VISEN Pharmaceuticals (VISEN), an innovative biopharmaceutical company focused on endocrine diseases, announced that the Biologics License Application (BLA) for Lonapegsomatropin (TransCon hGH) was accepted by the China National Medical Products Administration (NMPA). Lonapegsomatropin is the first once-weekly administrated growth hormone approved by both the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of Pediatric Growth Hormone Deficiency (PGHD).

Mr. Pony LU, CEO of VISEN Pharmaceuticals, said, "As the first upcoming commercial product of VISEN Pharmaceuticals, lonapegsomatropin has demonstrated statistically significantly greater efficacy than the daily hGH in the Chinese Phase 3 clinical results. The BLA acceptance represents a significant step towards the product commercialization. We believe that by continuously focusing on providing first-in-class or best-in-class products and treatments, we could provide Chinese endocrine patients with innovative therapies and achieving better treatment processes and outcomes."

Lonapegsomatropin is a prodrug of somatropin administered once weekly. By leveraging the innovative technology platform TransCon^TM (transient conjugation), it is designed to provide sustained release of active, unmodified somatropin, the same growth hormone used in daily pediatric GHD treatments. The unmodified, unbound somatropin released from lonapegsomatropin has the identical 191 amino-acid sequence and size (22 kDa) as endogenous growth hormone.

Lonapegsomatropin and TransCon technology are owned and developed by Ascendis Pharma A/S. VISEN Pharmaceuticals holds exclusive rights to develop, manufacture and commercialize lonapegsomatropin in the Greater China.