2026-10-16
On October 14, 2026, NorthStar Medical Technologies, LLC ("NorthStar"), a U.S.-based producer of radioisotopes, entered into a strategic partnership with Quarkmed.
The two parties will collaborate on the registration and filing of no-carrier-added actinium-225 (n.c.a. Ac-225) in China. Quarkmed will serve as NorthStar's Registration Agent in China, providing Investigational New Drug (IND) application support for pharmaceutical companies conducting clinical research with NorthStar's n.c.a. Ac-225.
NorthStar is the first company in the industry to achieve commercial-scale production of n.c.a. Ac-225 using electron accelerator technology.
As a contract research organization (CRO) specializing in nuclear medicine and radiopharmaceutical clinical development, Quarkmed offers integrated capabilities spanning regulatory affairs, clinical development, and study operations.
This partnership combines NorthStar's Ac-225 production capacity in the United States with Quarkmed's expertise in China's pharmaceutical regulatory landscape, further expanding the accessibility of commercial-scale n.c.a. Ac-225 in the Chinese market and supporting clinical development in targeted alpha therapy (TAT).
Radiopharmaceutical R&D is increasingly global in nature. As one of the world's major pharmaceutical markets, China is also becoming an increasingly important part of global radiopharmaceutical development strategies.
For radiopharmaceutical developers planning clinical studies in China, a reliable radioisotope supply and registration dossiers that meet local regulatory requirements are essential foundations for advancing their programs.
Through this partnership, NorthStar will be able to provide its clients with fully translated Chinese registration dossiers for n.c.a. Ac-225 that comply with electronic Common Technical Document (eCTD) requirements, supporting IND submissions to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration.
This will help streamline the filing process, reduce delays caused by cross-border communication, document translation, and time zone differences, and better align radioisotope-related registration work with clients' clinical development plans.
Frank Scholz, PhD, President and Chief Executive Officer of NorthStar
"Radiopharmaceutical development is increasingly global. By combining NorthStar's established Ac-225 production capabilities in the United States with Quarkmed's regulatory expertise and local market resources in China, we can help global radiopharmaceutical developers advance their clinical programs in China and integrate them into broader commercialization plans."
NorthStar is currently preparing for IND applications in China on behalf of multiple clients using its n.c.a. Ac-225.
To accelerate the preparation of registration dossiers, NorthStar and Quarkmed have established a collaboration mechanism to provide the necessary technical and regulatory filing documents for relevant clinical development programs.
Under the partnership, Quarkmed will focus on providing the following support:
Localization of Registration Dossiers
Providing fully translated Chinese registration dossiers for Ac-225 that comply with eCTD requirements, supporting the submission of relevant documents to the CDE.
IND Application Support
Providing IND application support for clients using NorthStar's n.c.a. Ac-225.
Regulatory Inquiry Response
Drawing on local regulatory expertise in radiopharmaceuticals to respond promptly to regulatory inquiries.
Cross-Border Communication Coordination
Reducing potential delays arising from international communication, document translation, and time zone differences.
Alignment with Clinical Development Timelines
Ensuring that regulatory filing activities remain coordinated with clients' clinical development plans.
Yuan Dawei, Chairman and General Manager of Quarkmed
"As targeted alpha therapy development continues to advance, a stable and reliable supply of no-carrier-added Ac-225 is of significant importance for Chinese sponsors conducting clinical research. At the same time, effectively connecting international radioisotope supply with local regulatory requirements is a critical link in the smooth progression of related clinical programs. Through this partnership with NorthStar, Quarkmed will leverage its expertise in nuclear medicine and radiopharmaceuticals to provide professional and efficient regulatory support in China, helping advance their clinical development programs in an orderly manner."
For pharmaceutical developers conducting clinical development with Ac-225, professional regulatory support is just as important as a reliable radioisotope supply. Another important foundation for this partnership is precisely NorthStar's continued build-out of no-carrier-added Ac-225 production and supply capacity.
In January 2026, NorthStar became the first company to achieve commercial-scale production of n.c.a. Ac-225 using electron accelerator technology. The company subsequently expanded its collaboration with Convergent Therapeutics to support late-stage clinical studies and commercialization needs.
In April of the same year, the U.S. Food and Drug Administration (FDA) accepted NorthStar's Drug Master File (DMF) for n.c.a. Ac-225, providing a regulatory pathway for pharmaceutical and biotechnology companies to use the isotope in clinical development and commercial radiopharmaceutical programs.
On the capacity front, in September 2026 NorthStar secured growth financing of up to US$185 million led by Hercules Capital to expand its Ac-225 production and radiopharmaceutical manufacturing capabilities. The company also plans to transition to a higher-capacity n.c.a. Ac-225 production line later in 2026 at its vertically integrated campus in Beloit, Wisconsin.
From commercial-scale production and regulatory documentation to ongoing capacity expansion, NorthStar is steadily enhancing its radioisotope supply capabilities for radiopharmaceutical developers worldwide. This partnership with Quarkmed adds an important element to its global supply footprint: local registration support in China.
NorthStar Medical Technologies is committed to building the supply chain infrastructure that will underpin the future of radiopharmaceuticals.
Operating from its vertically integrated campus in Beloit, Wisconsin, NorthStar produces copper-67 (Cu-67) and is the first company in the industry to achieve commercial-scale production of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron accelerator technology.
The company provides radioisotope supply and current Good Manufacturing Practice (cGMP) radiopharmaceutical development and manufacturing (CDMO) services to biotechnology and pharmaceutical partners worldwide.
By combining reliable radioisotope production capabilities with advanced manufacturing infrastructure, NorthStar aims to improve access to next-generation radiopharmaceuticals and accelerate the development and adoption of innovative cancer therapies.
Founded in 2011 and headquartered in Beijing, Quarkmed is a full-service contract research organization (CRO) providing comprehensive clinical research services. Its business covers clinical research for drugs and medical devices, data management and statistical analysis, SMO, bioanalysis, medical imaging, and international registration.
The company has deep expertise in nuclear medicine and radiopharmaceutical clinical development, with extensive experience in regulatory affairs, clinical operations, and medical imaging, alongside diversified clinical research capabilities in oncology, neuropsychiatry, and cell and gene therapy.
Guided by its service philosophy of "Growing Together, Achieving Together with Our Clients," Quarkmed continues to explore the integration of artificial intelligence and clinical research, supporting the clinical development needs of clients at home and abroad through professional expertise and technological innovation.
Address：Ping An Fortune Center, Lize Financial Business District of Beijing
