Triastek Secures China's First 3D-Printed Drug Manufacturing License, Marking a New Era of Digital Innovation in Chinese Pharma | DaoTong Family
In September 2025, **Triastek, a Dalton Venture portfolio company, received the nation's first Pharmaceutical Manufacturing License for 3D-printed drug production issued by the Jiangsu Provincial Medical Products Administration**. This marks the first time that 3D printing pharmaceutical technology in China has achieved compliant, regulated manufacturing. It represents a critical step forward for Triastek in drug R&D and industrialization, as well as another milestone for Dalton Venture's investments in pharmaceutical innovation.
Background
In September 2025, Triastek, a Dalton Venture portfolio company, received China's first-ever Drug Manufacturing License for 3D-printed pharmaceuticals from the Jiangsu Provincial Medical Products Administration. This marks the first time 3D-printed drug manufacturing technology has achieved regulatory-compliant production in China — a critical milestone in Triastek's drug development and commercialization journey, and another landmark achievement for Dalton Venture's investments in pharmaceutical innovation.
Global-Scale Production Capacity + A Novel Technical Pathway
The license was issued for the world's largest commercial-scale 3D-printed digital drug production facility. Located in the Jiangning District Life Science Accelerator Zone in Nanjing, the site encompasses a MED® (Melt Extrusion Deposition) production center, a quality control center, and a warehousing center, with an annual production capacity of up to 300 million 3D-printed tablets.
Compared with traditional pharmaceutical manufacturing, Triastek's MED® 3D printing technology demonstrates significant advantages across multiple dimensions, including complex tablet structural design, precise drug delivery, digitalization and intelligentization of formulation development, and full-process quality control — providing an entirely new pathway for high-quality development and technological upgrading in the pharmaceutical industry.
Government-Industry Collaboration Accelerating Innovation Translation
Throughout Triastek's product development, GMP system establishment, and quality system construction, the Jiangsu Provincial Medical Products Administration actively implemented its service mechanism of "early engagement, full-process participation, and integrated R&D-review coordination." It established a dedicated task force led by the bureau's top leadership, organized multiple cross-departmental on-site guidance sessions, and provided cutting-edge policy counseling and technical guidance. This tangible support helped Triastek overcome critical challenges in product development, manufacturing compliance, and regulatory submission, creating an excellent environment for innovation and growth.
From license application submission to on-site inspection and guidance by provincial expert teams, through to formal license issuance, the entire process was efficient and smooth. Provincial experts maintained close communication with the Triastek team, offering numerous valuable recommendations, while the company comprehensively elevated its quality management and compliance system capabilities throughout this process.
First Product Nearing Market Launch
With this manufacturing license in hand, a 3D-printed drug in Triastek's portfolio — apixaban tablets (T20j) — now meets the conditions for market registration. The product has completed pharmaceutical research and clinical trials, and will submit a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration in September, marking a new chapter in the commercialization of 3D-printed drugs in China.
Going forward, Triastek will continue to leverage the policy support and technical guidance of the Jiangsu Provincial Medical Products Administration to jointly advance the market launch of China's first 3D-printed pharmaceutical product, making greater contributions to innovation and transformation in China's pharmaceutical industry.
ID: daltonventure
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