Hybio Pharmaceutical Co.,Ltd. (300199.SZ) has announced that on May 29, 2026, the company received an EU Decentralised Procedure (DCP) approval document issued by the reference member state, Ireland's Health Products Regulatory Authority (HPRA). The approval pertains to the company's manufactured carbetocin active pharmaceutical ingredient (API).
Carbetocin, as a new-generation potent uterotonic agent, works by binding to oxytocin receptors on uterine smooth muscle, inducing rhythmic uterine contractions. It can also increase the frequency and tension of existing contractions, exhibiting receptor saturation characteristics. It is a synthetic, long-acting oxytocin analogue. Clinical use demonstrates its unique advantages in reducing the incidence of postpartum hemorrhage. Carbetocin offers a prolonged duration of effect and induces stronger uterine contractions, thereby lowering the probability of requiring additional therapeutic uterotonics. Its potency is approximately ten times that of oxytocin, and it also provides greater safety in stabilizing both systolic and diastolic blood pressure.