Introduction: The use of 3D printingtechnology in the pharmaceutical field can enable the manufacture of drug formulations with complex internal three-dimensional structures, bringing unlimited possibilities for the development and production of certain drug products.
On 1 July 2022, Nanjing Triadic Pharmaceutical Technology Co., Ltd ("Triadic") announced that the company's first 3D printed drug product, T19, has been approved for drug clinical trials (IND) by the National Medicines and Drug Administration (NMPA). The product is registered in China as a Class 2.2 Modified New Drug and is the first known 3D printed drug product to receive IND approval in China.
△Image source: State Drug Administration Drug Review Centre website
T19 is a 3D printed drug with global intellectual property designed and developed by Triadic independently. The product is designed to address the circadian rhythm of rheumatoid arthritis symptoms based on the principles of chronotherapy. When patients take T19 at bedtime, the drug concentration in the blood peaks in the morning when symptoms of the disease, such as pain, joint stiffness and dysfunction, are most severe, and maintains its daytime blood concentration, thus achieving optimal drug therapeutic effects.
Rheumatoid arthritis has a huge clinical and market demand in major market countries such as the United States and China, and the China Rheumatoid Arthritis Development Report 2020 shows that there are currently about 5 million rheumatoid arthritis patients in China, with an average age of onset of only 45 years. Forecasts indicate that the global market for rheumatoid arthritis is expected to reach US$30.7 billion by 2025 (CAGR 4.5%).
Rheumatoid arthritis (RA) is a common chronic disease and according to key opinion leaders (KOL) interviews in the US and China, morning symptoms remain a major problem for patients with rheumatoid arthritis and T19's unique chronotherapy benefits will provide better clinical options for patients. Previously, T19 was filed for registration with the US FDA via the 505(b)(2) pathway to receive an IND in 2021, and is the second known publicly available 3D printed drug product in the world to be filed for registration with the US FDA. The product will next undergo clinical studies in the US and China, respectively, and submit marketing applications (NDAs) to the FDA and NMPA.
Dr. Seng Seng Ping, Founder and CEO of Triadic, said: "The IND approval of the T19 product in China is a milestone for the international registration of T19. During the review and communication process, we felt the encouragement and support from CDE for the emerging pharmaceutical technology. Triadic's 3D printing-based continuous formulation production technology responds to the direction of the national 14th Five-Year Plan for the development of the pharmaceutical industry to enhance high-end formulation production technology and promote systematic upgrading of pharmaceutical manufacturing capabilities. In the future, we will use advanced pharmaceutical technology to bring better clinical value and higher quality drugs to Chinese patients.
We also hope that Triadic's 3D printed drug products will complete clinical trials as soon as possible and be available for sale soon.
