simplified market entry and expanded access to NorthStar’s commercial-scale n.c.a. Ac-225 for clinical programs in China,” the company said Thursday.
The company added that it’s presently preparing to support “multiple” customers’ new drug applications in China that will leverage its Ac-225 supplies.
“The future of radiopharmaceutical development is increasingly global,” said Frank Scholz, Ph.D., president and CEO of NorthStar, in a statement.
“By combining NorthStar’s proven U.S.-based Ac-225 manufacturing capabilities with Quarkmed’s regulatory expertise and local market presence,” he continued, “we can help radiopharmaceutical developers worldwide advance clinical programs in China as part of their broader commercialization plans.”
NorthStar has been on a steady rise since the announcement of its commercial-scale manufacturing milestone in January, which intersected with news that it had expanded its arrangement with Convergent Therapeutics to chip in Ac-225 for late-stage studies and potential commercial supplies of the biotech’s experimental radiopharmaceutical treatment for metastatic castration-resistant prostate cancer.
More recently, the company in late September secured an up to $185 million growth capital facility from Hercules Capital, with $100 million coming upfront to accelerate investments in radioisotope production and clinical manufacturing.
NorthStar is aiming to fill gaps in the radiopharmaceutical supply chain that have blunted the modality’s trajectory in the past.
Part of what the company sees as its secret sauce is that it is “integrating the supply chain” through the co-location of actinium production and CDMO services on a single campus in Beloit, CEO Scholz said in a recent interview.
Given the half-life of the radioactive materials NorthStar is working with, the shorter the production process is, the better the potential yield. And, if you have those services on the same campus, as NorthStar does, “you are the fastest relative to everybody else,” Scholz added at the time.