But we have to recognize that 3D printing is still a very cutting-edge technology for drug development, and at the moment, there are not many companies that have mastered the technology of 3D printing for drugs in the world, and in China, there is only one company that has mastered this technology, Nanjing Sanyiqi Pharmaceuticals Science and Technology Company Limited (hereinafter referred to as: Sanyiqi).
Recently, Sundial has disclosed its development path and 2.0 era open strategy, which is to realize the commercialization of 3D printing drug technology by opening up its technical resources and establishing extensive cooperation with global pharmaceutical companies.
The birth of Sundial was born from a scientific hypothesis of the company's founder and Chief Scientific Officer, Prof. Xiaoling Li Ph.D., that 3D printing technology can freely design and flexibly manufacture drug formulations, thus breaking through the limitations of the existing pharmaceutical technology in terms of design space.
According to Dr. Seng Senping, founder and CEO of San Diego, current formulation technology iso-materials manufacturing is still a product of the Industry 2.0 era, whereas 3D printing technology is a product of the Industry 4.0 era, a manufacturing method that turns blueprints on computers into physical objects, and therefore has digital attributes.
Founded in July 2015, San Diego has established the vision of "becoming a smart pharmaceutical company with global influence" since the beginning of its foundation, and has planned a three-stage development path:
From 2015 to 2019, San Diego's 1.0 era, with intellectual property rights driving its strategy, has completed the 3D printing drug platform. that completes the development of 3D printed drug platform technology.
From 2020 to around 2025, the Tridium 2.0 era, with extensive commercial collaborations with global pharmaceutical companies to fully utilize the value of emerging technologies.
Starting from 2026, Tricore will step into the 3.0 era and become a key provider of smart pharmaceutical technologies globally.
Cheng Senping summarized the keywords of the three development stages of Sundial as technology, product and business, and globalization. Currently, Sundial is in the 2.0 era. For the future development, Cheng Senping said that while continuing to carry out technological innovation, Sundial will use the power of platform technology to serve global pharmaceutical enterprises and promote the digitalization and intelligence of the preparation industry.
Along the principle of 3D printing, Sundial has carried out the development of hot melt extrusion deposition (MED) technology and achieved industrialization. SUNRISE's MED 3D printing drug production technology has transformed the traditional pharmaceutical process, redefined the underlying logic, process flow and production mode of formulation technology based on Industry 4.0, and realized continuous, intelligent and real-time quality control of drug production.
In terms of technology, Sundial has iterated 3D printing drug devices for more than ten times, and at the same time researched the release mechanism of 3D printing drugs, explored the pathway of product international registration and commercialization. In terms of patents, Sundial has 131 patent applications worldwide, accounting for more than 20% of the world's 3D printed drug field; in terms of production capacity, by the end of this year, Sundial will build a continuous production line with an adult production capacity of 50 million tablets of 3D printed drugs.
At present, Sundial has already realized the drug development of 3D printing drug production technology route, the company has submitted 3 products to the U.S. Food and Drug Administration (FDA) IND or Pre-IND application, and in the world, this number is only 4, Sundial occupies 3 of them.
The first of these products, T19, was approved for clinical trials (IND) in January 2021, making it the second 3D-printed drug product in the world to have an IND filed with the FDA for the treatment of rheumatoid arthritis. The product also made a Pre-IND filing with the State Drug Administration of China in June this year. The company's second product, T20, received a positive Pre-IND response from the FDA in March of this year. The third product, T21, was submitted to the FDA for Pre-IND meeting in September this year.
In addition, San Diegui's R&D is not only on self-developed products, but also positioned itself as a technology platform company, adopting the strategy of dual-core driving of devices and drugs to accelerate the development of emerging technologies and product applications, and it is reported that it has already reached a global development and commercial cooperation with 3 multinational pharma giants and 3 Chinese pharmaceutical companies in the global development of 3D-printed drugs.
Cheng Morihei said that San Diegui will carry out its open strategy to rapidly commercialize emerging technologies by opening up its technological resources and establishing extensive collaborations with global pharmaceutical companies. We want to work with multinational drug companies*** to develop new drugs, solve the problem of drugability of new molecules, or extend the life cycle of existing products," she said. We want to collaborate with Chinese drug companies to develop global products and help them enter the international market by developing drug products with technical barriers and strong patent protection."