Sunshine Pharma announced that the National Medical Products Administration has granted marketing approval for its self-developed Insulin Degludec Injection in both cartridge and prefilled-pen formats (approval numbers: Guoyaozhunzi S20260058 and S20260059). The product is supplied in a 3 ml/300-unit specification.
Insulin Degludec Injection is a fourth-generation, ultra-long-acting basal insulin analogue with a half-life of roughly 25 hours and a duration of action exceeding 42 hours. Clinical attributes cited by the company include: • Reduced glucose variability to about one-quarter that of insulin glargine; • Statistically significant declines in confirmed and nocturnal hypoglycaemia; • Flexible once-daily administration that is not time-dependent.
With this approval, Sunshine Pharma now markets six insulin products in China, spanning second- to fourth-generation formulations and covering basal, prandial and premixed therapeutic scenarios.
Pipeline progression continues on two fronts: 1) Insulin Degludec/Insulin Aspart Injection has entered marketing authorisation review; 2) HEC-151, a once-weekly ultra-long-acting insulin candidate, is in Phase I trials. These assets are designed to form a tiered portfolio of daily, weekly and combination regimens.
On the international front, the company’s Insulin Glargine Injection received a U.S. FDA approval letter in April 2026, marking the first commercialisation of a PRC-developed insulin glargine in the United States. Sunshine Pharma plans to advance additional overseas filings for insulin aspart, insulin degludec and other products to broaden its global footprint.
Comments