In August 2026, injection-grade Sucrose Acetate Isobutyrate (SAIB), independently developed by Jiangsu SinoExci BioPharma Co., Ltd., officially passed the review of the Center for Drug Evaluation (CDE) of the National Medical Products Administration and obtained registration number F20240000294. This marks a key breakthrough for the company in the field of high-end excipients for sustained-release injectables.
Injection-grade SAIB is one of the most critical drug-loading excipients in internationally developed long-acting sustained-release injectables (such as in-situ gel and microsphere formulations). For a long time, this product was predominantly supplied by a few overseas manufacturers, with high prices and long lead times that constrained the R&D and industrialization of domestic long-acting products. Relying on its proprietary synthesis and purification processes, SinoExci completed process development, quality research and registration filing within 18 months, with key indicators such as purity and impurity control reaching advanced international levels.
The company's chairman stated: "The successful registration of injection-grade SAIB is an important milestone in SinoExci's strategy of localizing high-end pharmaceutical excipients. We will continue to invest and work hand in hand with more formulation companies to drive the localization and innovation of long-acting injectables." The product is now available for samples and commercial supply; customers and partners are welcome to discuss cooperation.