China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that its New Drug Application (NDA) for a fourth-generation insulin degludec analog has been accepted by the National Medical Products Administration (NMPA) for review. The drug is the first insulin degludec analog to enter the marketing review stage after the originator product, Tresiba.
Drug Profile
Insulin degludec, a next-generation long-acting basal insulin, offers a unique mechanism for prolonged action, with a half-life of ~25 hours and duration of effect up to 42 hours. The analog provides stable glycemic control, low hypoglycemia risk, and flexible dosing (injections can be spaced hours8 apart). A clinical study confirmed its pharmacokinetic and pharmacodynamic similarity to Tresiba, while a Phase III trial met the primary endpoint for glycated hemoglobin, demonstrating efficacy comparable to the originator.-Fineline Info & Tech
