Growtropin (somatrem biosimilar) / Dong-A - LARVOL DELTA

Long-term Safety and Effectiveness of Growtropin-II Treatment in Children With Short Stature (clinicaltrials.gov) - P=N/A | N=5000 | Recruiting | Sponsor: Dong-A ST Co., Ltd. | N=2500 ➔ 5000 | Trial completion date: Dec 2031 ➔ Feb 2035 | Trial primary completion date: Dec 2031 ➔ Feb 2035

Enrollment change • Trial completion date • Trial primary completion date • Endocrine Disorders • Genetic Disorders • Growth Hormone Deficiency • Idiopathic Short Stature • Small for Gestational Age • Turners Syndrome • IGF1

Dong-A ST sees profit inch down amid rising R&D costs, readies US biosimilar launch (Korea Biomedical Review) - "Prescription drug sales rose 4.8 percent to 443.5 billion won, driven by a 20.5 percent surge in sales of Growtropin, Korea’s first locally developed growth hormone therapy, which brought in 118.9 billion won....Meanwhile, overseas sales jumped 8.3 percent to 151.1 billion won, fueled by higher demand for Bacchus energy drink and sales from IMULDOSA (ustekinumab), a Stelara biosimilar, which contributed 7.5 billion won."

Sales • Crohn's disease • Growth Hormone Deficiency (Pediatric) • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Recombinant Growth Hormone Therapy for Children with Turner Syndrome in Korea: A Phase III Randomized Trial (ENDO 2019) - "This study demonstrated that annualized HV of Growtropin®-II treatment at 52 week is non-inferior to that of Genotropin® in children with TS and there were no significant differences in the change of height SDS, IGF-1 and IGFBP-3 between two groups. Growtropin®-II is well tolerated and its safety profile was comparable with Genotropin® over 1 year of treatment.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

Clinical • P3 data

Recombinant Growth Hormone Therapy for Children with Turner Syndrome in Korea: A Phase III Randomized Trial (ENDO 2019) - "This study demonstrated that annualized HV of Growtropin®-II treatment at 52 week is non-inferior to that of Genotropin® in children with TS and there were no significant differences in the change of height SDS, IGF-1 and IGFBP-3 between two groups. Growtropin®-II is well tolerated and its safety profile was comparable with Genotropin® over 1 year of treatment."

Clinical • P3 data