SUNSHINE PHARMA (06887.HK): Insulin Degludec/Aspart Injection Wins NMPA Approval

NewTimeSpace News: On 8 October 2026, Sunshine Lake Pharma Co., Ltd. (the "Company") voluntarily announced that the Group's self-developed insulin degludec and insulin aspart injection has been approved for marketing by the National Medical Products Administration (NMPA) of China, in both pen cartridge and pre-filled pen forms. As to the basic product information: the dosage form is an injection, with a specification of 3ml:300 units; the drug approval numbers are S20260074 for the pen cartridge and S20260073 for the pre-filled pen.

The announcement disclosed that the insulin degludec/aspart injection is a dual insulin analogue composed of 70% basal insulin degludec and 30% rapid-acting prandial insulin aspart in a fixed 7:3 ratio, with the two components independently stable and without interfering activity. Insulin degludec provides ultra-long-acting steady release with no obvious peak over 24 hours, steadily controlling fasting and baseline glucose; insulin aspart acts rapidly to effectively suppress postprandial glucose peaks; a single formulation can manage both fasting and postprandial glucose, significantly improving all-day glucose variability and raising HbA1c goal attainment, outperforming traditional premixed insulin. Being a soluble formulation, it is easy to handle and supports flexible dosing once or twice daily, simplifying treatment and reducing injections; it is suitable both for insulin-naive patients and for type 2 diabetes patients whose glucose is poorly controlled, fluctuates widely or who experience frequent hypoglycaemia or cannot tolerate multiple injections.

The Company stated that, with this approval, the Group's approved insulin products in the China market have increased to seven, building a full-series insulin matrix spanning the second to fourth generations and covering basal, prandial and premixed clinical scenarios. On the R&D pipeline, the Group's ultra-long-acting weekly insulin innovative drug HEC-151 has entered Phase I clinical trials, which together with marketed products will form a multi-tier "daily — weekly — combination" product ladder. Internationally, the Group's self-developed insulin glargine injection obtained an approval letter from the US Food and Drug Administration in late April 2026, becoming the fourth insulin glargine product approved in the United States, with the Company becoming the first Chinese pharmaceutical enterprise to launch insulin glargine in the US market; the Group will continue advancing overseas registration of insulin aspart, insulin degludec and other products.

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