NorthStar, Quarkmed Pair to Expand No-Carrier-Added Actinium-225 Commercial-Scale Access

Editor’s Take: By ramping up to commercial scale, NorthStar can help streamline regulatory submissions, supporting more efficient clinical development timelines.

NorthStar Medical Technologies is strategically partnering with Quarkmed, a Beijing-based contract research organization (CRO). The collaboration centers on commercial-scale supply of no-carrier-added actinium-225 (n.c.a. Ac-225). NorthStar produces this using electron-accelerator technology.

In the partnership, Quarkmed will serve as NorthStar’s registration agent in China. This will permit pharmaceutical and biotechnology companies to use n.c.a. Ac-225 in Investigational New Drug (IND) applications in that country.

Quarkmed specializes in nuclear medicine and radiopharmaceutical clinical development, but its expertise also encompasses regulatory affairs and clinical trial operations.

How NorthStar Will Speed Development

By expanding global access to n.c.a. Ac-225, NorthStar can provide customers with fully translated dossiers for submission alongside IND applications. In theory, this helps streamline such regulatory submissions and support more efficient clinical development timelines.

“By combining NorthStar’s proven U.S.-based Ac-225 manufacturing capabilities with Quarkmed’s regulatory expertise and local market presence, we can help radiopharmaceutical developers worldwide advance their clinical programs in China.”

Frank Scholz, PhD, NorthStar President and CEO

For sponsors, NorthStar says, the benefit is simplified market entry. Already, according to the company, multiple customers have filed IND applications in China using its n.c.a. Ac-225.

“The future of radiopharmaceutical development is increasingly global,” NorthStar President and CEO Frank Scholz, PhD, said. Scholz touted the combination of NorthStar’s United States-based Ac-225 manufacturing capabilities and Quarkmed’s regulatory expertise and market presence in China.

“We can help radiopharmaceutical developers worldwide advance clinical programs in China as part of their broader commercialization plans,” Scholz said.

Quarkmed Says Ac-225 Essential

“A dependable supply of n.c.a. Ac-225 is essential for sponsors in China,” Quarkmed Chairman and General Manager Dawei Yuan said. “Equally important is aligning access to this isotope with local regulatory requirements. Through our collaboration with NorthStar, Quarkmed will draw on its experience in nuclear medicine and radiopharmaceutical development.”

NorthStar says it just secured up to $185 million in growth financing, in September, to scale Ac-225 production.