Recently, the pharmaceutical excipient Xylitol (for injection) (F20220000142) from Jiudian Hongyang has been approved by the National Medical Products Administration (NMPA) and has successfully transitioned from the "I" (initial registration) to the "A" (approved) status in the China Drug Evaluation Center (CDE). This marks a significant milestone for the company as the product passes review and is now approved for market release.

Xylitol is an important functional excipient in the field of injectable formulations. While not an active pharmaceutical ingredient (API), it plays a crucial role in ensuring the safety, efficacy, stability, and manufacturability of pharmaceutical products. As an osmotic pressure regulator, xylitol can precisely adjust the osmotic pressure of injectable solutions, significantly reducing vascular irritation, while also providing mild pH buffering effects. In lyophilized powder injections, it serves as an excellent excipient and biological activity protector, ensuring the stability of the drug during storage and use.

Compared to traditional excipients such as sucrose, sorbitol, and glucose, the key advantage of xylitol lies in its insulin-independent metabolic pathway, which provides safe energy and isotonic regulation for patients with glucose metabolism abnormalities. This resolves the clinical challenge of hyperglycemia associated with traditional formulations.

The approval of Xylitol (for injection) further strengthens Jiudian HongYang's leadership position in the injectable excipient market and provides crucial support for domestic pharmaceutical companies to develop more competitive high-end formulations. Moving forward, Jiudian Hongyang will continue to focus on clinical needs, increasing its R&D investment in the high-end pharmaceutical excipient sector. The company is committed to providing more high-performance, reliable excipient products to drive innovation and upgrading in China's pharmaceutical industry.