But we have to admit that the application of 3D printing is still a very cutting-edge and cutting-edge technology in drug research and development. At present, there are not many companies in the world that master the 3D printing technology of drugs, but in China, only Nanjing Sandianji Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Sandianji) has mastered this technology.
Recently, Triassic revealed the development path of the enterprise and the opening strategy of the 2.0 era: by opening up technical resources, establishing extensive cooperation with global pharmaceutical companies and realizing the commercialization of 3D printing drug technology.
The birth of Triassic originated from a scientific hypothesis of Professor Li Xiaoling, the founder and chief scientific officer of the company, that is, 3D printing technology can freely design and flexibly manufacture pharmaceutical preparations, thus breaking through the limitations of existing pharmaceutical technology in design space.
In the view of Dr. Cheng Senping, the founder and CEO of Sandie, the manufacturing of materials such as preparation technology is still the product of the industrial 2.0 era, while the 3D printing technology is the product of the industrial 4.0 era, and it is a manufacturing method that turns the blueprint on the computer into a physical object, so it has digital properties.
Founded in July, 2065438+2005, Sandie established the vision of "becoming an intelligent pharmaceutical enterprise with global influence" from the very beginning, and planned its development path in three stages:
From 20 15 to 20 19, in the Triassic 1.0 era, the technology of 3D printing drug platform was developed with intellectual property as the strategy.
From 2020 to around 2025, in the Triassic 2.0 era, we will establish extensive business cooperation with global pharmaceutical companies and give full play to the value of emerging technologies.
From 2026, Triassic will enter the 3.0 era and become an important provider of global intelligent pharmaceutical technology.
Cheng Senping summarized the key words of the three development stages of Triassic as technology, products and commerce, and globalization. At present, the Triassic is in the 2.0 era. For the future development, Cheng Senping said that while continuing technological innovation, Triassic will serve the global pharmaceutical companies with the power of platform technology and promote the digitalization and intelligence of the pharmaceutical industry.
Along the principle of 3D printing, hot melt extrusion deposition technology (MED) was developed and industrialized in Triassic. Triassic MED 3D printing pharmaceutical production technology has changed the traditional pharmaceutical technology, redefined the underlying logic, process flow and production mode of preparation technology based on Industry 4.0, and realized continuous, intelligent and real-time quality control of pharmaceutical production.
Technically, the Triassic has carried out more than ten iterations on 3D printing drug equipment, and studied the release mechanism of 3D printing drugs, and explored the international registration and declaration channels and commercialization paths of products. In terms of patents, Triassic has 13 1 patent applications in the world, accounting for more than 20% of the global 3D printing drug field; In terms of production capacity, Triassic will build a continuous production line of 3D printed drugs with an annual output of 50 million tablets by the end of this year.
At present, the Triassic has realized the drug research and development of the 3D printing drug production technology route, and the company has submitted IND or Pre-IND applications for three products to the US Food and Drug Administration (FDA). In the world, this number is only four, and Triassic has occupied three of them.
Among them, the first Triassic product T 19 was approved for clinical trial (IND) on 202 1 10, which is also the second 3D printed pharmaceutical product in the world to submit IND to the US FDA for the treatment of rheumatoid arthritis. At the same time, the product has been pre-declared to the State Administration of Pharmaceutical Products of China in June this year. The company's second product T20 received a positive response from FDA Pre-IND in March this year. The third product T2 1 submitted a Pre-IND meeting application to the FDA in September this year.
In addition, Sandie R&D is not limited to self-developed products, but positioned as a technology platform company, adopting the strategy of dual-core driving of equipment and drugs to accelerate the research and development of emerging technologies and product applications. It is reported that it has reached global development and commercial cooperation with three multinational pharmaceutical giants and three China pharmaceutical companies.
Cheng Senping said that the Triassic will implement an open strategy, establish extensive cooperation with global pharmaceutical companies through opening up technical resources, and quickly realize the commercialization of emerging technologies. She said: "We hope to cooperate with multinational pharmaceutical companies to develop new drugs, solve the problem of drug formation of new molecules, or extend the life cycle of existing products. We hope to cooperate with China Pharmaceutical Company to develop global products and help them enter the international market by developing pharmaceutical products with technical barriers and strong patent protection. "