SUNSHINE PHARMA (06887) has announced that its self-developed Insulin Degludec Injection has received official market approval from the National Medical Products Administration (NMPA), covering two specifications: cartridge and prefilled injection pen.
Insulin Degludec Injection is a fourth-generation long-acting basal insulin analogue, distinguished by its unique molecular structure and mechanism of action that deliver exceptional clinical performance. Its core clinical advantages include: (1) a half-life of approximately 25 hours and a duration of action exceeding 42 hours, allowing once-daily dosing to cover full-day basal insulin requirements. (2) A stable glucose-lowering profile with blood glucose variability approximately one-quarter that of Insulin Glargine, resulting in minimal fluctuation in drug concentration upon reaching a steady state. (3) Lower rates of confirmed hypoglycemia and nocturnal hypoglycemia compared to Insulin Glargine, reaching statistical significance. Thanks to its ultra-long-acting pharmacokinetic properties, Insulin Degludec Injection can be administered at any time of day without strict timing, significantly improving patient adherence and flexibility.
With the approval of Insulin Degludec Injection, the group's approved insulin products in the Chinese market have expanded to six, building a comprehensive product matrix covering second-generation to fourth-generation insulin, encompassing basal, prandial, and premixed clinical applications. In the research pipeline, the group's Insulin Degludec and Insulin Aspart Dual-Phase Injection is currently under regulatory review for market approval, while the ultra-long-acting once-weekly insulin innovation drug HEC-151 has entered Phase I clinical trials. These will form a multi-tier product portfolio of "daily formulation, weekly formulation, and compound formulation" alongside existing products, ensuring continuous iterative upgrades in the insulin product pipeline.
On the international front, the group's self-developed Insulin Glargine Injection received an approval letter from the U.S. Food and Drug Administration (FDA) at the end of April 2026, becoming the fourth Insulin Glargine product approved in the U.S. market and marking the group as the first Chinese pharmaceutical company to market Insulin Glargine in the United States. Moving forward, the group will continue to advance overseas registration filings for multiple insulin products, including Insulin Aspart and Insulin Degludec, persistently driving the global expansion of its insulin portfolio. This will broaden international market share, enhance the group's global operational capabilities and brand influence, and bring Chinese-developed insulin products to patients worldwide.
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