Sunshine Lake Pharma (06887.HK): Insulin Degludec Injection Receives NMPA Marketing Approval; Domestic Insulin Portfolio Expands to 6 Products

NewTimeSpace News: Sunshine Lake Pharma Co., Ltd. (stock code: 6887) announced that its self-developed Insulin Degludec Injection has received marketing approval from China's National Medical Products Administration (NMPA), covering two specifications: cartridge and pre-filled pen, with approval numbers Guoyao Zhunzi S20260058 and S20260059 respectively.

According to the announcement, Insulin Degludec Injection is a fourth-generation long-acting basal insulin analog. Its core clinical advantages include: a half-life of approximately 25 hours and duration of action exceeding 42 hours, enabling once-daily dosing to cover full-day basal insulin requirements; a stable glucose-lowering curve with glycemic variability at approximately one-quarter that of insulin glargine and minimal steady-state blood concentration fluctuations; and a statistically significant lower rate of confirmed hypoglycemia and nocturnal hypoglycemia compared to insulin glargine. Thanks to its ultra-long pharmacokinetic profile, the product can be administered at any time of day without strict fixed injection schedules.

With this approval, the group's insulin products approved in the China market have increased to six, establishing a comprehensive portfolio spanning second- to fourth-generation products and covering three major clinical scenarios: basal, prandial, and premixed insulin. In the R&D pipeline, the insulin degludec/insulin aspart dual formulation is in the marketing registration review stage, while the ultra-long-acting weekly insulin innovative drug HEC-151 has entered Phase I clinical trials. On the international front, the group's self-developed insulin glargine injection received FDA approval in late April 2026, becoming the fourth insulin glargine product launched in the United States and making the company the first Chinese pharmaceutical enterprise to market insulin glargine in the U.S. The group will continue advancing overseas registration for multiple insulin products including insulin aspart and insulin degludec.

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