VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, announced on May 23 top-line results from its pivotal phase 3 trial, a randomized, open-label, active-controlled trial that compared its lonapegsomatropin (TransCon hGH), a once-weekly administered long-acting drug that delivers unmodified growth hormone, to a daily human growth hormone (hGH) in children with growth hormone deficiency (GHD) in China.
The results show that the trial met its primary objective, demonstrating that the lonapegsomatropin was superior to the daily growth hormone on the primary endpoint of annualized height velocity (AHV) at 52 weeks.
VISEN Pharmaceuticals is preparing to submit clinical data as part of its Biologic License Application (BLA) to the National Medical Products Administration (NMPA) of China. It also broke ground on a new facility with an investment of about RMB 600 million in SIP early this year in the aim of establishing a full chain for developing, manufacturing and marketing innovative drugs for endocrine diseases.
May 25, 2022
