Triastek Opens a New Chapter for Digital Formulation Development and Intelligent Pharmaceutical Manufacturing

Triastek开启了数字化配方开发和智能制药制造的新篇章

Triastek, Inc. ("Triastek"), a pharmaceutical company specializing in 3D printing of drug products, announced today that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) 505(b)(2) application for its first 3D printed drug product – T19, indicated for the treatment of rheumatoid arthritis (RA). Developed in-house, Triastek has global intellectual property rights to the T19 3D printed formulation.

Triastek, Inc .(“Triastek”),一家制药公司专门从事药物产品的3 d打印,今天宣布,美国食品和药物管理局(FDA)批准了其试验性新药(印第安纳州)505 (b)(2)首次申请3 d印刷药品——T19表示治疗类风湿性关节炎(RA)。Triastek自主研发，拥有T19 3D打印配方的全球知识产权。

The novel design made possible by 3D printing allows T19 to function as a chronotherapeutic drug delivery system, targeting the circadian nature of RA symptoms. Patients take T19 at bedtime with the tablet releasing drug in a delayed manner such that the blood concentration peaks in the early morning hours when the symptoms of pain, joint stiffness and dysfunction are most acute. T19 utilizes Melt Extrusion Deposition (MEDTM) 3D printing technology to achieve three-dimensional tablet structures that allow precise control of drug release to achieve the desired target PK in the human body, with the goal of addressing these unmet needs of RA patients.

3D打印的新设计使T19成为一种计时治疗给药系统，针对RA症状的昼夜节律特性。患者延迟在睡前服用T19缓释片，清晨血药浓度达到高峰，此时疼痛、关节僵硬、功能障碍症状最严重。T19利用熔融挤压沉积(MEDTM) 3D打印技术实现三维片剂结构，允许精确控制药物释放，以实现人体所需的靶PK，以解决RA患者这些未满足的需求。

It is predicted that by 2025, the global RA market will reach $30.7 billion (CAGR 4.5%), with T19's unique chronotherapeutic delivery system providing patients with a much-needed therapeutic option. Informa, a pharmaceutical market intelligence consulting company, suggests that T19 can capture substantial portion of RA market in China and the U.S after launch.

据预测，到2025年，全球RA市场将达到207亿美元(复合年增长率4.5%)，T19独特的chronotherapeutic delivery系统将为患者提供急需的治疗选择。一家医药市场情报咨询公司Informa表示，T19在上市后可以在中国和美国占领大量的RA市场。

Triastek plans to apply for IND approval in China later this year, followed by applications in Japan and Europe. The New Drug Application (NDA) of T19 is expected to be filed to the U.S. FDA in 2023.

Triastek计划今年晚些时候在中国申请新药研发批准，随后在日本和欧洲申请。T19的新药申请(NDA)预计将于2023年提交给美国FDA。

Following T19, Triastek has developed 505(b)(2) product portfolio to meet specific clinical needs and improve the outcomes of drug therapy using MEDTM 3D printing technology.

继T19之后，Triastek开发了505(b)(2)产品组合，以满足特定的临床需求，并使用MEDTM 3D打印技术改善药物治疗的结果。

Background on MEDTM 3D printing technology

MEDTM 3D打印技术背景

The MEDTM 3D printing technology platform encompasses digital pharmaceutical dosage form design, an efficient product development approach and automated intelligent manufacturing. Tablets can be constructed to have sophisticated shapes and internal geometric structures that serve to modulate the onset time, kinetics, duration, and mode of drug release with great predictability and reproducibility. This customizable release kinetics can help to enhance therapeutic effects, lower side effects, improve compliance, and efficiently develop pharmaceutical products in different stages.

