· Triastek and Siemens signed a deepening strategic cooperation agreement to accelerate the digitalization of the pharmaceutical industry

· China's first 3D printed drug product entering the clinical stage development made its debut at the CIIE

· Triastek is implementing the open strategy of the 2.0 era and works with global partners to build a complete ecosystem of pharmaceutical materials, digital equipment, new dosage form research, and new drug product development and commercialization

From technological innovation to digitalization of the pharmaceutical industry, "Chinese innovation" in the pharmaceutical industry is going global. On November 6, at the 6th China International Import Expo (or "CIIE"), Triastek as a partner in digitalization, signed a deepening strategic cooperation agreement with Siemens. Concurrently, a 3D printed drug development prototype was also unveiled at Boehringer Ingelheim’s booth, showcasing the application of emerging technologies in the development of pharmaceutical dosage forms.

As the world's first national-level expo dedicated to imports, the CIIE underscores China's unwavering dedication to promoting high-level international cooperation and has become an excellent platform for foreign enterprises to tap into China's big market, showcasing new products in areas of high-end equipment manufacturing, environmental protection, and biotechnology. This year's CIIE was themed " New era, shared future, " with more than 3,400 companies from 154 countries and regions participating, and more than 400 new products, new technologies, and new services displayed. This is the first time Triastek has participated at the CIIE, during which, the company showcased their innovative practices of 3D printing technology in the pharmaceutical industry to other companies around the world.

Triastek Signed a Deepening Strategic Cooperation Agreement with Siemens to Promote the Digitalization of the Pharmaceutical Industry

On November 6, Triastek and Siemens signed a deepening strategic cooperation agreement while attending CIIE. This is the second time that the two companies have partnered with each other after signing a strategic cooperation agreement in March 2022. The two companies will continue to focus on the goal of "digitalization of the pharmaceutical industry" to jointly develop world-leading digital pharmaceutical technology and production solutions and promote the digital transformation of global pharmaceutical companies.

In March 2022, Triastek and Siemens reached a strategic cooperation agreement. Triastek is utilizing its proprietary Melt Extrusion Deposition (MED®) 3D printing process for drug research and development and the development of production equipment. Siemens provides it with world-leading technical solutions and high-stability products in the fields of automation and digitalization.

Triastek and Siemens signed an agreement to deepen strategic cooperation

In the past year, both companies have leveraged their respective technical advantages to apply digital technology to the digitization of drug R&D and production, continuous pharmaceutical manufacturing and other process improvements to facilitate the digitalization of drug R&D and production, promoting real-time detection and release of drug production, as well as construction and operation of digital pharmaceutical factories. Industrial digitalization is reshaping the landscape of pharmaceutical innovation. Continuous manufacturing and digitalization of the pharmaceutical industry is being promoted by drug regulatory authorities in various countries, including the US FDA, European Medicines Agency and China's National Medical Products Administration (NMPA). Triastek is actively responding to these requirements of regulatory authorities by promoting the continuous manufacturing, digitization, and intelligent manufacturing of pharmaceutical technology.

In the future, Triastek and Siemens will conduct technical exploration and in-depth cooperation in digital pharmaceutical centers, smart laboratories, AI drug research and development and smart production, striving to provide global pharmaceutical companies with efficient digital drug development and production solutions to accelerate the digital strategic transformation of global pharmaceutical companies.

China's First 3D Printed Drug Product Entering the Clinical Stage Debuts at the CIIE

At this year's CIIE, Triastek presented China's first 3D printed drug product that has entered clinical stage development. In July 2022, Triastek's 3D printed drug product T19 was approved for drug clinical trials (IND) by the NMPA. This is the first 3D printed drug to obtain IND approval in China. The drug was also approved in 2021 and obtained IND approval from the FDA in the United States.

Triastek 3D printed pharmaceutical product T19

Different from ordinary solid preparations, these tablets have a completely different internal structure, which is printed and deposited layer by layer to form a final pharmaceutical preparation product with an internal "three-dimensional structure". T19 is designed to target the circadian rhythm of rheumatoid arthritis symptoms based on the principles of chronotherapy. Symptoms of joint stiffness in rheumatoid arthritis are often worse in the morning, and T19 is designed to allow patients to take the drug before bed, with drug concentrations in the blood peaking in the morning to achieve better symptom relief.

Dr. Senping Cheng, founder and CEO of Triastek, introduced at the CIIE, "The T19 product has obtained IND clearance from regulatory agencies in China and the United States respectively. This is a milestone for 3D printed pharmaceutical products and an innovative technological breakthrough for the domestic pharmaceutical industry. Currently, the product is undergoing clinical research in the United States and China, and a New Drug Application (NDA) will be submitted to the FDA and NMPA in the future."

In April 2020, Triastek's MED 3D printing process and the first product T19 were accepted by the U.S. FDA's Emerging Technology Program (ETP). The Emerging Technology Team at FDA determined that the MED process is a new production method for controlled-release oral solid preparations. This process innovation of fully automatic integrated Process Analysis Technique (PAT) and feedback control was particularly highlighted. T19 is the first known product from a Chinese pharmaceutical company to be included in the U.S. FDA's Emerging Technology Program (ETP). It is also the first domestic drug product to be registered and declared through 3D printing continuous manufacturing.

Currently, Triastek has obtained 4 IND clearances (3 in the US and 1 in China) for 3 distinct products. With a number of self-developed products entering the clinic, Triastek has verified its 3D printing drug technology platform capabilities. Based on Triastek's two business models of "product partnership" and "technology platform partnership", more and more leading companies are working with Triastek to participate in this new global wave of drug 3D printing.

From Innovation to the Digitization of the Pharmaceutical industry,

Triastek Opens up Technological Resources to Build an Emerging Industry Ecosystem

"Opening up" is the basic model connecting China and the world. The CIIE has witnessed and promoted China's high-level opening-up process. Dr. Senping Cheng said: “The CIIE will allow the world to share open resources, which is consistent with the 2.0 era opening strategy released by Triastek in 2021. We hope to establish extensive collaborations with global pharmaceutical companies including upstream and downstream partners through open technical resources to realize the commercialization of 3D printing drug technology."

3D printed drug development prototype unveiled at Boehringer Ingelheim booth

From 2015 to 2019, in the Triastek 1.0 era, the company adopted an "intellectual property driven" philosophy as its strategy and completed the development of 3D printing drug platform technology and the intellectual property layout of innovative technologies. From 2020 to 2025, in the Triastek 2.0 era, the company will fully leverage the value of emerging technologies through extensive collaborations. Starting in 2026, Triastek will enter the 3.0 era and hopes to become an important provider of global smart pharmaceutical technology.

In the 2.0 era, Triastek has established collaborations with several multinational pharmaceutical companies, pharmaceutical excipient companies and digital technology providers to jointly promote the application of 3D printing technology in the field of digital pharmaceuticals. Dr. Senping Cheng said: "Though pharmaceutical 3D printing has been available for nearly 30 years, it is entering a new era forming the next high-potential emerging industry. We hope to join hands with more global pharmaceutical companies and upstream and downstream partners to jointly build a complete ecosystem for pharmaceutical materials, digital equipment, new dosage form research, and the development and commercialization of new drug products.”