TRIASTEK’s 3D-Printed Gastric-Retentive Drug T22 (Riociguat Gastric-Retentive Extended-Release Capsule) Granted NMPA IND Approval

Panda3dp.com has learned that on May 19, 2025, TRIASTEK announced the official approval of its 3D-printed gastric-retentive drug T22 (Riociguat Gastric-Retentive Extended-Release Capsule) for clinical trials by the National Medical Products Administration (NMPA). Previously, the product received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in January 2024. With T22’s IND now approved, both T20G and T22, developed using TRIASTEK’s 3D Microstructure Gastric Retention platform, have successfully entered the clinical phase in both China and the United States.

May 5, 2025, marked the 14th annual World Pulmonary Hypertension Day. Pulmonary hypertension (PH), a commonly encountered hemodynamic disorder, is characterized by rapid progression, high mortality, and disability rates, earning it the grim designation of the “malignant tumor” of the cardiovascular system within the medical community. PH is classified into several types in clinical settings. Among them, pulmonary arterial hypertension (PAH) had a dismal prognosis prior to the advent of targeted therapies, with a median survival of only 2.8 years \[1]; for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who remain untreated, the five-year survival rate in severe cases (mean pulmonary arterial pressure >50 mmHg) is just 10% \[2].

Riociguat is a soluble guanylate cyclase (sGC) stimulator, first approved in the United States in October 2013, and later introduced to the Chinese market in September 2017, for the targeted treatment of PAH and CTEPH. At present, riociguat remains the only approved targeted therapy for CTEPH. However, due to its short half-life, patients must take the drug three times daily.

TRIASTEK’s T22 Riociguat Gastric-Retentive Extended-Release Capsule is a Category 2.2 modified new drug (approved via the 505(b)(2) pathway in the U.S.). It is manufactured using TRIASTEK’s proprietary Melt Extrusion Deposition plus Micro-Injection Molding (MED\&MIM) process and developed based on its patented 3D Microstructure Gastric Retention platform (3DμS®-GR). Compared to the original formulation requiring thrice-daily administration, T22 reduces the dosing frequency to once daily, thereby simplifying the treatment regimen and significantly enhancing patient compliance.

△Dr. Feihuang Deng, Vice President of Technology at TRIASTEK

With T20G and T22 now approved for clinical trials in both China and the United States, the technological maturity of the 3D Microstructure Gastric Retention platform is further validated. TRIASTEK will continue to accelerate clinical development efforts, aiming to deliver higher-quality pharmaceutical solutions to patients worldwide.

References:

[1] D'Alonzo GE, Barst RJ, Ayres SM, et al. Survival in patients with primary pulmonary hypertension: Results from a national prospective registry. Ann Intern Med, 1991, 115(5): 343–349.

[2] Kim NH, Delcroix M, Jais X, et al. Chronic thromboembolic pulmonary hypertension. Eur Respir J, 2019, 53(1): 1801915.