Novo Nordisk (NYSE: NVO) announced that its once‑weekly long‑acting growth hormone (LAGH) injection, Sogroya (somapacitan), received approval from China’s National Medical Products Administration (NMPA) for the treatment of growth retardation in children aged 2.5 years and older due to insufficient endogenous growth hormone secretion. The approval is based on the REAL6 Chinese study, which demonstrated comparable height velocity to daily somatropin with a lower treatment burden.
Regulatory Milestone
Item
Details
Approval Date
22 Dec 2025
Agency
NMPA (China)
Product
Sogroya (somapacitan)
Indication
Pediatric growth hormone deficiency (PGHD) in children ≥2.5 years
For Novo Nordisk:First weekly LAGH for PGHD in China; cardiovascular indication (approved simultaneously) creates dual‑indication advantage; REAL6 data validates Chinese patient efficacy; strengthens metabolic disease leadership.
For Patients:Weekly dosing dramatically reduces injection burden vs. daily; low injection site reactions improve tolerability; proven efficacy supports growth normalization.
For Market:LAGH adoption will accelerate as physicians gain experience; pediatric endocrinology will shift toward long‑acting formulations; Novo’s platform positions for future combination therapies (e.g., GIP/GLP‑1 in growth disorders).
Forward‑Looking Statements This brief contains forward‑looking statements regarding Sogroya’s commercial launch, market penetration, and NRDL negotiations. Actual results may differ due to competitive responses, pricing pressures, or patient adoption rates.-Fineline Info & Tech
By Fineline Cube