Triastek Files China’s First 3D-Printed Drug NDA: T20j (Apixaban)

Nanjing-based Triastek (三迭纪) has submitted a New Drug Application (NDA) to China’s CDE for T20j (apixaban tablets), marking the first 3D-printed drug filing in China. The milestone follows Triastek’s receipt earlier this month of the nation’s first drug manufacturing license specific to 3D printing, covering its Jiangning production site with capacity up to 300 million tablets annually.

T20j: First Commercial Candidate from Triastek’s MED Platform

• Drug: Apixaban (oral anticoagulant, treatment/prevention of venous thromboembolism).
• Technology: Manufactured with Triastek’s proprietary Melt Extrusion Deposition (MED) 3D-printing process.
• Development: Completed process validation and bioequivalence (BE) studies ahead of filing.
• Significance: Positioned to be China’s first marketed 3D-printed drug, a decade after the U.S. FDA approved Aprecia’s Spritam® (levetiracetam) in 2015 — the only 3D-printed medicine currently on the U.S. market.

Why U.S. 3D-Printed Drugs Stalled After 2015:
Despite Spritam’s approval, follow-on 3D-printed drugs in the U.S. have been limited. Key factors include:

• Narrow differentiation: Spritam primarily addressed swallowability of high-dose levetiracetam, rather than broader controlled-release or targeted delivery challenges.
• Manufacturing and scale limitations: Binder-jet printing requires layer-by-layer deposition and drying, making large-scale production slower and more costly than conventional tableting.
• Regulatory uncertainty: FDA guidance specific to 3D-printed drugs was lacking, discouraging other companies from pursuing approvals.
• Limited ecosystem adoption: Few partnerships or industry validation existed, so the technology remained largely a single-product novelty.

Triastek’s MED platform addresses many of these limitations with faster, continuous extrusion printing, flexible release profiles, and global pharma collaborations, increasing the likelihood that 3D-printed oral medicines can become a broader commercial reality.

Pipeline of 3D-Printed Medicines

Triastek is advancing a diversified portfolio of 3D-printed oral drugs, many aimed at optimized release profiles and improved patient adherence:

• T21 (tofacitinib controlled-release) – colon-targeted delivery for inflammatory bowel diseases.
• T19 (tofacitinib delayed-release) – circadian release system for rheumatoid arthritis, designed to peak at dawn when symptoms are most severe.
• T22 (riociguat gastric-retentive) – once-daily dosing to replace TID regimen.
• D23 (budesonide delayed-release) – ileum-targeted for maximal efficacy.
• T24 (ramelteon dual-release) – covers both sleep onset and maintenance via micro-structured release.

Global Collaborations

Triastek has positioned itself as a platform partner for multinational pharma:

• Eli Lilly – collaboration on GI-targeted oral delivery using MED.
• Boehringer Ingelheim – prototype and formulation development via Triastek’s Formulation by Design (3DFbD®) approach.
• Merck KGaA – strategic partnership exploring differentiated oral products.
• BioNTech – research collaboration and platform license (2024) to develop 3D-printed oral RNA therapeutics.
• Siemens – collaboration on digitalization and automation for GMP-scale production.

These deals highlight growing global interest in precision oral delivery and complex formulation challenges that conventional tableting cannot solve.

Regulatory Context

• China: With the first manufacturing license granted in September 2025, the NMPA is signaling readiness to evaluate 3D-printed medicines, bringing China in line with the U.S. FDA’s earlier precedent.
• United States: Only Aprecia’s Spritam (2015) is FDA-approved to date. Triastek has obtained multiple FDA IND clearances (e.g., gastric-retentive and circadian release candidates), though no NDA filings yet.

Outlook

If approved, T20j would make China the second regulatory market worldwide to commercialize a 3D-printed drug, positioning Triastek as both a domestic pioneer and an emerging global partner in next-generation oral delivery systems.

Reference

• CDE announcements, Triastek press releases
• FDA approval history (Aprecia Spritam®)
• Triastek partnership disclosures (Lilly, Boehringer Ingelheim, Merck KGaA, BioNTech, Siemens)