MEDTM 3D打印技术平台包括数字化药物剂型设计、高效的产品开发方法和自动化智能制造。片剂可以被构造成具有复杂的形状和内部几何结构，用以调节药物释放的起始时间、动力学、持续时间和模式，具有很大的可预测性和再现性。这种可定制的释放动力学有助于提高治疗效果，降低副作用，提高依从性，并在不同阶段高效开发药品。

Triastek has also developed a novel pharmaceutical product development method, 3D printing formulation by design (3DFbD®), to circumvent the trial and error or experience oriented traditional formulation development process. This methodology greatly improves the efficiency and success rate of drug product development, thereby reducing development time and costs. Moreover, integration of real-time Process Analytical Technology (PAT) in the continuous MEDTM 3D printing manufacturing system enables continuous monitoring of the manufacturing process to assure production quality, reduce manufacturing cost, and to provide convenience for regulatory monitoring.

Triastek还开发了一种新的制药产品开发方法，3D打印配方设计(3DFbD®)，以规避以试验和错误或经验为导向的传统配方开发过程。该方法大大提高了药品开发的效率和成功率，从而减少了开发时间和成本。同时，将实时过程分析技术(PAT)集成到MEDTM 3D打印连续制造系统中，可以对制造过程进行连续监控，以保证生产质量，降低制造成本，并为监管监控提供便利。

In April 2020, Triastek’s MEDTM 3D printing was accepted into the FDA Emerging Technology Program (ETP). FDA recognized MEDTM 3D printing based on the following features: (a) the proposed use of a MEDTM based 3D technology to manufacture modified release solid oral dosage form, and (b) a fully automated process using PAT and feedback controls.

2020年4月，Triastek公司的MEDTM 3D打印技术被FDA新兴技术项目(ETP)接受。FDA认可MEDTM 3D打印是基于以下特点:(a)提议使用基于MEDTM的3D技术来生产改良的固体口服剂型，(b)使用PAT和反馈控制的全自动过程。

Dr. Senping Cheng, co-founder and CEO of Triastek, said, "Triastek is committed to improving the efficiency of formulation development, enhancing the effects of drug products, and ensuring the quality of drug delivered to patients by using 3D printing technology platform. The FDA IND clearance of T19 is an important milestone in the development and application of MEDTM 3D printing technology."

Triastek联合创始人兼首席执行官程森平博士表示:“Triastek致力于通过3D打印技术平台，提高制剂开发效率，提升药品效果，确保药物传递给患者的质量。FDA对T19的批准是MEDTM 3D打印技术开发和应用的一个重要里程碑。”

Dr. Xiaoling Li, co-founder and CSO of Triastek, said, "We believe that the MEDTM 3D printing technology will be the enabler for digital pharmaceutical product development and intelligent drug manufacturing. Triastek will work with any interested parties to take advantage of this platform technology for developing pharmaceutical products with better clinical value and higher product quality."

Triastek联合创始人兼首席技术官李晓玲博士表示:“我们相信，MEDTM 3D打印技术将成为数字化医药产品开发和智能药物制造的推手。Triastek将与任何感兴趣的各方合作，利用这一平台技术开发具有更好临床价值和更高产品质量的制药产品。”

About Triastek, Inc.

关于Triastek公司。

Triastek is an international pharmaceutical company founded in July 2015 by Dr. Senping Cheng, who has entrepreneurial experience both in China and the United States, and Dr. Xiaoling Li, an American pharmaceutical scientist and educator. It is committed to building a novel 3D printing pharmaceutical technology platform for dosage form design, product development, and intelligent manufacturing. In-house product development and co-development with partners are two main business models; in terms of co-development, Triastek has reached a number of agreements with top multinational and Chinese pharmaceutical companies. Triastek’s mission is to be a global leader in the field of 3D printing pharmaceuticals and establish a new era of intelligent pharmaceutical manufacturing.

Triastek是一家由在中国和美国都有创业经历的程森平博士和美国制药科学家、教育家李晓玲博士于2015年7月创办的国际制药公司。致力于打造新型3D打印制药技术平台，用于剂型设计、产品开发和智能制造。内部产品开发和与合作伙伴共同开发是两种主要的商业模式;在合作开发方面，Triastek已经与一些顶级跨国公司和中国制药公司达成了多项协议。Triastek的使命是成为全球3D打印制药领域的领导者，开创智能制药制造的新时代。