China's First 3D-Printed Drug, Triastek's T19, Receives NMPA IND Approval

Recently, Nanjing Triastek Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Triastek”) announced that its first 3D-printed drug product, T19, has received approval for an Investigational New Drug (IND) application from the National Medical Products Administration (NMPA). The product is registered and filed in China as a Class 2.2 improved new drug and is the first known 3D-printed drug product to receive IND approval in China.

 Image source: Official website of the Center for Drug Evaluation, National Medical Products Administration

T19 is a 3D-printed drug independently developed by Triastek with global intellectual property rights. Designed based on the principles of chronotherapy, this product targets the circadian rhythm of rheumatoid arthritis symptoms. Patients take T19 before bedtime, allowing plasma drug concentrations to peak in the morning when disease symptoms such as pain, joint stiffness, and functional impairment are most severe, while maintaining therapeutic levels throughout the day, thereby achieving optimal pharmacotherapeutic efficacy.

Rheumatoid arthritis presents substantial clinical and market demand in major markets such as the United States and China. The global market size is projected to reach $30.7 billion by 2025, with a compound annual growth rate (CAGR) of 4.5%. According to interviews with key opinion leaders (KOLs) in clinical practice in both China and the United States, morning symptoms remain a primary concern for patients with rheumatoid arthritis. T19’s unique chronotherapeutic advantages will offer patients improved clinical treatment options.

Previously, T19 was submitted for registration with the U.S. FDA via the 505(b)(2) pathway and obtained Investigational New Drug (IND) approval in 2021, making it the second publicly known 3D-printed drug product to be registered with the U.S. FDA globally. The product will subsequently conduct clinical trials in the United States and China, respectively, and submit New Drug Applications (NDAs) to both the FDA and the National Medical Products Administration (NMPA).

Dr. Senping Cheng, Founder and CEO of 3DiteriumIndicates:The approval of the Investigational New Drug (IND) application for T19 in China marks a milestone in its international registration. Throughout the review and communication process, we have felt the Center for Drug Evaluation’s (CDE) encouragement and support for emerging pharmaceutical technologies. Triastek’s continuous manufacturing technology for drug formulations, based on 3D printing, aligns with the guidance of China’s “14th Five-Year Plan” for Pharmaceutical Industry Development, which aims to enhance advanced formulation production technologies and drive systemic upgrades in pharmaceutical manufacturing capabilities. In the future, we will leverage advanced pharmaceutical technologies to deliver drugs with superior clinical value and higher product quality to patients in China.