On October 15, 2026 NorthStar Medical Technologies, LLC (NorthStar), the first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron-accelerator technology, reported a strategic partnership with Quarkmed, a Beijing-based contract research organization (CRO) specializing in nuclear medicine and radiopharmaceutical clinical development, with expertise spanning pharmaceutical regulatory affairs, clinical development, and clinical trial operations. Quarkmed will serve as NorthStar’s Registration Agent in China, enabling pharmaceutical and biotechnology companies worldwide to use NorthStar’s n.c.a. Ac-225 in Investigational New Drug (IND) applications submitted to China’s Center for Drug Evaluation (CDE).
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The partnership expands global access to NorthStar’s commercial-scale n.c.a. Ac-225 supply and supports the growing development of targeted alpha therapies in one of the world’s largest pharmaceutical markets. Through Quarkmed’s local regulatory expertise, NorthStar can provide customers with fully translated, eCTD-compliant n.c.a. Ac-225 dossiers for submission alongside customer IND applications, helping streamline regulatory submissions and support efficient clinical development timelines. For sponsors, the result is simplified market entry and expanded access to NorthStar’s commercial-scale n.c.a. Ac-225 for clinical programs in China.
"The future of radiopharmaceutical development is increasingly global," said Dr. Frank Scholz, President and CEO of NorthStar. "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 clinical programs in China as part of their broader commercialization plans."
NorthStar is currently preparing to support multiple customer IND applications in China utilizing its n.c.a. Ac-225. To expedite the regulatory filing process, NorthStar and Quarkmed have established a collaborative framework that provides customers with the technical and regulatory documentation necessary to support clinical development programs.
Under the partnership, Quarkmed will serve as NorthStar’s Registration Agent, enabling:
Fully translated eCTD-compliant Ac-225 dossiers for submission to China’s CDE.
Efficient support of customer IND applications utilizing NorthStar n.c.a. Ac-225.
Rapid response to regulatory inquiries through local radiopharmaceutical regulatory expertise.
Reduced delays associated with international communication, translation, and time-zone differences.
Alignment of regulatory submissions with customer clinical development timelines.
"As targeted alpha therapy development continues to advance, a dependable supply of no-carrier-added Ac-225 is essential for sponsors in China conducting clinical research. 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 to provide professional, efficient support for China IND submissions and help sponsors advance their clinical development programs," said Dawei Yuan, Chairman and General Manager of Quarkmed.
The partnership with Quarkmed builds on several important milestones for NorthStar in 2026, as the company builds a global n.c.a. Ac-225 supply platform for radiopharmaceutical developers worldwide. In January, the company became the industry’s first producer of commercial-scale n.c.a. Ac-225 using electron-accelerator technology, which was quickly followed by an expanded partnership with Convergent Therapeutics to support late-stage clinical studies and commercial demand. In April, the U.S. Food & Drug Administration accepted NorthStar’s Drug Master File (DMF) for n.c.a. Ac-225, providing pharmaceutical and biotech companies with a validated pathway to incorporate the isotope into clinical and commercial radiopharmaceutical programs. In September, the company secured up to $185 million in growth financing, led by Hercules Capital, to scale Ac-225 production and radiopharmaceutical manufacturing. Later this year, NorthStar plans to transition to its high-capacity production line of n.c.a. Ac-225 at its integrated Beloit, Wisconsin, campus.
(Press release, NorthStar Medical Radiostopes, OCT 15, 2026, View Source [SID1234673506])