Meanwhile, Triastek’s first drug, an anticoagulant called Apixaban (T20j), has passed clinical trials in China and is now being submitted for market approval. The company is also advancing its gastric retention drug (T20G), which recently received Investigational New Drug (IND) clearance from both the U.S. FDA and Chinese regulators.
Deng Feihuang, Triastek’s vice-president of technology, said the company is already building a second line for hormone drugs, with plans to expand its production base by year’s end.
Beyond that, Triastek already has over ten other drug candidates in phase I or II trials, spanning both small and large molecules.
The Bigger Picture
Triastek’s factory is designed to be fully digital and traceable, so each tablet’s manufacture can be tracked from raw material through finish. More importantly, because development cycles are compressed, new medicines could move from lab to production in months instead of years.
But there are still a few challenges. Regulatory approval is a major hurdle, and designing and manufacturing 3D printed drugs pushes existing rules. Also, scale and consistency are important in pharmaceuticals; tiny errors in printing could cause big problems. What’s more, quality, reproducibility, and oversight will be under intense scrutiny.
There is no doubt that investing in this kind of facility is capital-intensive, and many patients and regulators may be careful about accepting a medicine that is made in this way.
Still, for thousands of patients, this plant offers the promise of more personalized, precisely controlled medicines. For China, it’s quite a statement; it is a step toward leading in digital pharma manufacturing. But for the rest of the world, it’s more of a wake-up call, because if 3D printed tablets become possible, the supply chain of drugs could change dramatically, from bulk factories to more local, customizable production.
In a way, this is the dream, what many thought was going to happen back when the first 3D printed medicines were released nearly a decade ago. It’s about personalized drugs made faster, closer to patients, and with more precise control. After years of slow progress since Spritam’s debut in 2015, it’s not really that surprising that the next big leap in this niche is happening in China, where Triastek’s new facility could finally push that vision from idea to reality.