Visen Pharmaceuticals, a China-based joint venture between Denmark-headquartered Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has published primary data from a pivotal Phase III study for its lonapegsomatropin, also known as TransCon hGH, a once-weekly long-acting growth hormone. The study evaluated the efficacy and safety of lonapegsomatropin in children with growth hormone deficiency (GHD).
Study Results
The China-based study demonstrated that after 52 weeks of treatment, children receiving lonapegsomatropin achieved an annual height velocity (AHV) of 10.66 cm/year, compared to 9.75 cm/year for those treated with daily growth hormone preparations. The difference between the groups was 0.91 cm/year (95% CI: 0.37-1.45, P=0.0010), meeting the primary endpoint of non-inferiority. The pre-set statistical test confirmed that lonapegsomatropin is superior to daily growth hormone preparations. Safety results indicated that the drug was well-tolerated and comparable to daily growth hormone preparations.
Regulatory and Market Context
Visen holds exclusive rights to develop, manufacture, and commercialize lonapegsomatropin in Greater China. The drug, developed globally by Ascendis Pharma A/S, received approval from the US FDA and the European Commission (EC) for pediatric growth hormone deficiency in August 2021 and January 2022, respectively. The positive Phase III results position Visen to further expand the use of lonapegsomatropin in addressing growth hormone deficiency in children.-Fineline Info & Tech
